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

NCT02360488 | Completed Phase 1 Results

• 1 other identifier: 1U01NS091951-01A1
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 12

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Change in Arm Motor Fugl-Meyer Score From Baseline to 30 Days Post-therapy

  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.

  from the Baseline Visit to the 30 Day Follow Up Visit

Study Arms (2)

Telerehabilitation Therapy

EXPERIMENTAL

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

In-Clinic Therapy

ACTIVE COMPARATOR

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

Interventions

Telerehabilitation Therapy DEVICE

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

Telerehabilitation Therapy

In-Clinic Therapy BEHAVIORAL

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

In-Clinic Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years at the time of randomization
• Stroke that is radiologically verified, due to ischemia or to intracerebral hemorrhage, and with time of stroke onset 4-36 weeks prior to randomization
• Arm motor FM score of 22-56 (out of 66) at both the Screening Visit and Baseline Visit
• Box \& Block Test score with affected arm is at least 3 blocks in 60 seconds at the Screening Visit
• Informed consent signed by the subject
• Behavioral contract signed by the subject

You may not qualify if:

• A major, active, coexistent neurological or psychiatric disease, including alcoholism or dementia
• A diagnosis (apart from the index stroke) that substantially affects paretic arm function
• A major medical disorder that substantially reduces the likelihood that a subject will be able to comply with all study procedures
• Severe depression, defined as GDS Score \>10
• Significant cognitive impairment, defined as Montreal Cognitive Assessment score \< 22
• Deficits in communication that interfere with reasonable study participation
• A new symptomatic stroke has occurred since the index stroke that occurred 4-36 weeks prior to randomization
• Lacking visual acuity, with or without corrective lens, of 20/40 or better in at least one eye
• Life expectancy \< 6 months
• Pregnant
• 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
• Unable to successfully perform all 3 of the rehabilitation exercise test examples
• Unable or unwilling to perform study procedures/therapy, or expectation of non-compliance with study procedures/therapy
• Concurrent enrollment in another investigational study
• Non-English speaking, such that subject does not speak sufficient English to comply with study procedures

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (12)

University of California, Irvine

Irvine, California, 92697, United States

Location

UCSD Stroke Center

San Diego, California, 92103, United States

Location

Brooks Rehabilitation Clinical Research Center

Jacksonville, Florida, 32216, United States

Location

Emory Rehabilitation Hospital

Atlanta, Georgia, 30322, United States

Location

Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

Location

Spaulding Rehabilitation Hospital

Charlestown, Massachusetts, 02129, United States

Location

Kessler Institute for Rehabilitation

Saddle Brook, New Jersey, 07663, United States

Location

Mount Sinai

New York, New York, 10029, United States

Location

Burke Rehabilitation Hospital

White Plains, New York, 10605, United States

Location

MetroHealth Rehabilitation Institute of Ohio

Cleveland, Ohio, 44109, United States

Location

MUSC Center for Rehabilitation Research in Neurological Conditions

Charleston, South Carolina, 29425, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Related Publications (7)

• 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.

  PMID: 21482550 BACKGROUND

• 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).

  PMID: 18230848 BACKGROUND

• 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.

  PMID: 10421300 BACKGROUND

• 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.

  PMID: 19608100 BACKGROUND

• 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.

  PMID: 21790271 BACKGROUND

• 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.

  PMID: 33589538 DERIVED

• 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.

  PMID: 31233135 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Steve Cramer
• Organization: UCLA

sccramer@mednet.ucla.edu

424-522-7273

Study Officials

• Steven C Cramer, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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)

Study Record Dates

• First Submitted: February 5, 2015
• First Posted: February 10, 2015
• Study Start: September 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: February 28, 2020
• Results First Posted: February 28, 2020

Record last verified: 2020-02

Locations

US (12)