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

Primary Purpose

Stroke

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Telerehabilitation Therapy
In-Clinic Therapy
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California, Irvine
  • UCSD Stroke Center
  • Brooks Rehabilitation Clinical Research Center
  • Emory Rehabilitation Hospital
  • Rehabilitation Institute of Chicago
  • Spaulding Rehabilitation Hospital
  • Kessler Institute for Rehabilitation
  • Mount Sinai
  • Burke Rehabilitation Hospital
  • MetroHealth Rehabilitation Institute of Ohio
  • MUSC Center for Rehabilitation Research in Neurological Conditions
  • Harborview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telerehabilitation Therapy

In-Clinic Therapy

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 5, 2015
Last Updated
February 17, 2020
Sponsor
University of California, Irvine
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1. Study Identification

Unique Protocol Identification Number
NCT02360488
Brief Title
Telerehabilitation in the Home Versus Therapy In-Clinic for Patients With Stroke
Official Title
Telerehabilitation in the Home Versus Therapy In-Clinic for Patients With Stroke An Assessor-blind, Randomized, Non-inferiority Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telerehabilitation Therapy
Arm Type
Experimental
Arm 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.
Arm Title
In-Clinic Therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Telerehabilitation Therapy
Intervention Description
18 days of supervised sessions via videoconference and 18 days of unsupervised sessions.
Intervention Type
Behavioral
Intervention Name(s)
In-Clinic Therapy
Intervention Description
18 days of therapist supervised sessions and 18 days of unsupervised in home sessions.
Primary Outcome Measure Information:
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria 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 Exclusion criteria 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 Expectation that subject cannot participate in study visits 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven C Cramer, MD
Organizational Affiliation
University of California, Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
UCSD Stroke Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Brooks Rehabilitation Clinical Research Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Emory Rehabilitation Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Rehabilitation Institute of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Spaulding Rehabilitation Hospital
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
Facility Name
Kessler Institute for Rehabilitation
City
Saddle Brook
State/Province
New Jersey
ZIP/Postal Code
07663
Country
United States
Facility Name
Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Burke Rehabilitation Hospital
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States
Facility Name
MetroHealth Rehabilitation Institute of Ohio
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
MUSC Center for Rehabilitation Research in Neurological Conditions
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21482550
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.
Results Reference
background
PubMed Identifier
18230848
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).
Results Reference
background
PubMed Identifier
10421300
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. doi: 10.1016/S0140-6736(98)09477-X.
Results Reference
background
PubMed Identifier
19608100
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.
Results Reference
background
PubMed Identifier
21790271
Citation
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.
Results Reference
background
PubMed Identifier
33589538
Citation
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.
Results Reference
derived
PubMed Identifier
31233135
Citation
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.
Results Reference
derived

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

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