Telerehabilitation for recovery after brain and spinal injuries
Bedside Telerehabilitation Early After CNS Injury
This study tests if a new telerehabilitation program using a special training system can help patients recovering from strokes, brain injuries, and spinal cord injuries improve their movement and recovery while they are still in the hospital.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | TRCare, Inc. Industry-sponsored |
| Locations | 5 sites (Los Angeles, California and 4 other locations) |
| Trial ID | NCT06069999 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and feasibility of a telerehabilitation program for patients recovering from recent strokes, traumatic brain injuries, and spinal cord injuries. Participants will engage in daily rehabilitation sessions using a sensor-based training system called HandyMotion, which allows them to access therapy exercises and games directly from their hospital room. The study will assess the effectiveness of this approach in improving motor function and overall rehabilitation outcomes during the inpatient recovery period.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who have experienced a CNS injury within the last 90 days and have specific motor deficits in at least one arm.
Not a fit: Patients with very mild or severe motor deficits, or those who cannot follow simple instructions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance recovery outcomes for patients with CNS injuries by providing more accessible and engaging rehabilitation therapy.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in using telerehabilitation for rehabilitation purposes, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18 years or older 2. CNS injury with onset in the prior 90 days 1. For stroke: Stroke that is radiologically verified and due to ischemia or to intracerebral hemorrhage. 2. 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. 3. For spinal cord injury: Traumatic or nontraumatic, incomplete cervical SCI. 3. 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. 4. 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. 5. Informed consent signed by the subject (no surrogate consent permitted for this study) 6. Able to follow simple instructions 7. Study participation is not likely to be significantly limited by agitated behavior Exclusion Criteria: 1. A major, active, coexistent neurological or psychiatric disease that would limit study participation, e.g., advanced dementia or active psychosis 2. Expectation that patient's cognitive status will likely interfere substantially with playing assigned games or exercises 3. Deficits in communication that interfere with reasonable study participation 4. Lacking visual acuity, with or without corrective lens, of 20/50 or better in at least one eye 5. Subject does not speak sufficient English to comply with study procedures 6. Shoulder pain that in the judgement of the study team is likely to substantially limit the amount of TR therapy completed
Where this trial is running
Los Angeles, California and 4 other locations
- California Rehabilitation Institute — Los Angeles, California, United States (Recruiting)
- Casa Colina Hospital and Centers for Healthcare — Pomona, California, United States (Recruiting)
- Brooks Rehabilitation — Jacksonville, Florida, United States (Recruiting)
- Jefferson Moss-Magee Rehabilitation — Philadelphia, Pennsylvania, United States (Recruiting)
- University of Utah - Craig H. Neilsen Rehabilitation Hospital — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Principal investigator: Michael Su, MD — California Rehabilitation Institute
- Study coordinator: Johnson K Sun
- Email: kit@trcare.net
- Phone: 650-300-2168
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.