Telerehabilitation Early After CNS Injury

Traumatic Brain Injury Clinical Trial

Official title:

Bedside Telerehabilitation Early After CNS Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06069999
• Other study ID #: TRC-09
• Status: Recruiting
• Phase: N/A
• Start date: May 9, 2024
• Est. completion date: May 2025

Study information

• Verified date: May 2024
• Source: TRCare, Inc.
• Contact: Johnson K Sun
• Phone: 650-300-2168
• Email: kit[@]trcare.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Cerebral Stroke
• Spinal Cord Injuries
• Stroke
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	Brooks Rehabilitation	Jacksonville	Florida
United States	California Rehabilitation Institute	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
TRCare, Inc.	California Rehabilitation Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Feasibility of daily bedside telerehabilitation based on measurement of patient compliance, as determined by reviewing electronic records of device usage	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.	"baseline" and "immediately after end of treatment"
Secondary	Box and Blocks Test	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.	"baseline" and "immediately after end of treatment"