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Optimizing a Home-based Virtual Reality Exercise Program for Chronic Stroke Patients: A Telerehabilitation Approach

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
home written exercise program
telerehabilitation/exergame system
Sponsored by
Université de Montréal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Virtual reality, telerehabilitation, Stroke rehabilitation

Eligibility Criteria

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

Inclusion Criteria:

  • Ischemic or hemorrhagic stroke (does not have to be a first time stroke);
  • Mild to moderate upper limb impairment (score 2-6 Chedoke-McMaster arm component or ability to perform VR tasks at least at the lowest setting according to clinician);
  • No longer receiving rehabilitation services;
  • living in an area where high speed Internet access is available.

Exclusion Criteria:

  • Being medically unstable;
  • Severe cognitive or communication deficits;
  • Visual impairments;
  • Severe balance deficits limiting sitting safely independently;
  • Shoulder pain limiting movements for the game;
  • Previous upper limb impairment limiting potential recovery.

Sites / Locations

  • Université de MontréalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

No Intervention: Usual care

Experimental: Telerehabilitation system

Arm Description

All study participants in the control group will receive an 8-week written home exercise program (e.g. GRASP) , i.e. the usual care discharge home program.

Participants in the experimental group will receive 8 weeks home exercise program using a virtual reality (VR) and telerehabilitation system. The intensity and choice of game for the home program will be determined by the therapist based on the patient's abilities, interests, motivation and fatigue. The patient's performance for the VR home program will be monitored asynchronously and synchronously and the program adapted to ensure it remains at an appropriate level for the patient.

Outcomes

Primary Outcome Measures

Change from Baseline in Upper limb motor control at 8 weeks as measured using the Fugl-Meyer Assessment-UE (FMA-UE)
Upper limb motor control is assessed using a valid and reliable outcome, scores between 0-66, higher scores indicating better motor control. measure consisting of tasks to be performed by the participant

Secondary Outcome Measures

Change from Baseline in Upper limb function at 8 weeks Impact on upper extremity use in daily activities will be using the Motor Activity Log, a self-reported measure of upper limb use
The Motor Activity Log is a questionnaire that the participant completes reporting how much the impaired upper limb is used for various daily tasks, each task is scored from 0-5 (ordinal scale, 0=do not use arm - 6=use as much as before), total score is mean of the scores.
Change from Baseline in Upper limb function at 8 weeks using the Wolf Motor Function Test
The Wolf Motor Function test consists of tasks that are performed by the participant with the impaired upper extremity, the tasks are rated for the quality of movement and the time taken. Items are scored on a 6 point scale, from does not attempt to movement is normal. Times tests are truncated at 120 seconds. A mean score out of a maximum of 5 is calculated.
number of sessions (feasibility)
number of sessions played (count)
duration of sessions (Feasibility)
average duration of sessions played (minutes)
Amount of time spent on the actual exe games (moving the arm)
amount of actual time spent using the impaired arm during the sessions (minutes)
Frequency of on-line consultations with therapist
Number of times real-time sessions are held between the therapist and the participant (online)
duration (minutes) of on-line consultations with therapist
average time spent by the therapist assisting for real-time sessions
adverse event (counts)
occurrence of adverse events (falls, motion sickness, dizziness, headaches) will be documented using a computerized patient log after each session.
falls (count)
occurrence of falls documented by the participant
adverse event - exertion (Borg Exertion Scale scored from 6-20, no exertion to maximal exertion)
self perceived exertion rated by the participant after the session (i.e. playing the exergame) on a scale 6-20, (no exertion to maximal exertion)

Full Information

First Posted
November 27, 2018
Last Updated
November 10, 2022
Sponsor
Université de Montréal
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT03759106
Brief Title
Optimizing a Home-based Virtual Reality Exercise Program for Chronic Stroke Patients: A Telerehabilitation Approach
Official Title
Optimizing a Home-based Virtual Reality Exercise Program for Chronic Stroke Patients: A Telerehabilitation Approach
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 27, 2019 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Montréal
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Stroke is a leading cause of death and long-term disability worldwide and its incidence is on the rise. Importantly, loss of arm function occurs in up to 85% of stroke survivors, with a significant long-term impact on activities of daily living, leisure activities and work. The capacity for recovery following a stroke depends on several factors, including the extent of the initial neurological damage, spontaneous recovery and rehabilitation, with possible recovery even years after the stroke. Unfortunately, accessibility of much needed rehabilitation services poststroke often remains limited, both in terms of intensity and duration, as reported in a recent report on post-stroke rehabilitation services in Quebec. Recent evidence suggests that homebased telerehabilitation (TR) is a viable approach for upper limb training post-stroke when rehabilitation services are not available. Similarly, the Canadian Best Practice Recommendations for Stroke Care update for 2013 recommends home-based patient monitoring be used when frequent monitoring is needed and face-to-face visits are not available. Hence, the investigators have developed and propose to examine the use of the VirTele system for people who have suffered a stroke who are no longer receiving rehabilitation services The VirTele system allows upper limb rehabilitation using exergames with ongoing off-line monitoring combined with online monitoring and coaching based on the self-determination theory.
Detailed Description
More specifically, the primary objective of the RCT is to provide preliminary evidence regarding efficacy of the VirTele program for upper limb motor control recovery in chronic stroke. Secondary objectives are to: i. Determine the effect of the VirTele program on upper limb function, quality of life and motivation; ii. Determine the feasibility of using the VirTele program with users at home (e.g. adherence, safety, technical difficulties, facilitators and barriers); iii. Explore the role that shared decision-making and empowerment play in exercise program adherence and progression, and in behavior modification for upper-limb use. This study will also provide evidence of feasibility for conducting a larger-scale RCT comparing different technologies and interventions for chronic stroke rehabilitation. A single-blind (evaluator) two-arm randomized clinical trial (RCT) is proposed for this study with participants who have had a stroke randomly allocated to: (1) 8-week training with the VirTele system.i.e. treatment group or (2) 8-week written home exercise program provided by a clinician (GRASP), i.e. exercise control group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Virtual reality, telerehabilitation, Stroke rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No Intervention: Usual care
Arm Type
Other
Arm Description
All study participants in the control group will receive an 8-week written home exercise program (e.g. GRASP) , i.e. the usual care discharge home program.
Arm Title
Experimental: Telerehabilitation system
Arm Type
Experimental
Arm Description
Participants in the experimental group will receive 8 weeks home exercise program using a virtual reality (VR) and telerehabilitation system. The intensity and choice of game for the home program will be determined by the therapist based on the patient's abilities, interests, motivation and fatigue. The patient's performance for the VR home program will be monitored asynchronously and synchronously and the program adapted to ensure it remains at an appropriate level for the patient.
Intervention Type
Other
Intervention Name(s)
home written exercise program
Intervention Description
exercises such as picking up objects, placing objects, frequently prescribed at discharge
Intervention Type
Other
Intervention Name(s)
telerehabilitation/exergame system
Intervention Description
Video games using the Kinect camera that are carried out using the impaired arm and monitored by a therapist by videoconferencing
Primary Outcome Measure Information:
Title
Change from Baseline in Upper limb motor control at 8 weeks as measured using the Fugl-Meyer Assessment-UE (FMA-UE)
Description
Upper limb motor control is assessed using a valid and reliable outcome, scores between 0-66, higher scores indicating better motor control. measure consisting of tasks to be performed by the participant
Time Frame
baseline and eight weeks after intervention, as well as 1 and 2 month follow up
Secondary Outcome Measure Information:
Title
Change from Baseline in Upper limb function at 8 weeks Impact on upper extremity use in daily activities will be using the Motor Activity Log, a self-reported measure of upper limb use
Description
The Motor Activity Log is a questionnaire that the participant completes reporting how much the impaired upper limb is used for various daily tasks, each task is scored from 0-5 (ordinal scale, 0=do not use arm - 6=use as much as before), total score is mean of the scores.
Time Frame
baseline and eight weeks after intervention, as well as 1 and 2 month follow up
Title
Change from Baseline in Upper limb function at 8 weeks using the Wolf Motor Function Test
Description
The Wolf Motor Function test consists of tasks that are performed by the participant with the impaired upper extremity, the tasks are rated for the quality of movement and the time taken. Items are scored on a 6 point scale, from does not attempt to movement is normal. Times tests are truncated at 120 seconds. A mean score out of a maximum of 5 is calculated.
Time Frame
baseline and eight weeks after intervention, as well as 1 and 2 month follow up
Title
number of sessions (feasibility)
Description
number of sessions played (count)
Time Frame
8 weeks (ongoing)
Title
duration of sessions (Feasibility)
Description
average duration of sessions played (minutes)
Time Frame
8 weeks (ongoing)
Title
Amount of time spent on the actual exe games (moving the arm)
Description
amount of actual time spent using the impaired arm during the sessions (minutes)
Time Frame
8 weeks (ongoing)
Title
Frequency of on-line consultations with therapist
Description
Number of times real-time sessions are held between the therapist and the participant (online)
Time Frame
8 weeks (ongoing)
Title
duration (minutes) of on-line consultations with therapist
Description
average time spent by the therapist assisting for real-time sessions
Time Frame
8 weeks (ongoing)
Title
adverse event (counts)
Description
occurrence of adverse events (falls, motion sickness, dizziness, headaches) will be documented using a computerized patient log after each session.
Time Frame
8 weeks (ongoing)
Title
falls (count)
Description
occurrence of falls documented by the participant
Time Frame
8 weeks (ongoing)
Title
adverse event - exertion (Borg Exertion Scale scored from 6-20, no exertion to maximal exertion)
Description
self perceived exertion rated by the participant after the session (i.e. playing the exergame) on a scale 6-20, (no exertion to maximal exertion)
Time Frame
8 weeks (ongoing)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ischemic or hemorrhagic stroke (does not have to be a first time stroke); Mild to moderate upper limb impairment (score 2-6 Chedoke-McMaster arm component or ability to perform VR tasks at least at the lowest setting according to clinician); No longer receiving rehabilitation services; living in an area where high speed Internet access is available. Exclusion Criteria: Being medically unstable; Severe cognitive or communication deficits; Visual impairments; Severe balance deficits limiting sitting safely independently; Shoulder pain limiting movements for the game; Previous upper limb impairment limiting potential recovery.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alejandro Hernandez, MSc
Phone
514-340-2085
Email
alejandro.hernandez@mail.mcgill.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Dahlia Kairy, phd
Phone
514-343-6301
Email
dahlia.kairy@umontreal.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dahlia Kairy, PhD
Organizational Affiliation
Université de Montréal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Université de Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3N 1X7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dorra Allegue, MSc
Email
dorra.allegue@umontreal.ca
First Name & Middle Initial & Last Name & Degree
Alejandro Hernandez, MSc
Email
alejandro.hernandez@mail.mcgill.ca

12. IPD Sharing Statement

Citations:
PubMed Identifier
32097119
Citation
Allegue DR, Kairy D, Higgins J, Archambault P, Michaud F, Miller W, Sweet SN, Tousignant M. Optimization of Upper Extremity Rehabilitation by Combining Telerehabilitation With an Exergame in People With Chronic Stroke: Protocol for a Mixed Methods Study. JMIR Res Protoc. 2020 May 21;9(5):e14629. doi: 10.2196/14629.
Results Reference
derived

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Optimizing a Home-based Virtual Reality Exercise Program for Chronic Stroke Patients: A Telerehabilitation Approach

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