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

This study is currently recruiting participants.
Verified August 2017 by Steven C. Cramer, MD, University of California, Irvine
Sponsor:
ClinicalTrials.gov Identifier:
NCT02360488
First Posted: February 10, 2015
Last Update Posted: August 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Steven C. Cramer, MD, University of California, Irvine
  Purpose
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 Intervention Phase
Stroke Device: Telerehabilitation Therapy Behavioral: In-Clinic Therapy Phase 1

Study Type: Interventional
Study Design: 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

Further study details as provided by Steven C. Cramer, MD, University of California, Irvine:

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

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


Estimated Enrollment: 124
Study Start Date: September 2015
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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


Contacts
Contact: Lucy Dodakian, MA, OTR/L 949-824-8748 telerehab@uci.edu

Locations
United States, California
University of California, Irvine Recruiting
Irvine, California, United States, 92697
Contact: Lucy Dodakian, MA, OTR/L    949-824-8748    telerehab@uci.edu   
Contact: Robert Zhou, BA    949-824-6032    telerehab@uci.edu   
Principal Investigator: Steven C Cramer, MD         
UCSD Stroke Center Recruiting
San Diego, California, United States, 92103
Contact: Karen Rapp    858-657-7182    krapp@ucsd.edu   
Principal Investigator: Brett Meyer, MD         
United States, Florida
Brooks Rehabilitation Clinical Research Center Recruiting
Jacksonville, Florida, United States, 32216
Contact: Taisiya Matev    904-345-8973    Taisiya.matev@brooksrehab.org   
Principal Investigator: Kenneth Ngo, MD         
United States, Georgia
Emory Rehabilitation Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Aimee Reiss, PT, DPT, NCS    404-712-8685    aimee.reiss@emory.edu   
Principal Investigator: Steven L Wolf, PhD         
United States, Illinois
Rehabilitation Institute of Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Theresa Ramirez    312-238-1657    tramirez@ric.org   
Principal Investigator: Elliot J Roth, MD         
United States, Massachusetts
Spaulding Rehabilitation Hospital Recruiting
Charlestown, Massachusetts, United States, 02129
Contact: Iris Monge    617-952-6193    imonge@partners.org   
Principal Investigator: Ross ZaFonte, DO         
United States, New Jersey
Kessler Institute for Rehabilitation Recruiting
Saddle Brook, New Jersey, United States, 07663
Contact: Gretchen March, OTR       gmarch@kessler-rehab.com   
Principal Investigator: A. M. Barrett, MD         
United States, New York
Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Ricardo Renvill    212-241-2220    ricardo.renvill@mssm.edu   
Contact: Jacob Greisman    212-241-4886    jacob.greisman@mountsinai.org   
Principal Investigator: Stanley Tuhrim, MD         
Burke Rehabilitation Hospital Recruiting
White Plains, New York, United States, 10605
Contact: Zoe Tsagaris, MS, OTR/L    914-597-2153    kzt3001@med.cornell.edu   
Principal Investigator: Dylan J Edwards, Ph.D., P.T.         
United States, Ohio
MetroHealth Rehabilitation Institute of Ohio Recruiting
Cleveland, Ohio, United States, 44109
Contact: Peggy Maloney, RN    216-957-3558    mmaloney@metrohealth.org   
Contact: Greg Naples       ggn@case.edu   
Principal Investigator: John Chae, MD, ME         
United States, South Carolina
MUSC Center for Rehabilitation Research in Neurological Conditions Recruiting
Charleston, South Carolina, United States, 29425
Contact: Michelle L Woodbury, PhD, OTR/L       WoodbuML@musc.edu   
Principal Investigator: Michelle L Woodbury, PhD, OTR/L         
United States, Washington
Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: Pat Tanzi, BSN, RN    206-744-3938    ptanzi@uw.edu   
Principal Investigator: David Tirschwell, MD         
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Steven C Cramer, MD University of California, Irvine
  More Information

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 Submitted: February 5, 2015
First Posted: February 10, 2015
Last Update Posted: August 14, 2017
Last Verified: August 2017

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