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Telerehabilitation Early After CNS Injury

Primary Purpose

Cerebral Stroke, Traumatic Brain Injury, Spinal Cord Injuries

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HandyMotion Treatment Program
Sponsored by
TRCare, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Stroke focused on measuring Stroke, Traumatic Brain Injuries, Spinal Cord Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • California Rehabilitation Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TR Bedside Telerehabilitation

Arm Description

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.

Outcomes

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
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
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
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.

Full Information

First Posted
September 27, 2023
Last Updated
October 9, 2023
Sponsor
TRCare, Inc.
Collaborators
California Rehabilitation Institute
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1. Study Identification

Unique Protocol Identification Number
NCT06069999
Brief Title
Telerehabilitation Early After CNS Injury
Official Title
Bedside Telerehabilitation Early After CNS Injury
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TRCare, Inc.
Collaborators
California Rehabilitation Institute

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Stroke, Traumatic Brain Injury, Spinal Cord Injuries
Keywords
Stroke, Traumatic Brain Injuries, Spinal Cord Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TR Bedside Telerehabilitation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
HandyMotion Treatment Program
Intervention Description
A pair of sensor-based wireless remote controllers to allow the performance of functional exercises and games that target arm movement.
Primary Outcome Measure Information:
Title
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
Description
Safety will be measured in terms of adverse events (AEs) deemed related to use of the telerehabilitation system on a probable or definite basis.
Time Frame
"For approximately 4 weeks, up until discharge"
Secondary Outcome Measure Information:
Title
Feasibility of daily bedside telerehabilitation based on measurement of patient compliance, as determined by reviewing electronic records of device usage
Description
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.
Time Frame
"baseline" and "immediately after end of treatment"
Title
Box and Blocks Test
Description
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.
Time Frame
"baseline" and "immediately after end of treatment"

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Johnson K Sun
Phone
650-300-2168
Email
kit@trcare.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Su, MD
Organizational Affiliation
California Rehabilitation Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
California Rehabilitation Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Su, MD
Phone
424-522-7874
Email
cramerlab@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Michael Su, MD
First Name & Middle Initial & Last Name & Degree
Steven Cramer, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Telerehabilitation Early After CNS Injury

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