Telerehabilitation in the home versus therapy in-clinic for patients with stroke
Dr. Steven Cramer
UC Irvine campus; UC Irvine School of Medicine.
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 minimum 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 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, over 6 weeks. The primary endpoint is within-subject change in the arm motor Fugl-Meyer (FM) score from the Baseline exam to 30 day follow up.
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.
- Age ≥ 18 years at the time of randomization
- Ischemic or hemorrhagic stroke that is radiologically verified, with time of stroke onset 4-36 weeks prior to randomization
- Arm motor FM score of 22-56 (out of 66) at the screening visit
- Box and block test score with affected arm is at least three blocks in 60 seconds at the screening visit
- Informed consent signed by the subject
- Behavioral contract signed by the subject
Arm motor function gains.