The National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health, is looking for individuals to participate in clinical studies. Participating in clinical trials allows you to play an active role in research on the nature and causes of many disorders of the brain and nervous system, and to possibly help physician-scientists develop future treatments. The information below is designed to help you quickly learn about actively recruiting research studies for which you or someone you know may be eligible.

Description:

The purpose of this trial is to determine if a home-based telerehabilitation therapy system is as good as in-clinic rehabilitation in helping people recover from stroke. This trial also will discover if providing educational materials improves understanding of stroke prevention and risk factor control.

Occupational and physical rehabilitation therapies may help with stroke recovery. The amount of therapy a person receives may affect recovery. While larger amounts of therapy may work better, some people may not receive enough due to high costs, limited access, and difficulty with travel. Telehealth—which allows people to use the internet in their own homes to obtain healthcare from medical professionals—may help address these problems. Telerehabilitation, a type of telehealth, lets people use the internet to obtain rehabilitation therapy in their homes. Both groups will be assessed and regularly supervised by a licensed occupational or physical therapist. This trial will find out if in-home telerehabilitation is as effective as in-clinic rehabilitation in helping people recover from stroke.

Approximately 124 participants will be enrolled in this trial at 8 to 12 sites in the United States.  Participants will be randomized to receive 6 weeks of either in-clinic therapy or home-based telerehabilitation therapy. Both groups will receive 6 therapy sessions per week, for a total of 36 sessions. Each session will last approximately 80 minutes (including breaks).  Participants randomized to the telerehabilitation will have a telehealth system—including a laptop computer and table—delivered to their homes. Participants will remain in the study for 10-12 weeks.

Eligibility Criteria:

INCLUSION

  1. Age ≥18 years
  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 Fugl-Meyer (FM) score of 22-56 (out of 66) at 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

EXCLUSION

  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 (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 since the index stroke 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

Study Design:

Allocation: Randomized Intervention Model: Parallel Assignment Masking: Outcomes Assessor Primary Purpose: Treatment

Study Location:

United States