HAAPI: Rehabilitation of the Stroke Hand at Home
Study Details
Study Description
Brief Summary
The purpose of this research is to evaluate a therapy delivery system for stroke patients that provide accessible, affordable stroke care. User-friendly home therapy robots and a telerehabilitation system are combined to monitor and provide therapy that is accessible for patients in rural and underserved locations. The robotic-based home therapy intervention will produce significantly greater improvement in upper extremity motor function than Usual and Customary Care enhanced with a (non-robotic) home therapy upper extremity rehabilitation program at the end of 8 weeks of home therapy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
The primary purpose of this proposal is to evaluate a combined clinic/home robotic-based stroke therapy delivery and monitoring system in rural and underserved locations that provides accessible, effective and affordable care for stroke survivors with residual limb impairment. The study is a prospective, single-blind, multi-site Randomized Controlled Trial. A total of 96 patients within 6 months post-stroke will be enrolled and randomly assigned to one of two groups: robotic based home therapy or a self administered (non-robotic) home therapy program.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Hand Mentor Therapy Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks |
Device: Hand Mentor (TM) robotic stroke therapy device
The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance.
|
| Active Comparator: Control Self administered home therapy program |
Device: Home Therapy Program
Subjects in the control group will be instructed in a self administered home therapy program
|
Outcome Measures
Primary Outcome Measures
- Action Research Arm Test (ARAT) [End of treatment at 8 weeks post enrolment]
The amount of recovery of arm-hand function is measured with the Action Research Arm Test (ARAT). The ARAT assesses activity limitations of the upper extremity. It includes 19 items divided into four subscales: grasp, grip, pinch, and gross movement. Scores range from 0-to-57 with a higher score indicating a better outcome.
Secondary Outcome Measures
- Wolf Motor Function Test [End of treatment at 8 weeks post enrolment]
The Wolf Motor Function Test (WMFT) is used to measure the degree of function using timed tasks. The WMFT is a 17-item measure used to assess activity limitations of the upper extremity. It is comprised of 2 strength items and 15 timed task performance items. The task performance items begin with the measurement of simple proximal movements and progress to more complex distal and whole limb movements. The WMFT yields two scores: 1) a functional ability score quantifying quality of performance, and 2) a timed score quantifying speed of performance in seconds. A shorter time is better outcome.
- Fugl-Meyer Upper Extremity Test [End of Treatment at 8 weeks post enrolment]
Upper Extremity neurological impairment will be measured using the Fugl-Meyer Upper Extremity Test (FMA). The FMA is an impairment-based measure consisting of 33 movements with higher scores indicating increased ability of the patient to move out of synergistic patterns toward more isolated movements. Movement quality of the affected UE is compared to the non-affected UE on 0-2 ordinal scale with 0 indicating no movement at all, 1 indicating partial movement of the affected extremity, and 2 indicating movement equivalent to the non-affected UEs. The score ranges from 0-to-66.
- Stroke Impact Scale (SIS) [End of treatment at 8 weeks post enrolment]
Quality of Life changes are measured with the Stroke Impact Scale questionnaire. The SIS is a self-rated QOL questionnaire that addresses several domains following stroke: physical strength, memory, feelings and emotions, communication, activities of daily living (ADL), mobility, hand use, meaningful activities, and overall percentage recovery from the stroke. We report the Hand Function subscale, which ranges from 0-to-100. A higher score reflects better hand function.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Unilateral ischemic or hemorrhagic stroke
-
within 6 months of admission to in-patient rehabilitation
-
Persistent hemiparesis
-
Proximal Upper Extremity voluntary activity
-
Preserved cognitive function
-
Difficult access to an organized stroke rehabilitation program
Exclusion Criteria:
-
Not independent before stroke
-
Hemispatial neglect
-
Significant other illnesses
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Emory University School of Medicine | Atlanta | Georgia | United States | 30322 |
| 2 | Cleveland Clinic Foujndation | Cleveland | Ohio | United States | 44195 |
Sponsors and Collaborators
- Kinetic Muscles
- The Cleveland Clinic
- Emory University
- National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
- Principal Investigator: Jay Alberts, PhD, The Cleveland Clinic
- Principal Investigator: Steve L Wolf, PhD, Emory University Medical School
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NS070646
- 1RC3NS070646-01
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Hand Mentor Therapy | Control |
|---|---|---|
| Arm/Group Description | Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance. | Self administered home therapy program Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program |
| Period Title: Overall Study | ||
| STARTED | 51 | 48 |
| COMPLETED | 47 | 45 |
| NOT COMPLETED | 4 | 3 |
Baseline Characteristics
| Arm/Group Title | Hand Mentor Therapy | Control | Total |
|---|---|---|---|
| Arm/Group Description | Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance. | Self administered home therapy program Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program | Total of all reporting groups |
| Overall Participants | 51 | 48 | 99 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
54.7
(12.2)
|
59.1
(14.1)
|
57.5
(13.3)
|
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
38
74.5%
|
36
75%
|
74
74.7%
|
| >=65 years |
13
25.5%
|
12
25%
|
25
25.3%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
20
39.2%
|
15
31.3%
|
35
35.4%
|
| Male |
31
60.8%
|
33
68.8%
|
64
64.6%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
2
4.2%
|
2
2%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
22
43.1%
|
26
54.2%
|
48
48.5%
|
| White |
28
54.9%
|
20
41.7%
|
48
48.5%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
1
2%
|
0
0%
|
1
1%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
2
3.9%
|
0
0%
|
2
2%
|
| Not Hispanic or Latino |
48
94.1%
|
48
100%
|
96
97%
|
| Unknown or Not Reported |
1
2%
|
0
0%
|
1
1%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
51
100%
|
48
100%
|
99
100%
|
Outcome Measures
| Title | Action Research Arm Test (ARAT) |
|---|---|
| Description | The amount of recovery of arm-hand function is measured with the Action Research Arm Test (ARAT). The ARAT assesses activity limitations of the upper extremity. It includes 19 items divided into four subscales: grasp, grip, pinch, and gross movement. Scores range from 0-to-57 with a higher score indicating a better outcome. |
| Time Frame | End of treatment at 8 weeks post enrolment |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Hand Mentor Therapy | Control |
|---|---|---|
| Arm/Group Description | Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance. | Self administered home therapy program Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program |
| Measure Participants | 51 | 48 |
| Mean (Standard Deviation) [units on a scale] |
39.47
(19.83)
|
39.89
(17.13)
|
| Title | Wolf Motor Function Test |
|---|---|
| Description | The Wolf Motor Function Test (WMFT) is used to measure the degree of function using timed tasks. The WMFT is a 17-item measure used to assess activity limitations of the upper extremity. It is comprised of 2 strength items and 15 timed task performance items. The task performance items begin with the measurement of simple proximal movements and progress to more complex distal and whole limb movements. The WMFT yields two scores: 1) a functional ability score quantifying quality of performance, and 2) a timed score quantifying speed of performance in seconds. A shorter time is better outcome. |
| Time Frame | End of treatment at 8 weeks post enrolment |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Hand Mentor Therapy | Control |
|---|---|---|
| Arm/Group Description | Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance. | Self administered home therapy program Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program |
| Measure Participants | 51 | 48 |
| Geometric Mean (Standard Deviation) [Seconds] |
8.67
(4.76)
|
7.92
(3.97)
|
| Title | Fugl-Meyer Upper Extremity Test |
|---|---|
| Description | Upper Extremity neurological impairment will be measured using the Fugl-Meyer Upper Extremity Test (FMA). The FMA is an impairment-based measure consisting of 33 movements with higher scores indicating increased ability of the patient to move out of synergistic patterns toward more isolated movements. Movement quality of the affected UE is compared to the non-affected UE on 0-2 ordinal scale with 0 indicating no movement at all, 1 indicating partial movement of the affected extremity, and 2 indicating movement equivalent to the non-affected UEs. The score ranges from 0-to-66. |
| Time Frame | End of Treatment at 8 weeks post enrolment |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Hand Mentor Therapy | Control |
|---|---|---|
| Arm/Group Description | Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance. | Self administered home therapy program Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program |
| Measure Participants | 51 | 48 |
| Mean (Standard Deviation) [units on a scale] |
43.43
(15.64)
|
42.89
(14.58)
|
| Title | Stroke Impact Scale (SIS) |
|---|---|
| Description | Quality of Life changes are measured with the Stroke Impact Scale questionnaire. The SIS is a self-rated QOL questionnaire that addresses several domains following stroke: physical strength, memory, feelings and emotions, communication, activities of daily living (ADL), mobility, hand use, meaningful activities, and overall percentage recovery from the stroke. We report the Hand Function subscale, which ranges from 0-to-100. A higher score reflects better hand function. |
| Time Frame | End of treatment at 8 weeks post enrolment |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Hand Mentor Therapy | Control |
|---|---|---|
| Arm/Group Description | Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance. | Self administered home therapy program Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program |
| Measure Participants | 51 | 48 |
| Mean (Standard Deviation) [units on a scale] |
49.4
(33.5)
|
57.6
(28.2)
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Hand Mentor Therapy | Control | ||
| Arm/Group Description | Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance. | Self administered home therapy program Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program | ||
All Cause Mortality |
||||
| Hand Mentor Therapy | Control | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Hand Mentor Therapy | Control | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/51 (0%) | 0/48 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Hand Mentor Therapy | Control | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/51 (11.8%) | 5/48 (10.4%) | ||
| Gastrointestinal disorders | ||||
| Ulcer | 1/51 (2%) | 1 | 0/48 (0%) | 0 |
| General disorders | ||||
| Lost balance and fell | 3/51 (5.9%) | 3 | 5/48 (10.4%) | 5 |
| Psychiatric disorders | ||||
| Depression | 1/51 (2%) | 1 | 0/48 (0%) | 0 |
| Vascular disorders | ||||
| Recurrent stroke | 1/51 (2%) | 1 | 0/48 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | James Koeneman, PhD |
|---|---|
| Organization | Kinetic Muscles |
| Phone | 602-677-5256 |
| jimkoeneman509@gmail.com |
- NS070646
- 1RC3NS070646-01