Status:
ACTIVE_NOT_RECRUITING
Telerehabilitation Early After CNS Injury
Lead Sponsor:
TRCare, Inc.
Collaborating Sponsors:
California Rehabilitation Institute
Conditions:
Cerebral Stroke
Traumatic Brain Injury
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
This clinical trial is designed to address 3 specific aims: Aim 1: To measure the safety of daily bedside telerehabilitation. Aim 2: To measure the feasibility of daily bedside telerehabilitation. ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06069999
Start Date
May 9 2024
End Date
October 30 2025
Last Update
August 29 2025
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
California Rehabilitation Institute
Los Angeles, California, United States, 90095
2
Casa Colina Hospital and Centers for Healthcare
Pomona, California, United States, 91769
3
Brooks Rehabilitation
Jacksonville, Florida, United States, 32216
4
Jefferson Moss-Magee Rehabilitation
Philadelphia, Pennsylvania, United States, 19102