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

Stroke Clinical Trial

Official title:

Telerehabilitation in the Home Versus Therapy In-Clinic for Patients With Stroke An Assessor-blind, Randomized, Non-inferiority Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02360488
• Other study ID #: 1U01NS091951-01A1
• Status: Completed
• Phase: Phase 1
• Start date: September 2015
• Est. completion date: April 2018

Study information

• Verified date: February 2020
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Telerehabilitation Therapy
18 days of supervised sessions via videoconference and 18 days of unsupervised sessions.

Behavioral:
• In-Clinic Therapy
18 days of therapist supervised sessions and 18 days of unsupervised in home sessions.

Locations

Country	Name	City	State
United States	Emory Rehabilitation Hospital	Atlanta	Georgia
United States	MUSC Center for Rehabilitation Research in Neurological Conditions	Charleston	South Carolina
United States	Spaulding Rehabilitation Hospital	Charlestown	Massachusetts
United States	Rehabilitation Institute of Chicago	Chicago	Illinois
United States	MetroHealth Rehabilitation Institute of Ohio	Cleveland	Ohio
United States	University of California, Irvine	Irvine	California
United States	Brooks Rehabilitation Clinical Research Center	Jacksonville	Florida
United States	Mount Sinai	New York	New York
United States	Kessler Institute for Rehabilitation	Saddle Brook	New Jersey
United States	UCSD Stroke Center	San Diego	California
United States	Harborview Medical Center	Seattle	Washington
United States	Burke Rehabilitation Hospital	White Plains	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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). — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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