Optimizing a Home-based Virtual Reality Exercise Program for Chronic Stroke Patients: A Telerehabilitation Approach
1 other identifier
interventional
52
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Jun 2019
Longer than P75 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2018
CompletedFirst Posted
Study publicly available on registry
November 29, 2018
CompletedStudy Start
First participant enrolled
June 27, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedNovember 14, 2022
November 1, 2022
3.8 years
November 27, 2018
November 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
baseline and eight weeks after intervention, as well as 1 and 2 month follow up
Secondary Outcomes (10)
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
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
baseline and eight weeks after intervention, as well as 1 and 2 month follow up
number of sessions (feasibility)
8 weeks (ongoing)
duration of sessions (Feasibility)
8 weeks (ongoing)
Amount of time spent on the actual exe games (moving the arm)
8 weeks (ongoing)
- +5 more secondary outcomes
Study Arms (2)
No Intervention: Usual care
OTHERAll 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.
Experimental: Telerehabilitation system
EXPERIMENTALParticipants 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.
Interventions
exercises such as picking up objects, placing objects, frequently prescribed at discharge
Video games using the Kinect camera that are carried out using the impaired arm and monitored by a therapist by videoconferencing
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Université de Montréal
Montreal, Quebec, H3N 1X7, Canada
Related Publications (1)
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.
PMID: 32097119DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dahlia Kairy, PhD
Université de Montréal
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 27, 2018
First Posted
November 29, 2018
Study Start
June 27, 2019
Primary Completion
May 1, 2023
Study Completion
December 1, 2023
Last Updated
November 14, 2022
Record last verified: 2022-11