ICARE: Arm Rehabilitation Study After Stroke

Sponsor

University of Southern California (Other)

Overall Status

Completed

CT.gov ID

NCT00871715

Collaborator

National Institute of Neurological Disorders and Stroke (NINDS) (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)

361

Enrollment

Locations

Arms

Duration (Months)

45.1

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is about arm and hand recovery after a stroke. The investigators are testing an experimental arm therapy called Accelerated Skill Acquisition Program (ASAP) which combines challenging, intensive and meaningful practice of tasks of the participant's choice compared to two standard types of therapy (usual and customary arm therapy totaling 30 hours and usual and customary arm therapy for a duration indicated on the therapy prescription). A second objective is to characterize current outpatient arm therapy (dosage & content) following stroke for individuals who are eligible for ICARE. Eligible candidates must have had a stroke affecting an arm within the last 106 days.

Condition or Disease	Intervention/Treatment	Phase
Stroke Brain Infarction Brain Ischemia Cerebral Infarction Cerebrovascular Disorders	Behavioral: Accelerated Skill Acquisition Program (ASAP) Behavioral: Dose-Equivalent Usual & Customary Care - DEUCC Behavioral: Usual and Customary Care - UCC	N/A

Detailed Description

Of the 700,000 individuals who experience a new or recurrent stroke each year, a majority have considerable residual disability. Sixty-five percent (65%) of patients at 6 months are unable to incorporate the paretic hand effectively into daily activities. In turn, this degree of functional deficit contributes to a reduced quality of life after stroke. The extent of disability has been underplayed by the use of the Barthel Index that captures only basic activities of daily living such as self-care and does not extend to activities and participation at higher levels of functioning that are most affected by a residual upper extremity disability. The past decade has witnessed an explosion of different therapy interventions designed to capitalize on the brain's inherent capability to rewire and learn well into old age and more importantly for rehabilitation, after injury. The most effective arm-focused interventions with the strongest evidence and potentially the most immediate and cost-effective appeal for the current health-care environment share a common emphasis on focused task-specific training applied with an intensity higher than usual care. Therefore, our primary aim is to compare the efficacy of a fully defined, hybrid combination of the most effective interventions (forced-use/constraint-induced therapy and skill-based/impairment-mitigating motor learning training), the Accelerated Skill Acquisition Program (ASAP), to an equivalent dose of usual and customary outpatient therapy.

Study Design

Study Type:

Interventional

Actual Enrollment :

361 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

Blinded to treatment allocation

Primary Purpose:

Treatment

Official Title:

Interdisciplinary Comprehensive Arm Rehab Evaluation (ICARE) Stroke Initiative

Study Start Date :

Jun 1, 2009

Actual Primary Completion Date :

Feb 1, 2014

Actual Study Completion Date :

Feb 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ASAP A focused, intense, evidence-based, upper extremity rehabilitation program, administered during the early post-acute outpatient interval. The training intervention is based on the fundamental elements of skill acquisition through task-specific practice, impairment mitigation to increase capacity, and motivational enhancements to build self-confidence.	Behavioral: Accelerated Skill Acquisition Program (ASAP) A 30-hour dose is administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session precedes the first visit. Other Names: ASAP
Active Comparator: DEUCC Dose-equivalent usual and customary arm therapy administered early post-acutely in the outpatient setting. This is a 30-hour dose equivalency group, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration.	Behavioral: Dose-Equivalent Usual & Customary Care - DEUCC Usual and customary arm therapy administered early post-acutely in the outpatient setting, adjusted for dose, but otherwise administered in accordance with usual and customary practices. This is a 30-hour dose equivalency group, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. Other Names: DEUCC
Other: UCC Usual and customary arm therapy administered early post-acutely in the outpatient setting. This is an observation only group with treatment dose administered in accordance with usual and customary practices.	Behavioral: Usual and Customary Care - UCC Usual and customary arm therapy administered early post-acutely in the outpatient setting. This is an observation only group and treatment dose will be administered in accordance with usual and customary practices. Other Names: UCC

Arm

Intervention/Treatment

Experimental: ASAP

A focused, intense, evidence-based, upper extremity rehabilitation program, administered during the early post-acute outpatient interval. The training intervention is based on the fundamental elements of skill acquisition through task-specific practice, impairment mitigation to increase capacity, and motivational enhancements to build self-confidence.

Behavioral: Accelerated Skill Acquisition Program (ASAP)

A 30-hour dose is administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session precedes the first visit.

Other Names:

ASAP

Active Comparator: DEUCC

Dose-equivalent usual and customary arm therapy administered early post-acutely in the outpatient setting. This is a 30-hour dose equivalency group, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration.

Behavioral: Dose-Equivalent Usual & Customary Care - DEUCC

Usual and customary arm therapy administered early post-acutely in the outpatient setting, adjusted for dose, but otherwise administered in accordance with usual and customary practices. This is a 30-hour dose equivalency group, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration.

Other Names:

DEUCC

Other: UCC

Usual and customary arm therapy administered early post-acutely in the outpatient setting. This is an observation only group with treatment dose administered in accordance with usual and customary practices.

Behavioral: Usual and Customary Care - UCC

Usual and customary arm therapy administered early post-acutely in the outpatient setting. This is an observation only group and treatment dose will be administered in accordance with usual and customary practices.

Other Names:

UCC

Outcome Measures

Primary Outcome Measures

Wolf Motor Function Test (WMFT) Log-transformed Time [Baseline to 1 year post-randomization]
Change from baseline to end-of-study (12 months post-randomization) in log-transformed time required to perform each of the 15 standardized tasks with each upper extremity.
Wolf Motor Function Test Time [Baseline to 1 year post-randomization]
Change from baseline to end-of-study (12 months post-randomization) in time required to perform each of the 15 standardized tasks with each upper extremity.
Stroke Impact Scale (SIS) Hand Function Subscale Score. [Baseline to 1 year post-randomization]
Change from baseline to end-of-study (one year post-randomization). Range: 0-100; positive values reflect an improvement. Higher values indicate better perception of hand function.
Stroke Impact Scale (SIS), Hand Function Subscale, Percentage of Participants That Improved at Least 25 Points From Baseline to End-of-study (One Year Post-randomization) [Baseline to 1 year post-randomization]
The available range for improvement is from 0-100; thus participants with a baseline SIS score greater than 75 (n=15) were excluded from these analyses.

Secondary Outcome Measures

Wolf Motor Function Test (WMFT) Functional Ability Scale (FAS) [Baseline to 1 year post-randomization]
Assesses movement quality via digital media review of task performance post hoc, rated on a 6-point ordinal scale.
Stroke Impact Scale (SIS) Mobility Subscale Score. [Baseline to 1 year post-randomization]
Change from baseline to end-of-study (one year post-randomization). Range: 0-100; positive values reflect an improvement. Higher values indicate better perception of mobility.
Stroke Impact Scale (SIS) ADL/IADL Subscale Score. [Baseline to 1 year post-randomization]
Change from baseline to end-of-study (one year post-randomization). Range: 0-100; positive values reflect an improvement. Higher values indicate better perception of ease with activities queried.
National Institute of Health Stroke Scale (NIHSS) [Baseline to 1 year post-randomization]
Change from baseline to end-of-study (12 months post-randomization) in National Institute of Health Stroke Scale (NIHSS). Range 0-2. Lower scores indicate less stroke severity.
Wolf Motor Function Test (WMFT) Strength Component, Task #7 Weight to Box [Baseline to 1 year post-randomization]
Wolf Motor Function Test (WMFT) strength component, Task #7 Weight to Box, measured in pounds.
Wolf Motor Function Test (WMFT) Strength Component, Task #14 Grip Strength [Baseline to 1 year post-randomization]
Wolf Motor Function Test (WMFT) strength component, Task #14 Grip strength, measured in kilograms, change from baseline to one year post-randomization.
Arm Muscle Torque Test - Elbow Extensors [Baseline to 1 year post-randomization]
Change from baseline to end-of-study (12 months post-randomization) in isometric torque generated as measured in kilograms using a hand held Lafayette manual muscle test dynamometer and standard testing positions.Positive values indicate a strength gain.
Arm Muscle Torque Test - Elbow Flexors [Baseline to 1 year post-randomization]
Change from baseline to end-of-study (12 months post-randomization) in isometric torque generated as measured in kilograms using a hand held Lafayette manual muscle test dynamometer and standard testing positions. Positive values indicate a strength gain.
Arm Muscle Torque Test - Shoulder Extensors [Baseline to 1 year post-randomization]
Change from baseline to end-of-study (12 months post-randomization) in isometric torque generated as measured in kilograms using a hand held Lafayette manual muscle test dynamometer and standard testing positions. Positive values indicate a strength gain.
Arm Muscle Torque Test - Shoulder Flexors [Baseline to 1 year post-randomization]
Change from baseline to end-of-study (12 months post-randomization) in isometric torque generated as measured in kilograms using a hand held Lafayette manual muscle test dynamometer and standard testing positions. Positive values indicate a strength gain.
Arm Muscle Torque Test - Wrist Extensors [Baseline to 1 year post-randomization]
Change from baseline to end-of-study (12 months post-randomization) in isometric torque generated as measured in kilograms using a hand held Lafayette manual muscle test dynamometer and standard testing positions. Positive values indicate a strength gain.
Arm Muscle Torque Test - Wrist Flexors [Baseline to 1 year post-randomization]
Change from baseline to end-of-study (12 months post-randomization) in isometric torque generated as measured in kilograms using a hand held Lafayette manual muscle test dynamometer and standard testing positions. Positive values indicate a strength gain.
As-Tex Sensory Index [Baseline to 1 year post-randomization]
Upper Extremity Fugl Meyer (UEFM), Motor Component [Baseline to 1 year post-randomization]
D-KEFS Verbal Fluency Test [Baseline to 1 year post-randomization]
Digits Span Backward [Baseline to 1 year post-randomization]
Hopkins Verbal Learning Test, Revised (HVLT-R) [Baseline to 1 year post-randomization]
Color Trails Making Tests 1 & 2 [Baseline to 1 year post-randomization]
Short Blessed Memory Test [Baseline to 1 year post-randomization]
Patient Health Questionnaire 9 (PHQ-9) [Baseline to 1 year post-randomization]
Confidence in Arm & Hand Movement (CAHM) [Baseline to 1 year post-randomization]
Stroke Impact Scale (SIS) Communication Subscale Score. [Baseline to 1 year post-randomization]
Change from baseline to end-of-study (one year post-randomization). Range: 0-100; positive values reflect an improvement. Higher values indicate better perceptions of ability to communicate and comprehend.
Stroke Impact Scale (SIS) Emotion Subscale Score. [Baseline to 1 year post-randomization]
Change from baseline to end-of-study (one year post-randomization). Range: 0-100; positive values reflect an improvement. Higher values indicate better perceptions of mood and emotional control.
Motor Activity Log 28 QOM (MAL-28) [Baseline to 1 year post-randomization]
EQ5D [Baseline to 1 year post-randomization]
Satisfaction With Life Scale (SWLS) [Baseline to 1 year post-randomization]
Single-Item Subjective Quality of Life Measurement (SQOL) [Baseline to 1 year post-randomization]
Reintegration to Normal Living Index (RNLI) [Baseline to 1 year post-randomization]

Other Outcome Measures

Monthly Telephone Interviews [monthly, beginning 30 days post-randomization]
A monthly telephone interview with the participant to ascertain information about health status, healthcare utilization, medications, other therapies, and adverse events. Some of these data are reported in the adverse event section. Other data (e.g. those related to healthcare utilization) are part of the secondary analyses presently underway. Until published, these are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.
Post-Intervention Interview [16-20 weeks post-randomization]
A multiple question survey interview, administered by a non-treating, unblinded member of the recruiting team. The participant was asked a set of questions to assess the extent to which critical components of the investigational intervention (e.g. impairment mitigation, session intensity, participant chosen tasks, therapist-participant collaboration) were incorporated into each assigned therapy group. Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.
Exit Interview [Post-intervention to 1 year post-randomization]
A multiple question survey interview, administered by a non-treating, unblinded member of the recruiting team. The participant was asked a set of questions regarding activity since the end of the intervention phase. Participants were also asked to report the perceived value of the intervention and study participation. Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

INCLUSION

Ischemic or hemorrhagic stroke.

Hemiparesis in an upper extremity.

Age 21+.

Able to communicate in English (or Spanish,Rancho Los Amigos site only).

Willing to attend outpatient therapy & f/u evaluations for 1 yr.

Some active finger extension.

EXCLUSION

Traumatic or non-vascular brain injury, subarachnoid hemorrhage, AV malformation.

History of psychiatric illness requiring hospitalization within past 24 mos.

Active drug treatment for dementia.

Neurologic condition that may affect motor response (e.g. Parkinson's, ALS, MS).

History of head trauma requiring >48 hours of hospitalization within past 12 mos.

Amputation of all fingers or thumb of hemiparetic (weak) arm.

Treated with Botox in affected arm within last 3 months.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Southern California	Los Angeles	California	United States	90033
2	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048
3	Rancho Los Amigos National Rehabilitation Center	Los Angeles	California	United States	90242
4	Long Beach Memorial Medical Center	Los Angeles	California	United States	90806
5	Huntington Rehabilitation Medicine Associates	Los Angeles	California	United States	91105
6	Casa Colina Centers for Rehabilitation	Los Angeles	California	United States	91769
7	National Rehabilitation Hospital	Washington	District of Columbia	United States	20010
8	Emory University	Atlanta	Georgia	United States	30322

Sponsors and Collaborators

University of Southern California
National Institute of Neurological Disorders and Stroke (NINDS)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Principal Investigator: Carolee J. Winstein, PhD, PT, University of Southern California
Principal Investigator: Alexander Dromerick, MD, MedStar National Rehabilitation Network
Principal Investigator: Steven Wolf, PhD, PT, Emory University
Study Director: Monica A Nelsen, DPT, PT, University of Southern California

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:

Carolee Winstein, Professor, University of Southern California

ClinicalTrials.gov Identifier:

NCT00871715

Other Study ID Numbers:

U01NS056256
U01NS056256

First Posted:

Mar 30, 2009

Last Update Posted:

Jul 9, 2019

Last Verified:

Jun 1, 2019

Keywords provided by Carolee Winstein, Professor, University of Southern California

task oriented training

task specific training

physical rehabilitation

arm rehabilitation

motor function

Additional relevant MeSH terms:

Stroke

Cerebral Infarction

Cerebrovascular Disorders

Study Results

Participant Flow

Recruitment Details	Participants were recruited between 5 and 106 days post-stroke, predominantly during inpatient rehabilitation, from 7 sites in the United States metropolitan areas of Los Angeles, CA, Atlanta, GA and Washington, D.C.
Pre-assignment Detail	From June 2009 through February 2013, 11,051 patients were pre-screened (medical record review) followed by 772 in-person screening assessments. Through both processes, 9,219 were excluded because they did not meet eligibility criteria; 645 declined and 826 were excluded for other reasons.

Arm/Group Title	ASAP Accelerated Skill Acquisition Program	DEUCC Dose-Equivalent Usual & Customary Care	UCC Usual & Customary Care
Arm/Group Description	A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy. Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit.	Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration.	Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices.
Period Title: Overall Study
STARTED	119	120	122
Post-Intervention	112	115	115
6-mo Follow-up	110	113	112
COMPLETED	104	104	96
NOT COMPLETED	15	16	26

Baseline Characteristics

Arm/Group Title	ASAP Accelerated Skill Acquisition Program	DEUCC Dose-Equivalent Usual & Customary Care	UCC Usual & Customary Care	Total
Arm/Group Description	A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy. Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit.	Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration.	Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices.	Total of all reporting groups
Overall Participants	119	120	122	361
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.9 (13.7)	59.9 (10.5)	61.1 (13.1)	60.7 (12.5)
Sex: Female, Male (Count of Participants)
Female	55 46.2%	53 44.2%	50 41%	158 43.8%
Male	64 53.8%	67 55.8%	72 59%	203 56.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	9 7.6%	14 11.7%	13 10.7%	36 10%
Not Hispanic or Latino	107 89.9%	106 88.3%	107 87.7%	320 88.6%
Unknown or Not Reported	3 2.5%	0 0%	2 1.6%	5 1.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	4 3.4%	1 0.8%	0 0%	5 1.4%
Asian	9 7.6%	7 5.8%	3 2.5%	19 5.3%
Native Hawaiian or Other Pacific Islander	3 2.5%	1 0.8%	3 2.5%	7 1.9%
Black or African American	47 39.5%	50 41.7%	54 44.3%	151 41.8%
White	38 31.9%	43 35.8%	43 35.2%	124 34.3%
More than one race	3 2.5%	3 2.5%	1 0.8%	7 1.9%
Unknown or Not Reported	15 12.6%	15 12.5%	18 14.8%	48 13.3%
Region of Enrollment (participants) [Number]
United States	119 100%	120 100%	122 100%	361 100%
Education (participants) [Number]
Less than high school	4 3.4%	2 1.7%	2 1.6%	8 2.2%
Some high school	6 5%	12 10%	8 6.6%	26 7.2%
Completed high school	24 20.2%	21 17.5%	27 22.1%	72 19.9%
Some college	42 35.3%	42 35%	46 37.7%	130 36%
Completed bachelor's degree	22 18.5%	26 21.7%	23 18.9%	71 19.7%
Completed master's degree	15 12.6%	11 9.2%	7 5.7%	33 9.1%
Completed doctoral degree	6 5%	6 5%	8 6.6%	20 5.5%
Unknown or Not Reported	0 0%	0 0%	1 0.8%	1 0.3%
Referral source (participants) [Number]
Inpatient rehabilitation	80 67.2%	79 65.8%	88 72.1%	247 68.4%
Outpatient	6 5%	5 4.2%	5 4.1%	16 4.4%
Acute care	21 17.6%	26 21.7%	19 15.6%	66 18.3%
Transitional day program	3 2.5%	2 1.7%	2 1.6%	7 1.9%
Open referral	9 7.6%	7 5.8%	8 6.6%	24 6.6%
Other	0 0%	1 0.8%	0 0%	1 0.3%
Language (participants) [Number]
English	117 98.3%	119 99.2%	121 99.2%	357 98.9%
Spanish	2 1.7%	1 0.8%	1 0.8%	4 1.1%
Time from stroke to randomization (days) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [days]	45.2 (20.3)	45.0 (22.8)	47.0 (23.9)	45.8 (22.4)
Stroke type (participants) [Number]
Ischemic without hemorrhagic conversion	100 84%	98 81.7%	101 82.8%	299 82.8%
Ischemic with hemorrhagic conversion	3 2.5%	4 3.3%	4 3.3%	11 3%
Intraparenchymal hemorrhagic	16 13.4%	12 10%	15 12.3%	43 11.9%
Other	0 0%	5 4.2%	1 0.8%	6 1.7%
Unknown or Not Reported	0 0%	1 0.8%	1 0.8%	2 0.6%
Stroke location (participants) [Number]
Right hemisphere	57 47.9%	56 46.7%	60 49.2%	173 47.9%
Left hemisphere	49 41.2%	55 45.8%	50 41%	154 42.7%
Cerebellum	0 0%	1 0.8%	0 0%	1 0.3%
Brain stem	11 9.2%	5 4.2%	9 7.4%	25 6.9%
Other	2 1.7%	3 2.5%	3 2.5%	8 2.2%
Side of hemiparesis (participants) [Number]
Right	51 42.9%	60 50%	57 46.7%	168 46.5%
Left	68 57.1%	60 50%	65 53.3%	193 53.5%
Stroke severity (units on a scale) [Mean (Standard Deviation) ]
Upper Extremity Motor Fugl-Meyer score	41.7 (9.5)	41.5 (9.2)	41.6 (9.5)	41.6 (9.4)
National Institutes of Health Stroke Scale score	3.6 (2.0)	3.4 (1.7)	3.7 (1.7)	3.6 (1.8)
Strata (participants) [Number]
Low severity, early onset	68 57.1%	70 58.3%	67 54.9%	205 56.8%
Low severity, late onset	16 13.4%	16 13.3%	18 14.8%	50 13.9%
High severity, early onset	23 19.3%	22 18.3%	25 20.5%	70 19.4%
High severity, late onset	12 10.1%	12 10%	12 9.8%	36 10%
Concordance (participants) [Number]
Concordant	55 46.2%	64 53.3%	57 46.7%	176 48.8%
Discordant	64 53.8%	56 46.7%	65 53.3%	185 51.2%
Pre-randomization outpatient occupational therapy (participants) [Number]
Number [participants]	34 28.6%	29 24.2%	42 34.4%	105 29.1%
Amount of pre-randomization outpatient occupational therapy (hours) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [hours]	4.4 (3.1)	3.3 (2.3)	3.7 (3.4)	3.8 (3.0)

Outcome Measures

1. Primary Outcome

Title	Wolf Motor Function Test (WMFT) Log-transformed Time
Description	Change from baseline to end-of-study (12 months post-randomization) in log-transformed time required to perform each of the 15 standardized tasks with each upper extremity.
Time Frame	Baseline to 1 year post-randomization

Outcome Measure Data

Analysis Population Description
Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data.

Arm/Group Title	ASAP Accelerated Skill Acquisition Program	DEUCC Dose-Equivalent Usual & Customary Care	UCC Usual & Customary Care
Arm/Group Description	A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy. Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit.	Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration.	Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices.
Measure Participants	104	104	96
Mean (95% Confidence Interval) [log(seconds)]	-0.8	-0.9	-0.8

2. Primary Outcome

Title	Wolf Motor Function Test Time
Description	Change from baseline to end-of-study (12 months post-randomization) in time required to perform each of the 15 standardized tasks with each upper extremity.
Time Frame	Baseline to 1 year post-randomization

Outcome Measure Data

Analysis Population Description
Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data.

Arm/Group Title	ASAP Accelerated Skill Acquisition Program	DEUCC Dose-Equivalent Usual & Customary Care	UCC Usual & Customary Care
Arm/Group Description	A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy. Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit.	Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration.	Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices.
Measure Participants	104	104	96
Mean (95% Confidence Interval) [seconds]	-8.1	-8.7	-7.5

3. Primary Outcome

Title	Stroke Impact Scale (SIS) Hand Function Subscale Score.
Description	Change from baseline to end-of-study (one year post-randomization). Range: 0-100; positive values reflect an improvement. Higher values indicate better perception of hand function.
Time Frame	Baseline to 1 year post-randomization

Outcome Measure Data

Analysis Population Description
Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data.

Arm/Group Title	ASAP Accelerated Skill Acquisition Program	DEUCC Dose-Equivalent Usual & Customary Care	UCC Usual & Customary Care
Arm/Group Description	A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy. Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit.	Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration.	Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices.
Measure Participants	105	107	101
Mean (95% Confidence Interval) [units on a scale]	37.6	35.7	37.1

4. Primary Outcome

Title	Stroke Impact Scale (SIS), Hand Function Subscale, Percentage of Participants That Improved at Least 25 Points From Baseline to End-of-study (One Year Post-randomization)
Description	The available range for improvement is from 0-100; thus participants with a baseline SIS score greater than 75 (n=15) were excluded from these analyses.
Time Frame	Baseline to 1 year post-randomization

Outcome Measure Data

Analysis Population Description
Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data.

Arm/Group Title	ASAP Accelerated Skill Acquisition Program	DEUCC Dose-Equivalent Usual & Customary Care	UCC Usual & Customary Care
Arm/Group Description	A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy. Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit.	Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration.	Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices.
Measure Participants	99	104	99
Number [percentage of participants]	72.7 61.1%	72.1 60.1%	68.7 56.3%

5. Secondary Outcome

Title	Wolf Motor Function Test (WMFT) Functional Ability Scale (FAS)
Description	Assesses movement quality via digital media review of task performance post hoc, rated on a 6-point ordinal scale.
Time Frame	Baseline to 1 year post-randomization

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title
Arm/Group Description

6. Secondary Outcome

Title	Stroke Impact Scale (SIS) Mobility Subscale Score.
Description	Change from baseline to end-of-study (one year post-randomization). Range: 0-100; positive values reflect an improvement. Higher values indicate better perception of mobility.
Time Frame	Baseline to 1 year post-randomization

Outcome Measure Data

Analysis Population Description
Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data.

Arm/Group Title	ASAP Accelerated Skill Acquisition Program	DEUCC Dose-Equivalent Usual & Customary Care	UCC Usual & Customary Care
Arm/Group Description	A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy. Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit.	Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration.	Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices.
Measure Participants	105	107	101
Mean (Standard Deviation) [units on a scale]	11.22 (22.53)	12.08 (21.15)	14.91 (22.6)

7. Secondary Outcome

Title	Stroke Impact Scale (SIS) ADL/IADL Subscale Score.
Description	Change from baseline to end-of-study (one year post-randomization). Range: 0-100; positive values reflect an improvement. Higher values indicate better perception of ease with activities queried.
Time Frame	Baseline to 1 year post-randomization

Outcome Measure Data

Analysis Population Description
Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data.

Arm/Group Title	ASAP Accelerated Skill Acquisition Program	DEUCC Dose-Equivalent Usual & Customary Care	UCC Usual & Customary Care
Arm/Group Description	A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy. Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit.	Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration.	Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices.
Measure Participants	105	107	101
Mean (Standard Deviation) [units on a scale]	22.69 (20.33)	21.53 (18.76)	23.22 (18.88)

8. Secondary Outcome

Title	National Institute of Health Stroke Scale (NIHSS)
Description	Change from baseline to end-of-study (12 months post-randomization) in National Institute of Health Stroke Scale (NIHSS). Range 0-2. Lower scores indicate less stroke severity.
Time Frame	Baseline to 1 year post-randomization

Outcome Measure Data

Analysis Population Description
Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data.

Arm/Group Title	ASAP Accelerated Skill Acquisition Program	DEUCC Dose-Equivalent Usual & Customary Care	UCC Usual & Customary Care
Arm/Group Description	A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy. Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit.	Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration.	Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices.
Measure Participants	104	104	91
Mean (Standard Deviation) [score on a scale]	-1.67 (2.28)	-1.61 (1.79)	-1.76 (1.7)

9. Secondary Outcome

Title	Wolf Motor Function Test (WMFT) Strength Component, Task #7 Weight to Box
Description	Wolf Motor Function Test (WMFT) strength component, Task #7 Weight to Box, measured in pounds.
Time Frame	Baseline to 1 year post-randomization

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title
Arm/Group Description

10. Secondary Outcome

Title	Wolf Motor Function Test (WMFT) Strength Component, Task #14 Grip Strength
Description	Wolf Motor Function Test (WMFT) strength component, Task #14 Grip strength, measured in kilograms, change from baseline to one year post-randomization.
Time Frame	Baseline to 1 year post-randomization

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title
Arm/Group Description

11. Secondary Outcome

Title	Arm Muscle Torque Test - Elbow Extensors
Description	Change from baseline to end-of-study (12 months post-randomization) in isometric torque generated as measured in kilograms using a hand held Lafayette manual muscle test dynamometer and standard testing positions.Positive values indicate a strength gain.
Time Frame	Baseline to 1 year post-randomization

Outcome Measure Data

Analysis Population Description
Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data.

Arm/Group Title	ASAP Accelerated Skill Acquisition Program	DEUCC Dose-Equivalent Usual & Customary Care	UCC Usual & Customary Care
Arm/Group Description	A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy. Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit.	Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration.	Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices.
Measure Participants	95	98	85
Mean (Standard Deviation) [kilograms]	20.0 (47.33)	15.73 (48.10)	14.58 (50.28)

12. Secondary Outcome

Title	Arm Muscle Torque Test - Elbow Flexors
Description	Change from baseline to end-of-study (12 months post-randomization) in isometric torque generated as measured in kilograms using a hand held Lafayette manual muscle test dynamometer and standard testing positions. Positive values indicate a strength gain.
Time Frame	Baseline to 1 year post-randomization

Outcome Measure Data

Analysis Population Description
Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data.

Arm/Group Title	ASAP Accelerated Skill Acquisition Program	DEUCC Dose-Equivalent Usual & Customary Care	UCC Usual & Customary Care
Arm/Group Description	A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy. Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit.	Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration.	Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices.
Measure Participants	95	99	85
Mean (Standard Deviation) [kilograms]	30.41 (52.03)	20.78 (56.39)	24.21 (45.13)

13. Secondary Outcome

Title	Arm Muscle Torque Test - Shoulder Extensors
Description	Change from baseline to end-of-study (12 months post-randomization) in isometric torque generated as measured in kilograms using a hand held Lafayette manual muscle test dynamometer and standard testing positions. Positive values indicate a strength gain.
Time Frame	Baseline to 1 year post-randomization

Outcome Measure Data

Analysis Population Description
Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data.

Arm/Group Title	ASAP Accelerated Skill Acquisition Program	DEUCC Dose-Equivalent Usual & Customary Care	UCC Usual & Customary Care
Arm/Group Description	A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy. Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit.	Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration.	Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices.
Measure Participants	91	94	79
Mean (Standard Deviation) [kilograms]	25.61 (56.63)	20.76 (55.23)	18.64 (59.04)

14. Secondary Outcome

Title	Arm Muscle Torque Test - Shoulder Flexors
Description	Change from baseline to end-of-study (12 months post-randomization) in isometric torque generated as measured in kilograms using a hand held Lafayette manual muscle test dynamometer and standard testing positions. Positive values indicate a strength gain.
Time Frame	Baseline to 1 year post-randomization

Outcome Measure Data

Analysis Population Description
Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data.

Arm/Group Title	ASAP Accelerated Skill Acquisition Program	DEUCC Dose-Equivalent Usual & Customary Care	UCC Usual & Customary Care
Arm/Group Description	A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy. Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit.	Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration.	Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices.
Measure Participants	90	93	79
Mean (Standard Deviation) [kilograms]	21.41 (57.12)	24.4 (51.90)	19.74 (47.86)

15. Secondary Outcome

Title	Arm Muscle Torque Test - Wrist Extensors
Description	Change from baseline to end-of-study (12 months post-randomization) in isometric torque generated as measured in kilograms using a hand held Lafayette manual muscle test dynamometer and standard testing positions. Positive values indicate a strength gain.
Time Frame	Baseline to 1 year post-randomization

Outcome Measure Data

Analysis Population Description
Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data.

Arm/Group Title	ASAP Accelerated Skill Acquisition Program	DEUCC Dose-Equivalent Usual & Customary Care	UCC Usual & Customary Care
Arm/Group Description	A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy. Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit.	Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration.	Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices.
Measure Participants	95	97	85
Mean (Standard Deviation) [kilograms]	15.19 (37.59)	18.07 (34.03)	18.12 (32.07)

16. Secondary Outcome

Title	Arm Muscle Torque Test - Wrist Flexors
Description	Change from baseline to end-of-study (12 months post-randomization) in isometric torque generated as measured in kilograms using a hand held Lafayette manual muscle test dynamometer and standard testing positions. Positive values indicate a strength gain.
Time Frame	Baseline to 1 year post-randomization

Outcome Measure Data

Analysis Population Description
Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data.

Arm/Group Title	ASAP Accelerated Skill Acquisition Program	DEUCC Dose-Equivalent Usual & Customary Care	UCC Usual & Customary Care
Arm/Group Description	A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy. Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit.	Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration.	Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices.
Measure Participants	93	99	85
Mean (Standard Deviation) [kilograms]	16.24 (39.37)	10.71 (30.21)	8.96 (28.76)

17. Secondary Outcome

Title	As-Tex Sensory Index
Description
Time Frame	Baseline to 1 year post-randomization

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title
Arm/Group Description

18. Secondary Outcome

Title	Upper Extremity Fugl Meyer (UEFM), Motor Component
Description
Time Frame	Baseline to 1 year post-randomization

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title
Arm/Group Description

19. Secondary Outcome

Title	D-KEFS Verbal Fluency Test
Description
Time Frame	Baseline to 1 year post-randomization

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title
Arm/Group Description

20. Secondary Outcome

Title	Digits Span Backward
Description
Time Frame	Baseline to 1 year post-randomization

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title
Arm/Group Description

21. Secondary Outcome

Title	Hopkins Verbal Learning Test, Revised (HVLT-R)
Description
Time Frame	Baseline to 1 year post-randomization

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title
Arm/Group Description

22. Secondary Outcome

Title	Color Trails Making Tests 1 & 2
Description
Time Frame	Baseline to 1 year post-randomization

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title
Arm/Group Description

23. Secondary Outcome

Title	Short Blessed Memory Test
Description
Time Frame	Baseline to 1 year post-randomization

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title
Arm/Group Description

24. Secondary Outcome

Title	Patient Health Questionnaire 9 (PHQ-9)
Description
Time Frame	Baseline to 1 year post-randomization

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title
Arm/Group Description

25. Secondary Outcome

Title	Confidence in Arm & Hand Movement (CAHM)
Description
Time Frame	Baseline to 1 year post-randomization

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title
Arm/Group Description

26. Secondary Outcome

Title	Stroke Impact Scale (SIS) Communication Subscale Score.
Description	Change from baseline to end-of-study (one year post-randomization). Range: 0-100; positive values reflect an improvement. Higher values indicate better perceptions of ability to communicate and comprehend.
Time Frame	Baseline to 1 year post-randomization

Outcome Measure Data

Analysis Population Description
Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data.

Arm/Group Title	ASAP Accelerated Skill Acquisition Program	DEUCC Dose-Equivalent Usual & Customary Care	UCC Usual & Customary Care
Arm/Group Description	A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy. Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit.	Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration.	Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices.
Measure Participants	105	107	101
Mean (Standard Deviation) [units on a scale]	6.23 (17.38)	2.97 (14.67)	3.11 (13.05)

27. Secondary Outcome

Title	Stroke Impact Scale (SIS) Emotion Subscale Score.
Description	Change from baseline to end-of-study (one year post-randomization). Range: 0-100; positive values reflect an improvement. Higher values indicate better perceptions of mood and emotional control.
Time Frame	Baseline to 1 year post-randomization

Outcome Measure Data

Analysis Population Description
Number analyzed reflects actual evaluations completed, which varied by outcome assessment. All analyses were also performed in accord with the pre-planned intent-to-treat (ITT) principle with multiple imputation, comparing outcomes by assigned group. No differences were observed between imputed models and actual complete case data.

Arm/Group Title	ASAP Accelerated Skill Acquisition Program	DEUCC Dose-Equivalent Usual & Customary Care	UCC Usual & Customary Care
Arm/Group Description	A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy. Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit.	Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration.	Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices.
Measure Participants	105	107	101
Mean (Standard Deviation) [units on a scale]	3.49 (17.81)	3.63 (17.21)	3.36 (15.52)

28. Secondary Outcome

Title	Motor Activity Log 28 QOM (MAL-28)
Description
Time Frame	Baseline to 1 year post-randomization

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title
Arm/Group Description

29. Secondary Outcome

Title	EQ5D
Description
Time Frame	Baseline to 1 year post-randomization

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title
Arm/Group Description

30. Secondary Outcome

Title	Satisfaction With Life Scale (SWLS)
Description
Time Frame	Baseline to 1 year post-randomization

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title
Arm/Group Description

31. Secondary Outcome

Title	Single-Item Subjective Quality of Life Measurement (SQOL)
Description
Time Frame	Baseline to 1 year post-randomization

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title
Arm/Group Description

32. Secondary Outcome

Title	Reintegration to Normal Living Index (RNLI)
Description
Time Frame	Baseline to 1 year post-randomization

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title
Arm/Group Description

33. Other Pre-specified Outcome

Title	Monthly Telephone Interviews
Description	A monthly telephone interview with the participant to ascertain information about health status, healthcare utilization, medications, other therapies, and adverse events. Some of these data are reported in the adverse event section. Other data (e.g. those related to healthcare utilization) are part of the secondary analyses presently underway. Until published, these are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.
Time Frame	monthly, beginning 30 days post-randomization

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title
Arm/Group Description

34. Other Pre-specified Outcome

Title	Post-Intervention Interview
Description	A multiple question survey interview, administered by a non-treating, unblinded member of the recruiting team. The participant was asked a set of questions to assess the extent to which critical components of the investigational intervention (e.g. impairment mitigation, session intensity, participant chosen tasks, therapist-participant collaboration) were incorporated into each assigned therapy group. Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.
Time Frame	16-20 weeks post-randomization

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title
Arm/Group Description

35. Other Pre-specified Outcome

Title	Exit Interview
Description	A multiple question survey interview, administered by a non-treating, unblinded member of the recruiting team. The participant was asked a set of questions regarding activity since the end of the intervention phase. Participants were also asked to report the perceived value of the intervention and study participation. Publication of secondary analyses (outcome measures #5-25) are underway, and until published, they are embargoed information. Once published, these data will be made available via ClinicalTrials.gov.
Time Frame	Post-intervention to 1 year post-randomization

Outcome Measure Data

Analysis Population Description
[Not Specified]

Arm/Group Title
Arm/Group Description

Adverse Events

	ASAP Accelerated Skill Acquisition Program		DEUCC Dose-Equivalent Usual & Customary Care		UCC Usual & Customary Care		Screened But Not Randomized
Time Frame	From consent to in-person screening (minimum of 5 days post-stroke) up to one year post-randomization (maximum of 471 days post-stroke). Adverse events were not monitored for individuals with medical record screens only.
Adverse Event Reporting Description	Participants were monitored for adverse events during all screening, intervention and evaluation sessions. Additionally, participants or their representatives were contacted by phone monthly to assess health status, health care utilization, medication use and occurrence of adverse events. A single event may involve more that one category.

Arm/Group Title	ASAP Accelerated Skill Acquisition Program		DEUCC Dose-Equivalent Usual & Customary Care		UCC Usual & Customary Care		Screened But Not Randomized
Arm/Group Description	A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy. Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit.		Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration.		Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity. Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices.		Individuals who consented to an in-person screening assessment for eligibility but were never randomized.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	ASAP Accelerated Skill Acquisition Program		DEUCC Dose-Equivalent Usual & Customary Care		UCC Usual & Customary Care		Screened But Not Randomized
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	37/119 (31.1%)		36/120 (30%)		32/122 (26.2%)		4/772 (0.5%)
Cardiac disorders
MI or Acute Coronary Syndrome	1/119 (0.8%)	1	3/120 (2.5%)	3	4/122 (3.3%)	6	0/772 (0%)	0
New onset of Cardiac Arrhythmia	2/119 (1.7%)	2	1/120 (0.8%)	1	2/122 (1.6%)	2	0/772 (0%)	0
General disorders
Death	1/119 (0.8%)	1	1/120 (0.8%)	1	2/122 (1.6%)	2	0/772 (0%)	0
Inpatient Hospitalization or ER visit >23 hours	28/119 (23.5%)	45	32/120 (26.7%)	46	28/122 (23%)	48	4/772 (0.5%)	4
Unexpected/Other	2/119 (1.7%)	2	1/120 (0.8%)	1	0/122 (0%)	0	1/772 (0.1%)	1
Musculoskeletal and connective tissue disorders
Fracture	5/119 (4.2%)	6	5/120 (4.2%)	5	6/122 (4.9%)	6	0/772 (0%)	0
Nervous system disorders
Recurrent Stroke or TIA	13/119 (10.9%)	18	9/120 (7.5%)	13	7/122 (5.7%)	9	2/772 (0.3%)	2
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism	0/119 (0%)	0	0/120 (0%)	0	0/122 (0%)	0	0/772 (0%)	0
Dyspnea	2/119 (1.7%)	2	0/120 (0%)	0	2/122 (1.6%)	2	0/772 (0%)	0
Vascular disorders
Excessive blood pressure response	1/119 (0.8%)	1	1/120 (0.8%)	1	3/122 (2.5%)	3	1/772 (0.1%)	1
Other (Not Including Serious) Adverse Events
	ASAP Accelerated Skill Acquisition Program		DEUCC Dose-Equivalent Usual & Customary Care		UCC Usual & Customary Care		Screened But Not Randomized
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	67/119 (56.3%)		69/120 (57.5%)		55/122 (45.1%)		1/772 (0.1%)
General disorders
Fall with No Fracture	41/119 (34.5%)	67	32/120 (26.7%)	41	23/122 (18.9%)	28	0/772 (0%)	0
Dizziness/Fainting	10/119 (8.4%)	12	13/120 (10.8%)	14	9/122 (7.4%)	10	0/772 (0%)	0
Unexpected SAEs	10/119 (8.4%)	11	12/120 (10%)	12	7/122 (5.7%)	8	0/772 (0%)	0
Musculoskeletal and connective tissue disorders
Muscle soreness or pain that persists for more than 48 hours	29/119 (24.4%)	53	27/120 (22.5%)	29	29/122 (23.8%)	38	0/772 (0%)	0
Shoulder pain that limits study participation	16/119 (13.4%)	24	17/120 (14.2%)	19	20/122 (16.4%)	27	0/772 (0%)	0
Respiratory, thoracic and mediastinal disorders
Dyspnea	4/119 (3.4%)	7	6/120 (5%)	6	3/122 (2.5%)	5	0/772 (0%)	0
Skin and subcutaneous tissue disorders
Open sore or cuts	8/119 (6.7%)	10	13/120 (10.8%)	15	4/122 (3.3%)	6	0/772 (0%)	0
Vascular disorders
Excessive blood pressure response	15/119 (12.6%)	30	15/120 (12.5%)	18	3/122 (2.5%)	4	1/772 (0.1%)	1
Deep Vein Thrombosis	2/119 (1.7%)	2	0/120 (0%)	0	1/122 (0.8%)	1	0/772 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title	Carolee Winstein, Principal Investigator
Organization	University of Southern California
Phone	3234422903
Email	winstein@usc.edu

Responsible Party:

Carolee Winstein, Professor, University of Southern California

ClinicalTrials.gov Identifier:

NCT00871715

Other Study ID Numbers:

U01NS056256
U01NS056256

First Posted:

Mar 30, 2009

Last Update Posted:

Jul 9, 2019

Last Verified:

Jun 1, 2019

ICARE: Arm Rehabilitation Study After Stroke

Study Details

Study Description

Brief Summary

Detailed Description

Study Design

Arms and Interventions

Outcome Measures

Primary Outcome Measures

Secondary Outcome Measures

Other Outcome Measures

Eligibility Criteria

Criteria

Contacts and Locations

Locations

Sponsors and Collaborators

Investigators

Study Documents (Full-Text)

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Additional Information:

Publications

Study Results

Participant Flow

Baseline Characteristics

Outcome Measures

Outcome Measure Data

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Outcome Measure Data

Adverse Events

All Cause Mortality

Serious Adverse Events

Other (Not Including Serious) Adverse Events

Limitations/Caveats

More Information

Certain Agreements

Results Point of Contact