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

NCT ID: NCT02360488

Last Updated: 2020-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2018-04-30

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.

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Telerehabilitation Therapy

Intervention Type: DEVICE

18 days of supervised sessions via videoconference and 18 days of unsupervised sessions.

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.

Group Type: ACTIVE_COMPARATOR

In-Clinic Therapy

Intervention Type: BEHAVIORAL

18 days of therapist supervised sessions and 18 days of unsupervised in home sessions.

Interventions

Telerehabilitation Therapy

18 days of supervised sessions via videoconference and 18 days of unsupervised sessions.

Intervention Type: DEVICE

In-Clinic Therapy

18 days of therapist supervised sessions and 18 days of unsupervised in home sessions.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Irvine

OTHER

Sponsor Role: lead

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)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven C Cramer, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

University of California, Irvine

Irvine, California, United States

UCSD Stroke Center

San Diego, California, United States

Brooks Rehabilitation Clinical Research Center

Jacksonville, Florida, United States

Emory Rehabilitation Hospital

Atlanta, Georgia, United States

Rehabilitation Institute of Chicago

Chicago, Illinois, United States

Spaulding Rehabilitation Hospital

Charlestown, Massachusetts, United States

Kessler Institute for Rehabilitation

Saddle Brook, New Jersey, United States

Mount Sinai

New York, New York, United States

Burke Rehabilitation Hospital

White Plains, New York, United States

MetroHealth Rehabilitation Institute of Ohio

Cleveland, Ohio, United States

MUSC Center for Rehabilitation Research in Neurological Conditions

Charleston, South Carolina, United States

Harborview Medical Center

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21482550 (View on PubMed)

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).

Reference Type: BACKGROUND

PMID: 18230848 (View on PubMed)

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. doi: 10.1016/S0140-6736(98)09477-X.

Reference Type: BACKGROUND

PMID: 10421300 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19608100 (View on PubMed)

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. No abstract available.

Reference Type: BACKGROUND

PMID: 21790271 (View on PubMed)

Cramer SC, Le V, Saver JL, Dodakian L, See J, Augsburger R, McKenzie A, Zhou RJ, Chiu NL, Heckhausen J, Cassidy JM, Scacchi W, Smith MT, Barrett AM, Knutson J, Edwards D, Putrino D, Agrawal K, Ngo K, Roth EJ, Tirschwell DL, Woodbury ML, Zafonte R, Zhao W, Spilker J, Wolf SL, Broderick JP, Janis S. Intense Arm Rehabilitation Therapy Improves the Modified Rankin Scale Score: Association Between Gains in Impairment and Function. Neurology. 2021 Apr 6;96(14):e1812-e1822. doi: 10.1212/WNL.0000000000011667. Epub 2021 Feb 15.

Reference Type: DERIVED

PMID: 33589538 (View on PubMed)

Cramer SC, Dodakian L, Le V, See J, Augsburger R, McKenzie A, Zhou RJ, Chiu NL, Heckhausen J, Cassidy JM, Scacchi W, Smith MT, Barrett AM, Knutson J, Edwards D, Putrino D, Agrawal K, Ngo K, Roth EJ, Tirschwell DL, Woodbury ML, Zafonte R, Zhao W, Spilker J, Wolf SL, Broderick JP, Janis S; National Institutes of Health StrokeNet Telerehab Investigators. Efficacy of Home-Based Telerehabilitation vs In-Clinic Therapy for Adults After Stroke: A Randomized Clinical Trial. JAMA Neurol. 2019 Sep 1;76(9):1079-1087. doi: 10.1001/jamaneurol.2019.1604.

Reference Type: DERIVED

PMID: 31233135 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

1U01NS091951-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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