Telerehabilitation Early After CNS Injury

Sponsor

TRCare, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06069999

Collaborator

California Rehabilitation Institute (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Stroke Traumatic Brain Injury Spinal Cord Injuries	Device: HandyMotion Treatment Program	N/A

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:

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.
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.
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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Bedside Telerehabilitation Early After CNS Injury

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Nov 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TR Bedside Telerehabilitation 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 A pair of sensor-based wireless remote controllers to allow the performance of functional exercises and games that target arm movement.

Arm

Intervention/Treatment

Experimental: TR Bedside Telerehabilitation

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

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

Outcome Measures

Primary Outcome Measures

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 ["For approximately 4 weeks, up until discharge"]
Safety will be measured in terms of adverse events (AEs) deemed related to use of the telerehabilitation system on a probable or definite basis.

Secondary Outcome Measures

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"]
Feasibility will be measured in terms of patient compliance, specifically the fraction of days where a patient is assigned to do bedside telerehabilitation and initiates a treatment session. Any factors related to reduced compliance, including technical and medical factors, will be recorded. Feasibility is a composite measure. It is descriptive, so that all of these observations can be combined into a single outcome.
Box and Blocks Test ["baseline" and "immediately after end of treatment"]
Measure of Upper Extremity Function by assessing unilateral gross manual dexterity. Participants will be asked to perform the test twice for each side to assess bilateral gross manual dexterity. Participants will be asked to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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