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Search / Trial NCT06069999

Telerehabilitation Early After CNS Injury

Launched by TRCARE, INC. · Oct 3, 2023

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

Stroke Traumatic Brain Injuries Spinal Cord Injuries Telerehabilitation Brain Plasticity Telehealth

ClinConnect Summary

This clinical trial is exploring a new way to help people recover from serious injuries to the brain or spinal cord, such as strokes, traumatic brain injuries (TBI), and spinal cord injuries (SCI). The focus is on using a system called HandyMotion, which allows patients to participate in rehabilitation exercises and games right from their hospital room, using a TV screen. This extra therapy aims to improve arm function during their stay in the hospital. The trial is currently looking for adult participants who have had a central nervous system injury within the last 90 days and have some movement in at least one arm to join the study.

Participants in this trial can expect to engage in fun, interactive training that they can do whenever they want during their hospital stay. To be eligible, you need to be at least 18 years old, have had a qualifying injury, and be able to follow simple instructions. It's important to note that individuals with certain serious health conditions or severe cognitive issues may not qualify for this study. Overall, this trial aims to make rehabilitation more accessible and effective for those recovering from significant injuries.

Gender

ALL

Eligibility 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

About Trcare, Inc.

trcare, inc. is a pioneering clinical trial sponsor dedicated to advancing medical research and enhancing patient outcomes through innovative therapeutic solutions. With a focus on oncology and rare diseases, trcare, inc. collaborates with leading researchers and institutions to design and implement robust clinical trials that prioritize patient safety and scientific integrity. Committed to leveraging cutting-edge technology and data analytics, the company aims to streamline trial processes and accelerate the development of effective treatments, ultimately improving the quality of life for patients worldwide.

Locations

Jacksonville, Florida, United States

Pomona, California, United States

Los Angeles, California, United States

Salt Lake City, Utah, United States

Philadelphia, Pennsylvania, United States

Patients applied

0 patients applied

Trial Officials

Michael Su, MD

Principal Investigator

California Rehabilitation Institute

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported