Telerehabilitation Early After CNS Injury
Running, not enrolling · Not applicable
Conditions studied: Cerebral Stroke, Traumatic Brain Injury, Spinal Cord Injuries
In brief
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.
Key facts
- Study ID
- NCT06069999
- Run by
- TRCare, Inc.
- People needed
- 60
- Starts
- 2024-05-09
- Expected to finish
- 2025-10-30
- Last updated by the study team
- 2025-08-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
- Able to follow simple instructions
- Study participation is not likely to be significantly limited by agitated behavior
You may not qualify if…
- A major, active, coexistent neurological or psychiatric disease that would limit study participation, e.g., advanced dementia or active psychosis
- Expectation that patient's cognitive status will likely interfere substantially with playing assigned games or exercises
- Deficits in communication that interfere with reasonable study participation
- Lacking visual acuity, with or without corrective lens, of 20/50 or better in at least one eye
- Subject does not speak sufficient English to comply with study procedures
- Shoulder pain that in the judgement of the study team is likely to substantially limit the amount of TR therapy completed
Where it is running
- California Rehabilitation Institute — Los Angeles, California, United States
- Casa Colina Hospital and Centers for Healthcare — Pomona, California, United States
- Brooks Rehabilitation — Jacksonville, Florida, United States
- Jefferson Moss-Magee Rehabilitation — Philadelphia, Pennsylvania, United States
- University of Utah - Craig H. Neilsen Rehabilitation Hospital — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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