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Long-term Telerehabilitation for Patients With Stroke

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ClinicalTrials.gov Identifier: NCT03460587
Recruitment Status : Completed
First Posted : March 9, 2018
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Steven C. Cramer, MD, University of California, Irvine

Brief Summary:

The aim of the current protocol is to study 40 patients, each for 12 weeks, to address hypotheses related to the ability of a telerehabilitation system to (a) improve motor status and disability, (b) collect various forms of patient data from the home, (c) improve risk factor knowledge and control, and (d) assess patient compliance with home-based telerehabilitation.

Patients who have returned to their home after stroke will be provided with a telehealth system and be asked to use it 6 days/week for 12 weeks, during which time subjects will use this system for daily rehabilitation therapy, assessments, and education--all on one platform.


Condition or disease Intervention/treatment Phase
Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Device: Telerehabilitation Not Applicable

Detailed Description:

Stroke is perennially one of the leading causes of human disability. Stroke is truly a chronic disease, with survivors living for years or decades after the event. Increasing evidence describes years of steady decline in several health measures for stroke survivors. Many factors contribute to this, including further strokes, uncontrolled risk factors, development of late complications of stroke, and limited access to rehabilitation therapy.

New approaches are needed that address the many needs of stroke survivors, efficiently and in aggregate. Emerging telehealth technologies have high potential to address this major unmet need, but substantial innovation will be needed. The long-term goal is to establish a telehealth platform to treat chronic stroke.

A telehealth system will be delivered to enrollee's home. Patients will be asked to interact with their system daily (at least 6 days/wk) for 12 weeks. For 3 times per week, during the first 2 weeks, and then 1 time per week thereafter, a study therapist or research assistant in the lab will use the telehealth system to have a videoconference with the subject, to answer questions, provide feedback, review progress, and make any changes needed in the therapy plan. Study personnel will monitor usage statistics and performance measures for all systems.

A key strategy is to measure in parallel, patient behaviors in three categories of health issues central to chronic stroke: (1) medical management issues including risk factor knowledge and control, (2) disability issues including motor function, and (3) psychological issues including depression and anxiety.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-term Telerehabilitation for Patients With Stroke
Actual Study Start Date : August 29, 2018
Actual Primary Completion Date : March 31, 2019
Actual Study Completion Date : March 31, 2019

Arm Intervention/treatment
Experimental: Home-based Telerehabilitation
Home-based Telerehabilitation
Device: Telerehabilitation
The Telerehabilitation system 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 some of the sessions, therapists will initiate a videoconference with the subject's telerehabilitation system to discuss progress, issues, and revise treatment plans as needed.




Primary Outcome Measures :
  1. Fugl-Meyer arm motor scale [ Time Frame: 90 days ]
    measure of arm impairment, scores range from 0 to 66 with higher numbers reflecting less arm impairment


Secondary Outcome Measures :
  1. Stroke Prevention Knowledge [ Time Frame: 90 days ]
    knowledge about stroke prevention, scores range from 0 to 30 with higher numbers reflecting greater stroke prevention knowledge

  2. Fugl-Meyer leg motor scale [ Time Frame: 90 days ]
    measure of leg impairment, scores range from 0 to 34 with higher numbers reflecting less leg impairment



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 or subarachnoid hemorrhage, and with any time of stroke onset prior to randomization
  3. Arm motor Fugl Meyer score of 28-66; if Arm motor Fugl Meyer score> 59, must also have Box & Blocks on affected side >25% lower
  4. Box & Block Test score with affected arm is at least 3 blocks in 60 seconds at the first 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 Geriatric Depression Scale Score >11
  5. Significant cognitive impairment, defined as Montreal Cognitive Assessment score < 22; note that this exclusion criteria can be waived at the discretion of the study PI, e.g., for aphasia
  6. Deficits in communication that interfere with reasonable study participation
  7. Lacking visual acuity, with or without corrective lens, of 20/40 or better in at least one eye
  8. Life expectancy < 6 months
  9. 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 participation in this study
  10. Unable to successfully perform all 3 of the rehabilitation exercise test examples
  11. Unable or unwilling to perform study procedures/therapy, or expectation of non-compliance with study procedures/therapy, or expectation that subject will be unable to participate in study visits
  12. Concurrent enrollment in another investigational study
  13. Non-English speaking, such that subject does not speak sufficient English to comply with study procedures
  14. Expectation that subject will not have a single domicile address during the 12 weeks of therapy, within 75 miles of the central study site
  15. Note that the presence of wireless home internet connectivity is not an exclusion criterion, but preference may be given to enrollees who do have wireless home internet connectivity because this will enable testing of study hypotheses.

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): NCT03460587


Locations
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United States, California
University of California, Irvine
Irvine, California, United States, 92697
Sponsors and Collaborators
University of California, Irvine
Investigators
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Principal Investigator: Steven Cramer, MD UC Irvine

Publications:
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Responsible Party: Steven C. Cramer, MD, Professor of Neurology, University of California, Irvine
ClinicalTrials.gov Identifier: NCT03460587     History of Changes
Other Study ID Numbers: 17IRG3346039
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Brain Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Vascular Diseases
Nervous System Diseases
Cardiovascular Diseases