NCT06069999

Telerehabilitation Early After CNS Injury

Bedside Telerehabilitation Early After CNS Injury

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: TRCare, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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. Aim 3: To derive a preliminary estimate of motor and functional outcomes in patients engaged in daily bedside telerehabilitation. This is an uncontrolled pilot study, and so it is understood that such measures cannot be attributed to the telerehabilitation intervention, however, these measures will describe the clinical course of a patient engaged in this intervention. Telerehabilitation therapy is delivered over the course of the inpatient rehabilitation stay. A therapist-facing web portal is used for treatment planning and patient monitoring. The treatment approach was initially designed based on an upper-extremity task-specific training manual and Accelerated Skill Acquisition Program. Each daily 45-minute treatment session is created by a licensed OT or PT and includes: A. At least 15 min/day of upper extremity exercises. In addition, therapists have the option to incorporate standard exercise equipment (e.g., Theraband or dowels) that can be incorporated into assigned exercises. B. At least 15 min/day of functional training through games. The study provides 2 controllers with 5 different input devices that are available to drive game play. Games stress various motor control features (e.g., varying movement speed, range of motion, target size, extent of visuomotor tracking, or level of cognitive demand), which are selected and adjusted by the therapist. C. If applicable, 5 minutes/day of stroke education. The education content targets five categories (Stroke Risk Factors, Stroke Prevention, Effects of Stroke, Diet, and Exercise) and corresponds to the Stroke Knowledge Exam. The remaining 10-15 minutes consist of additional exercises and games, per the judgment of the licensed OT or PT.

Conditions

• Cerebral Stroke
• Traumatic Brain Injury
• Spinal Cord Injuries

Interventions

Type	Name	Description
DEVICE	HandyMotion Treatment Program	A pair of sensor-based wireless remote controllers to allow the performance of functional exercises and games that target arm movement.

Timeline

• Start date: 2024-05-09
• Primary completion: 2025-10-30
• Completion: 2025-10-30
• First posted: 2023-10-06
• Last updated: 2025-08-29

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study