Telerehabilitation Early After CNS Injury

NCT06069999 | Active Not Recruiting FDA Device

• 1 other identifier: TRC-09
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

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 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.

Conditions

Cerebral Stroke; Traumatic Brain Injury; Spinal Cord Injuries

Keywords

Stroke; Traumatic Brain Injuries; Spinal Cord Injuries; Telerehabilitation; Brain Plasticity; Telehealth

Outcome Measures

Primary Outcomes (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

  Safety will be measured in terms of adverse events (AEs) deemed related to use of the telerehabilitation system on a probable or definite basis.

  "For approximately 4 weeks, up until discharge"

Secondary Outcomes (2)

• Feasibility of daily bedside telerehabilitation based on measurement of patient compliance, as determined by reviewing electronic records of device usage

  "baseline" and "immediately after end of treatment"

• Box and Blocks Test

  "baseline" and "immediately after end of treatment"

Study Arms (1)

TR Bedside Telerehabilitation

EXPERIMENTAL

Participants will be assigned 45-minutes of therapy training exercises each day for 7 days a week up to 4 weeks or until discharge. Participants will use the HandyMotion device to interact with the telerehabilitation program displayed on the TV set in the patient room.

Device: HandyMotion Treatment Program

Interventions

HandyMotion Treatment Program DEVICE

A pair of sensor-based wireless remote controllers to allow the performance of functional exercises and games that target arm movement.

TR Bedside Telerehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• TRCare, Inc.: lead
• California Rehabilitation Institute: collaborator

Study Sites (5)

California Rehabilitation Institute

Los Angeles, California, 90095, United States

Location

Casa Colina Hospital and Centers for Healthcare

Pomona, California, 91769, United States

Location

Brooks Rehabilitation

Jacksonville, Florida, 32216, United States

Location

Jefferson Moss-Magee Rehabilitation

Philadelphia, Pennsylvania, 19102, United States

Location

University of Utah - Craig H. Neilsen Rehabilitation Hospital

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Stroke; Brain Injuries, Traumatic; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Spinal Cord Diseases

Study Officials

• Michael Su, MD

  California Rehabilitation Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 6, 2023
• Study Start: May 9, 2024
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)