Telerehabilitation Early After CNS Injury

Bedside Telerehabilitation Early After CNS Injury

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Traumatic Brain Injury; Spinal Cord Injuries; Cerebral Stroke
• Intervention / Treatment: Device: HandyMotion Treatment Program

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Johnson K Sun; Phone Number: 650-300-2168; Email: kit@trcare.net

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • California Rehabilitation Institute
      • Contact: Michael Su, MD; Phone Number: 424-522-7874; Email: cramerlab@mednet.ucla.edu
      • Principal Investigator: Michael Su, MD
      • Sub-Investigator: Steven Cramer, MD
  • Florida
    • Jacksonville, Florida, United States, 32216
      • Brooks Rehabilitation
      • Contact: Mark Bowden, PhD; Phone Number: 904-345-6626; Email: mark.bowden@brooksrehab.org
      • Contact: Bob McIver, DPT; Phone Number: 904.345.6812; Email: bob.mciver@brooksrehab.org
      • Principal Investigator: Ken Ngo, MD
      • Sub-Investigator: Mark Bowden, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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"
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"

Collaborators and Investigators

• Sponsor: TRCare, Inc.
• Collaborators: California Rehabilitation Institute
• Investigators: Principal Investigator: Michael Su, MD, California Rehabilitation Institute

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: September 27, 2023
• First Submitted That Met QC Criteria: October 3, 2023
• First Posted (Actual): October 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Stroke; Telehealth; Telerehabilitation; Spinal Cord Injuries; Traumatic Brain Injuries; Brain Plasticity
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Spinal Cord Diseases; Stroke; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Spinal Cord Injuries
• Other Study ID Numbers: TRC-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No