Status:
COMPLETED
Long-term Telerehabilitation for Patients With Stroke
Lead Sponsor:
University of California, Irvine
Conditions:
Stroke
Cerebrovascular Disorders
Eligibility:
All Genders
18+ years
Phase:
NA
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) ...
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 ...
Eligibility Criteria
Inclusion
- Age ≥18 years at the time of randomization
- 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
- 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
- Box \& Block Test score with affected arm is at least 3 blocks in 60 seconds at the first visit
- Informed consent signed by the subject
- Behavioral contract signed by the subject
Exclusion
- 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 Geriatric Depression Scale Score \>11
- 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
- Deficits in communication that interfere with reasonable study participation
- Lacking visual acuity, with or without corrective lens, of 20/40 or better in at least one eye
- Life expectancy \< 6 months
- 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
- 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, or expectation that subject will be unable to participate in study visits
- 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 will not have a single domicile address during the 12 weeks of therapy, within 75 miles of the central study site
- 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.
Key Trial Info
Start Date :
August 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2019
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT03460587
Start Date
August 29 2018
End Date
March 31 2019
Last Update
December 17 2020
Active Locations (1)
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1
University of California, Irvine
Irvine, California, United States, 92697