Telerehabilitation in the Home Versus Therapy In-Clinic for Patients With Stroke

• Sponsor: University of California, Irvine (Other)
• Overall Status: Completed
• CT.gov ID: NCT02360488
• Collaborator: (none)
• Enrollment: 124
• Locations: 12
• Arms: 2
• Duration (Months): 31
• Patients Per Site: 10.3
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The current study will test the effectiveness of a novel home-based telehealth system designed to improve motor recovery and patient education after stroke. A total of 124 subjects (the number may be larger depending on the rate of subject dropout) with arm motor deficits 4-36 weeks after a stroke due to ischemia or to intracerebral hemorrhage will be randomized to receive 6 weeks of intensive arm motor therapy (a) in a traditional in-clinic setting or (b) via in-home telerehabilitation (rehabilitation services delivered to the subject's home via an internet-connected computer). The intensity, duration, and frequency of this therapy will be identical across the two groups, with subjects in both treatment arms receiving 36 sessions (18 supervised and 18 unsupervised), 80 minutes each (including a 10 minute break), over 6 weeks. The primary endpoint is within-subject change in the arm motor Fugl-Meyer (FM) score from the Baseline Visit to 30 Day Follow-Up Visit. Arm motor status is the focus here because it is commonly affected by stroke, is of central importance to many human functions, and is strongly linked to disability and well being after stroke.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Device: Telerehabilitation Therapy; Behavioral: In-Clinic Therapy	Phase 1

Detailed Description

Substantial evidence indicates that occupational and physical therapy improves outcomes after stroke, and that larger doses are associated with superior outcomes. However, many patients receive suboptimal doses of therapy for reasons that include cost, access, and difficulty with travel. This problem is likely to increase with time given the aging of the population and the increased rate with which patients survive stroke. Telehealth, defined as the delivery of health-related services and information via telecommunication technologies, has enormous potential to address this unmet need.

The current study will test the effectiveness of a novel home-based telehealth system designed to improve motor recovery and patient education after stroke. A total of 124 subjects (the number may be larger depending on the rate of subject dropout) with arm motor deficits 4-36 weeks after a stroke due to ischemia or to intracerebral hemorrhage will be randomized to receive 6 weeks of intensive arm motor therapy (a) in a traditional in-clinic setting or (b) via in-home telerehabilitation (rehabilitation services delivered to the subject's home via an internet-connected computer). The intensity, duration, and frequency of this therapy will be identical across the two groups, with subjects in both treatment arms receiving 36 sessions (18 supervised and 18 unsupervised), 80 minutes each (including a 10 minute break), over 6 weeks. The primary endpoint is within-subject change in the arm motor Fugl-Meyer (FM) score from the Baseline Visit to 30 Day Follow-Up Visit. Arm motor status is the focus here because it is commonly affected by stroke, is of central importance to many human functions, and is strongly linked to disability and well being after stroke.

Telerehabilitation will be evaluated using an assessor-blind, randomized, non-inferiority study design. This study seeks to establish comparable efficacy between the two treatment arms based upon a non-inferiority margin of 2.05 points on the arm motor Fugl-Meyer scale. Key study features include enrollment of a diverse stroke population, standardized and blinded outcomes assessment, a standardized treatment protocol, covariate-adaptive randomization, and use of an active comparator that is matched for duration, frequency, and intensity of therapy. The FDA has determined that this investigation is a non-significant risk device study.

A minimum of 5 clinical sites will participate in this study. Each clinical site will conduct all testing and treatment at a single central site, although each clinical site is encouraged to recruit subjects from their referral hospitals. At the central study site, an Assessment Therapist will perform all study testing, blinded to treatment assignment (the subject by necessity is not blinded), while a Treatment Therapist will provide in-clinic therapy as well as direct home-based telerehabilitation. Potential enrollees may be identified through any of several routes, for example, during the acute stroke admission at the clinical site or a referral hospital, during inpatient rehabilitation at the clinical site or a referral hospital, or through other means of community-based recruitment. Study conduct will be highly standardized, including selecting therapy content, delivering therapy, and testing.

The current study aims to critically evaluate the utility of a telehealth approach to motor therapy and stroke education. Telehealth has enormous potential to address unmet needs in the growing population of stroke survivors.

Study Design

• Study Type: Interventional
• Actual Enrollment: 124 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Telerehabilitation in the Home Versus Therapy In-Clinic for Patients With Stroke An Assessor-blind, Randomized, Non-inferiority Trial
• Study Start Date: Sep 1, 2015
• Actual Primary Completion Date: Apr 1, 2018
• Actual Study Completion Date: Apr 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Telerehabilitation Therapy The Telerehabilitation arm of this study will deliver rehabilitation treatment sessions via an in-home internet-connected computer. A major component of the system is the use of games to promote therapeutically relevant movements. The subject will perform daily assigned home-based telerehabilitation games and exercises and 5 minutes of stroke education, all guided by the telerehabilitation system.During half of the sessions, therapists will initiate a videoconference with the subject's telerehabilitation system to discuss progress, issues, and revise treatment plans as needed.	Device: Telerehabilitation Therapy; 18 days of supervised sessions via videoconference and 18 days of unsupervised sessions.
Active Comparator: In-Clinic Therapy The in-clinic arm of this study will deliver half of the rehabilitation treatment sessions at a study site providing traditional outpatient therapy, continuously supervised by a licensed therapist. The unsupervised therapy sessions will take place in the patient's home, and will be guided by an individualized booklet generated and printed by the Treatment Therapist and distributed to the subject during the first in-clinic therapy visit. The content of the unsupervised therapy sessions will be matched to the same exercise and training components provided during the subject's in-clinic supervised therapy sessions. In addition, at the start of each of the unsupervised sessions, all subjects will receive 5 minutes of stroke education.	Behavioral: In-Clinic Therapy; 18 days of therapist supervised sessions and 18 days of unsupervised in home sessions.

Outcome Measures

Primary Outcome Measures

1. Change in Arm Motor Fugl-Meyer Score From Baseline to 30 Days Post-therapy [from the Baseline Visit to the 30 Day Follow Up Visit]

   The full name of this scale is the arm motor Fugl-Meyer scale. it measures arm motor impairment, which is in the body structure/function domain. It consists of 33 individual assessments that are summed to generate a total arm motor Fugl-Meyer score. Scores range from 0-66, which higher values being better (and so 66 being normal). There are no subscores evaluated.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria

1. Age ≥18 years at the time of randomization

2. Stroke that is radiologically verified, due to ischemia or to intracerebral hemorrhage, and with time of stroke onset 4-36 weeks prior to randomization

3. Arm motor FM score of 22-56 (out of 66) at both the Screening Visit and Baseline Visit

4. Box & Block Test score with affected arm is at least 3 blocks in 60 seconds at the Screening Visit

5. Informed consent signed by the subject

6. Behavioral contract signed by the subject

Exclusion criteria

1. A major, active, coexistent neurological or psychiatric disease, including alcoholism or dementia

2. A diagnosis (apart from the index stroke) that substantially affects paretic arm function

3. A major medical disorder that substantially reduces the likelihood that a subject will be able to comply with all study procedures

4. Severe depression, defined as GDS Score >10

5. Significant cognitive impairment, defined as Montreal Cognitive Assessment score < 22

6. Deficits in communication that interfere with reasonable study participation

7. A new symptomatic stroke has occurred since the index stroke that occurred 4-36 weeks prior to randomization

8. Lacking visual acuity, with or without corrective lens, of 20/40 or better in at least one eye

9. Life expectancy < 6 months

10. Pregnant

11. Receipt of Botox to arms, legs, or trunk in the preceding 6 months, or expectation that Botox will be administered to the arm, leg, or trunk prior to completion of the 30 Day Follow Up Visit

12. Unable to successfully perform all 3 of the rehabilitation exercise test examples

13. Unable or unwilling to perform study procedures/therapy, or expectation of non-compliance with study procedures/therapy

14. Concurrent enrollment in another investigational study

15. Non-English speaking, such that subject does not speak sufficient English to comply with study procedures

16. Expectation that subject cannot participate in study visits

17. Expectation that subject will not have a single domicile address during the 6 weeks of therapy, within 25 miles of the central study site and with Verizon wireless reception.**

• A site may enroll a person who does not meet exclusion criterion # 17 if this is specifically approved by the site's study PI.

• Because Montreal Cognitive Assessment scores may be difficult to interpret for patients with aphasia, at the discretion of the site's study PI, exclusion criterion #5 ("MoCA score cannot be <22") can be waived.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, Irvine	Irvine	California	United States	92697
2	UCSD Stroke Center	San Diego	California	United States	92103
3	Brooks Rehabilitation Clinical Research Center	Jacksonville	Florida	United States	32216
4	Emory Rehabilitation Hospital	Atlanta	Georgia	United States	30322
5	Rehabilitation Institute of Chicago	Chicago	Illinois	United States	60611
6	Spaulding Rehabilitation Hospital	Charlestown	Massachusetts	United States	02129
7	Kessler Institute for Rehabilitation	Saddle Brook	New Jersey	United States	07663
8	Mount Sinai	New York	New York	United States	10029
9	Burke Rehabilitation Hospital	White Plains	New York	United States	10605
10	MetroHealth Rehabilitation Institute of Ohio	Cleveland	Ohio	United States	44109
11	MUSC Center for Rehabilitation Research in Neurological Conditions	Charleston	South Carolina	United States	29425
12	Harborview Medical Center	Seattle	Washington	United States	98104

Sponsors and Collaborators

• University of California, Irvine

Investigators

• Principal Investigator: Steven C Cramer, MD, University of California, Irvine

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Apr 21, 2016

More Information

Publications

• Brennan DM, Tindall L, Theodoros D, Brown J, Campbell M, Christiana D, Smith D, Cason J, Lee A; American Telemedicine Association. A blueprint for telerehabilitation guidelines--October 2010. Telemed J E Health. 2011 Oct;17(8):662-5. doi: 10.1089/tmj.2011.0036. Epub 2011 Jul 26.
• Cramer SC, Sur M, Dobkin BH, O'Brien C, Sanger TD, Trojanowski JQ, Rumsey JM, Hicks R, Cameron J, Chen D, Chen WG, Cohen LG, deCharms C, Duffy CJ, Eden GF, Fetz EE, Filart R, Freund M, Grant SJ, Haber S, Kalivas PW, Kolb B, Kramer AF, Lynch M, Mayberg HS, McQuillen PS, Nitkin R, Pascual-Leone A, Reuter-Lorenz P, Schiff N, Sharma A, Shekim L, Stryker M, Sullivan EV, Vinogradov S. Harnessing neuroplasticity for clinical applications. Brain. 2011 Jun;134(Pt 6):1591-609. doi: 10.1093/brain/awr039. Epub 2011 Apr 10.
• Kleim JA, Jones TA. Principles of experience-dependent neural plasticity: implications for rehabilitation after brain damage. J Speech Lang Hear Res. 2008 Feb;51(1):S225-39. doi: 10.1044/1092-4388(2008/018).
• Kwakkel G, Wagenaar RC, Twisk JW, Lankhorst GJ, Koetsier JC. Intensity of leg and arm training after primary middle-cerebral-artery stroke: a randomised trial. Lancet. 1999 Jul 17;354(9174):191-6.
• Langhorne P, Coupar F, Pollock A. Motor recovery after stroke: a systematic review. Lancet Neurol. 2009 Aug;8(8):741-54. doi: 10.1016/S1474-4422(09)70150-4. Review.

• Responsible Party: Steven C. Cramer, MD, Professor of Neurology and Anatomy & Neurobiology; Vice Chair for Research in the Dept. Neurology, Clinical Director of the Stem Cell Research Center, Associate Director of the UC Irvine CTSA (Institute for Clinical & Translational Science), University of California, Irvine
• ClinicalTrials.gov Identifier: NCT02360488
• Other Study ID Numbers: 1U01NS091951-01A1
• First Posted: Feb 10, 2015
• Last Update Posted: Feb 28, 2020
• Last Verified: Feb 1, 2020

• Additional relevant MeSH terms: Stroke

Study Results

Participant Flow

Arm/Group Title	Telerehabilitation Therapy	In-Clinic Therapy
Arm/Group Description	The Telerehabilitation arm of this study will deliver rehabilitation treatment sessions via an in-home internet-connected computer. A major component of the system is the use of games to promote therapeutically relevant movements. The subject will perform daily assigned home-based telerehabilitation games and exercises and 5 minutes of stroke education, all guided by the telerehabilitation system.During half of the sessions, therapists will initiate a videoconference with the subject's telerehabilitation system to discuss progress, issues, and revise treatment plans as needed. Telerehabilitation Therapy: 18 days of supervised sessions via videoconference and 18 days of unsupervised sessions.	The in-clinic arm of this study will deliver half of the rehabilitation treatment sessions at a study site providing traditional outpatient therapy, continuously supervised by a licensed therapist. The unsupervised therapy sessions will take place in the patient's home, and will be guided by an individualized booklet generated and printed by the Treatment Therapist and distributed to the subject during the first in-clinic therapy visit. The content of the unsupervised therapy sessions will be matched to the same exercise and training components provided during the subject's in-clinic supervised therapy sessions. In addition, at the start of each of the unsupervised sessions, all subjects will receive 5 minutes of stroke education. In-Clinic Therapy: 18 days of therapist supervised sessions and 18 days of unsupervised in home sessions.
Period Title: Overall Study
STARTED	62	62
COMPLETED	59	55
NOT COMPLETED	3	7

Baseline Characteristics

Arm/Group Title	Telerehabilitation Therapy	In-Clinic Therapy	Total
Arm/Group Description	The Telerehabilitation arm of this study will deliver rehabilitation treatment sessions via an in-home internet-connected computer. A major component of the system is the use of games to promote therapeutically relevant movements. The subject will perform daily assigned home-based telerehabilitation games and exercises and 5 minutes of stroke education, all guided by the telerehabilitation system.During half of the sessions, therapists will initiate a videoconference with the subject's telerehabilitation system to discuss progress, issues, and revise treatment plans as needed. Telerehabilitation Therapy: 18 days of supervised sessions via videoconference and 18 days of unsupervised sessions.	The in-clinic arm of this study will deliver half of the rehabilitation treatment sessions at a study site providing traditional outpatient therapy, continuously supervised by a licensed therapist. The unsupervised therapy sessions will take place in the patient's home, and will be guided by an individualized booklet generated and printed by the Treatment Therapist and distributed to the subject during the first in-clinic therapy visit. The content of the unsupervised therapy sessions will be matched to the same exercise and training components provided during the subject's in-clinic supervised therapy sessions. In addition, at the start of each of the unsupervised sessions, all subjects will receive 5 minutes of stroke education. In-Clinic Therapy: 18 days of therapist supervised sessions and 18 days of unsupervised in home sessions.	Total of all reporting groups
Overall Participants	62	62	124
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62 (14)	60 (13)	61 (14)
Sex: Female, Male (Count of Participants)
Female	14 22.6%	20 32.3%	34 27.4%
Male	48 77.4%	42 67.7%	90 72.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 4.8%	0 0%	3 2.4%
Not Hispanic or Latino	59 95.2%	62 100%	121 97.6%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	6 9.7%	4 6.5%	10 8.1%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	15 24.2%	18 29%	33 26.6%
White	41 66.1%	39 62.9%	80 64.5%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	1 1.6%	1 0.8%
Region of Enrollment (participants) [Number]
United States	62 100%	62 100%	124 100%
Arm motor Fugl-Meyer score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	42.8 (7.8)	42.7 (8.7)	42.8 (8.3)

Outcome Measures

1. Primary Outcome

Title	Change in Arm Motor Fugl-Meyer Score From Baseline to 30 Days Post-therapy
Description	The full name of this scale is the arm motor Fugl-Meyer scale. it measures arm motor impairment, which is in the body structure/function domain. It consists of 33 individual assessments that are summed to generate a total arm motor Fugl-Meyer score. Scores range from 0-66, which higher values being better (and so 66 being normal). There are no subscores evaluated.
Time Frame	from the Baseline Visit to the 30 Day Follow Up Visit

Outcome Measure Data

Analysis Population Description

Intention-to-Treat with multiple imputation of missing outcomes

Arm/Group Title	Telerehabilitation Therapy	In-Clinic Therapy
Arm/Group Description	The Telerehabilitation arm of this study will deliver rehabilitation treatment sessions via an in-home internet-connected computer. A major component of the system is the use of games to promote therapeutically relevant movements. The subject will perform daily assigned home-based telerehabilitation games and exercises and 5 minutes of stroke education, all guided by the telerehabilitation system.During half of the sessions, therapists will initiate a videoconference with the subject's telerehabilitation system to discuss progress, issues, and revise treatment plans as needed. Telerehabilitation Therapy: 18 days of supervised sessions via videoconference and 18 days of unsupervised sessions.	The in-clinic arm of this study will deliver half of the rehabilitation treatment sessions at a study site providing traditional outpatient therapy, continuously supervised by a licensed therapist. The unsupervised therapy sessions will take place in the patient's home, and will be guided by an individualized booklet generated and printed by the Treatment Therapist and distributed to the subject during the first in-clinic therapy visit. The content of the unsupervised therapy sessions will be matched to the same exercise and training components provided during the subject's in-clinic supervised therapy sessions. In addition, at the start of each of the unsupervised sessions, all subjects will receive 5 minutes of stroke education. In-Clinic Therapy: 18 days of therapist supervised sessions and 18 days of unsupervised in home sessions.
Measure Participants	62	62
Mean (Standard Deviation) [units on a scale]	7.86 (6.68)	8.36 (7.04)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Telerehabilitation Therapy, In-Clinic Therapy
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	The trial aimed to establish comparable efficacy based upon a non-inferiority margin of 30% of the change in Fugl-Meyer score in the In-Clinic group. Under these assumptions at alpha=0.05 and assuming SD=3.8 points, 124 subjects would need to be enrolled to provide 85% power; this sample was pursued independent of subject dropouts.
Statistical Test of Hypothesis	p-Value	.96
	Comments
	Method	Regression, Linear
	Comments	The model was adjusted for study site, age, time post-stroke, stroke subtype, and baseline Fugl-Meyer score.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.06
	Confidence Interval	(2-Sided) 95%; -2.14 to 2.26
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Baseline to 30 days post-therapy
Adverse Event Reporting Description	Adverse events were collected, and those possibly or probably reasonably/definitely related to study procedures are reported.
Arm/Group Title	Telerehabilitation Therapy		In-Clinic Therapy
Arm/Group Description	The Telerehabilitation arm of this study will deliver rehabilitation treatment sessions via an in-home internet-connected computer. A major component of the system is the use of games to promote therapeutically relevant movements. The subject will perform daily assigned home-based telerehabilitation games and exercises and 5 minutes of stroke education, all guided by the telerehabilitation system.During half of the sessions, therapists will initiate a videoconference with the subject's telerehabilitation system to discuss progress, issues, and revise treatment plans as needed. Telerehabilitation Therapy: 18 days of supervised sessions via videoconference and 18 days of unsupervised sessions.		The in-clinic arm of this study will deliver half of the rehabilitation treatment sessions at a study site providing traditional outpatient therapy, continuously supervised by a licensed therapist. The unsupervised therapy sessions will take place in the patient's home, and will be guided by an individualized booklet generated and printed by the Treatment Therapist and distributed to the subject during the first in-clinic therapy visit. The content of the unsupervised therapy sessions will be matched to the same exercise and training components provided during the subject's in-clinic supervised therapy sessions. In addition, at the start of each of the unsupervised sessions, all subjects will receive 5 minutes of stroke education. In-Clinic Therapy: 18 days of therapist supervised sessions and 18 days of unsupervised in home sessions.
All Cause Mortality
	Telerehabilitation Therapy		In-Clinic Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/62 (0%)		0/62 (0%)
Serious Adverse Events
	Telerehabilitation Therapy		In-Clinic Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/62 (1.6%)		6/62 (9.7%)
Cardiac disorders
Dizziness	1/62 (1.6%)	1	0/62 (0%)	0
Hypertension	0/62 (0%)	0	1/62 (1.6%)	1
Ear and labyrinth disorders
Fall	0/62 (0%)	0	1/62 (1.6%)	1
Musculoskeletal and connective tissue disorders
Limb fracture	0/62 (0%)	0	1/62 (1.6%)	1
Nervous system disorders
Subdural hemorrhage	0/62 (0%)	0	1/62 (1.6%)	1
Respiratory, thoracic and mediastinal disorders
Pneumonia	0/62 (0%)	0	1/62 (1.6%)	1
Pleural effusion	0/62 (0%)	0	1/62 (1.6%)	1
Other (Not Including Serious) Adverse Events
	Telerehabilitation Therapy		In-Clinic Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/62 (16.1%)		7/62 (11.3%)
Cardiac disorders
Hypotension	0/62 (0%)	0	1/62 (1.6%)	1
Musculoskeletal and connective tissue disorders
Arm/shoulder pain	10/62 (16.1%)	10	4/62 (6.5%)	4
Fracture	0/62 (0%)	0	1/62 (1.6%)	1
Nervous system disorders
Fatigue	0/62 (0%)	0	1/62 (1.6%)	1

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.