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Telerehabilitation Early After Stroke

Primary Purpose

Cerebral Stroke

Status
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

Eligibility Criteria

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

Inclusion Criteria: Age 18 years or older Stroke that is radiologically verified, due to ischemia or to intracerebral hemorrhage, and with time of stroke onset <30 days prior to enrollment; or traumatic brain injury. Unilateral arm motor deficits that are neither trivial (no arm weakness) or devastating (arm plegia). This requires that the baseline Box & Block Test score with affected arm to be at least 1 block in 60 seconds but no more than 90% of the number of blocks with the good arm. Possess enough arm movement to participate in therapy Informed consent signed by the subject 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 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 telerehabilitation therapy completed

Sites / Locations

  • Providence St. Jude Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bedside Telerehabilitation

Arm Description

Participants will be assigned 45-minute therapy training exercises each day for 5 days per week. 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.
Box and Blocks Test
Measure of Upper Extremity Function by assessing unilateral gross manual dexterity. Participant 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
November 1, 2022
Last Updated
October 4, 2023
Sponsor
TRCare, Inc.
Collaborators
Providence St. Jude Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05625438
Brief Title
Telerehabilitation Early After Stroke
Official Title
Bedside Telerehabilitation Early After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 19, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TRCare, Inc.
Collaborators
Providence St. Jude Medical Center

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. 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. 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. Five 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Stroke

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Bedside Telerehabilitation
Arm Type
Experimental
Arm Description
Participants will be assigned 45-minute therapy training exercises each day for 5 days per week. 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 2 weeks, up until 2 days prior to 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.
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. Participant 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 Stroke that is radiologically verified, due to ischemia or to intracerebral hemorrhage, and with time of stroke onset <30 days prior to enrollment; or traumatic brain injury. Unilateral arm motor deficits that are neither trivial (no arm weakness) or devastating (arm plegia). This requires that the baseline Box & Block Test score with affected arm to be at least 1 block in 60 seconds but no more than 90% of the number of blocks with the good arm. Possess enough arm movement to participate in therapy Informed consent signed by the subject 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 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 telerehabilitation 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
Natalia Covarrubias-Eckardt, MD
Organizational Affiliation
Providence St. Jude Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Providence St. Jude Medical Center
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natalia Covarrubias-Eckardt, MD
Phone
714-992-3000
Ext
1600
Email
Natalia.Covarrubias-Eckardt@stjoe.org
First Name & Middle Initial & Last Name & Degree
Natalia Covarrubias-Eckardt, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Telerehabilitation Early After Stroke

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