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

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ClinicalTrials.gov Identifier: NCT02360488
Recruitment Status : Active, not recruiting
First Posted : February 10, 2015
Last Update Posted : February 6, 2018
Sponsor:
Information provided by (Responsible Party):
Steven C. Cramer, MD, University of California, Irvine

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 Type : Interventional  (Clinical Trial)
Estimated 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 : September 2015
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

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.




Primary Outcome Measures :
  1. arm motor Fugl-Meyer (FM) score [ Time Frame: from the Baseline Visit to the 30 Day Follow Up Visit ]
    Evaluates and measures arm motor recovery in post-stroke hemiplegic patients


Secondary Outcome Measures :
  1. Box and Block Test [ Time Frame: from the Screening Visit to the 30 Day Follow Up Visit ]
    Assesses unilateral gross manual dexterity

  2. Stroke Impact Scale-Hand Domain [ Time Frame: from the Baseline Visit to the 30 Day Follow Up Visit ]
    Assesses arm function status following stroke



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02360488


Locations
United States, California
University of California, Irvine
Irvine, California, United States, 92697
UCSD Stroke Center
San Diego, California, United States, 92103
United States, Florida
Brooks Rehabilitation Clinical Research Center
Jacksonville, Florida, United States, 32216
United States, Georgia
Emory Rehabilitation Hospital
Atlanta, Georgia, United States, 30322
United States, Illinois
Rehabilitation Institute of Chicago
Chicago, Illinois, United States, 60611
United States, Massachusetts
Spaulding Rehabilitation Hospital
Charlestown, Massachusetts, United States, 02129
United States, New Jersey
Kessler Institute for Rehabilitation
Saddle Brook, New Jersey, United States, 07663
United States, New York
Mount Sinai
New York, New York, United States, 10029
Burke Rehabilitation Hospital
White Plains, New York, United States, 10605
United States, Ohio
MetroHealth Rehabilitation Institute of Ohio
Cleveland, Ohio, United States, 44109
United States, South Carolina
MUSC Center for Rehabilitation Research in Neurological Conditions
Charleston, South Carolina, United States, 29425
United States, Washington
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

Publications:
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     History of Changes
Other Study ID Numbers: 1U01NS091951-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 10, 2015    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases