Long-term Telerehabilitation for Patients With Stroke

Completed · Not applicable

Conditions studied: Stroke, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases

In brief

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.

Key facts

Study ID

NCT03460587

Run by

University of California, Irvine

People needed

13

Starts

2018-08-29

Expected to finish

2019-03-31

Last updated by the study team

2020-12-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of California, Irvine — Irvine, California, United States

Full record on ClinicalTrials.gov

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