Telerehabilitation Early After CNS Injury (NCT06069999) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Telerehabilitation Early After CNS Injury
United States60 participantsStarted 2024-05-09
Plain-language summary
The goal of this clinical trial is to assess the safety and feasibility of providing extra doses of rehabilitation therapy for persons with a recent stroke, traumatic brain injury (TBI) and/or spinal cord injury (SCI). The therapy treatment targets to improve arm function by introducing telerehabilitation to the bedside of participants during the inpatient rehab admission period. Participants will use a newly developed functional training system (HandyMotion) to access therapy treatment program directly from their hospital room. HandyMotion is a sensor-based training system that can connect to the TV set in the hospital room, enabling patients to access their therapy training program to practice rehab-oriented games and exercises ad libitum, at any time of the day.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age 18 years or older
✓. CNS injury with onset in the prior 90 days
✓. For stroke: Stroke that is radiologically verified and due to ischemia or to intracerebral hemorrhage.
✓. For traumatic brain injury: History that is consistent with TBI; and score on the Revised Rancho Levels of Cognitive Functioning Scale is at least 6 out of 10.
✓. For spinal cord injury: Traumatic or nontraumatic, incomplete cervical SCI.
✓. At least one arm must have motor deficits that are neither very mild nor devastating (dense arm plegia). Operationally, this requires that the Visit 1 Box \& Block Test score is at least 1 block, but no more than 30 blocks, in 60 seconds.
✓. Possess enough arm movement to participate in therapy, including able to hold the HandyMotion device in the paretic hand(s), using an assistive device if needed.
✓. Informed consent signed by the subject (no surrogate consent permitted for this study)
Exclusion criteria
What they're measuring
1
Safety of daily beside telerehabilitation based on incidence of treatment-emergent adverse events as assessed by regular review of the medical record and patient interview
Timeframe: "For approximately 4 weeks, up until discharge"