- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03759106
Optimizing a Home-based Virtual Reality Exercise Program for Chronic Stroke Patients: A Telerehabilitation Approach
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Alejandro Hernandez, MSc
- Phone Number: 514-340-2085
- Email: alejandro.hernandez@mail.mcgill.ca
Study Contact Backup
- Name: Dahlia Kairy, phd
- Phone Number: 514-343-6301
- Email: dahlia.kairy@umontreal.ca
Study Locations
-
-
Quebec
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Montréal, Quebec, Canada, H3N 1X7
- Recruiting
- Université de Montréal
-
Contact:
- Dorra Allegue, MSc
- Email: dorra.allegue@umontreal.ca
-
Contact:
- Alejandro Hernandez, MSc
- Email: alejandro.hernandez@mail.mcgill.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: No Intervention: Usual care
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.
|
exercises such as picking up objects, placing objects, frequently prescribed at discharge
|
Experimental: Experimental: Telerehabilitation system
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.
|
Video games using the Kinect camera that are carried out using the impaired arm and monitored by a therapist by videoconferencing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in Upper limb motor control at 8 weeks as measured using the Fugl-Meyer Assessment-UE (FMA-UE)
Time Frame: baseline and eight weeks after intervention, as well as 1 and 2 month follow up
|
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
|
baseline and eight weeks after intervention, as well as 1 and 2 month follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: baseline and eight weeks after intervention, as well as 1 and 2 month follow up
|
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.
|
baseline and eight weeks after intervention, as well as 1 and 2 month follow up
|
Change from Baseline in Upper limb function at 8 weeks using the Wolf Motor Function Test
Time Frame: baseline and eight weeks after intervention, as well as 1 and 2 month follow up
|
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.
|
baseline and eight weeks after intervention, as well as 1 and 2 month follow up
|
number of sessions (feasibility)
Time Frame: 8 weeks (ongoing)
|
number of sessions played (count)
|
8 weeks (ongoing)
|
duration of sessions (Feasibility)
Time Frame: 8 weeks (ongoing)
|
average duration of sessions played (minutes)
|
8 weeks (ongoing)
|
Amount of time spent on the actual exe games (moving the arm)
Time Frame: 8 weeks (ongoing)
|
amount of actual time spent using the impaired arm during the sessions (minutes)
|
8 weeks (ongoing)
|
Frequency of on-line consultations with therapist
Time Frame: 8 weeks (ongoing)
|
Number of times real-time sessions are held between the therapist and the participant (online)
|
8 weeks (ongoing)
|
duration (minutes) of on-line consultations with therapist
Time Frame: 8 weeks (ongoing)
|
average time spent by the therapist assisting for real-time sessions
|
8 weeks (ongoing)
|
adverse event (counts)
Time Frame: 8 weeks (ongoing)
|
occurrence of adverse events (falls, motion sickness, dizziness, headaches) will be documented using a computerized patient log after each session.
|
8 weeks (ongoing)
|
falls (count)
Time Frame: 8 weeks (ongoing)
|
occurrence of falls documented by the participant
|
8 weeks (ongoing)
|
adverse event - exertion (Borg Exertion Scale scored from 6-20, no exertion to maximal exertion)
Time Frame: 8 weeks (ongoing)
|
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)
|
8 weeks (ongoing)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Dahlia Kairy, PhD, Université de Montréal
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRIR-1319-0218
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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