Virtual Reality and Field Training to Enhance Community Walking After Stroke
ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-74
SponsorMcGill University
About this trial
While stroke survivors discharged from rehabilitation present with some recovery in mobility, their ability to ambulate in the community remains limited. The investigators propose to test a novel, low-cost, intensive and individually tailored intervention that combines virtual reality (VR) and field training to enhance community ambulation and participation in stroke survivors discharged from rehabilitation.
The aims are to: (1) Assess feasibility, acceptability, safety and adherence of the intervention in stroke survivors; and (2) Examine the extent to which post-intervention changes in functional walking and participation to community walking vary according to walking, cognitive and visual-perceptual abilities.
The investigators will use a virtual environment prototype simulating a shopping mall and surrounding streets, in which participants will interact using VR goggles and game controllers. Scenarios of increasing levels of complexity will be introduced. This intervention study involves a single group, multiple pre- multiple post- study design where chronic stroke participants will engage in a 4-week training program. The program will include VR training sessions performed in the clinical setting (3/week) and practice of community ambulation skills while supervised by family/caregivers (2/week). Participants will be assessed on measures of functional walking, balance \& mobility and participation to community walking. Adherence, safety and acceptability will be documented. This study will generate foundation knowledge on the response to the intervention based on individual capacities.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
First-ever supratentorial unilateral stroke 9-24 months ago (such chronicity will ensure steady-state mobility without long-term disuse-related changes
Mild-to-moderate hemiparesis (Chedoke McMaster Stoke Assessment stages 4/7-6/7 on postural control, leg & foot)
Ability to walk independently with/without walking aids for at least 1 min at 0.4-0.9 m/s (such a speed range indicates mobility not sufficient for functional community ambulation: shopping ~1.1m/s, street crossing ~1.2 m/s)
Intact or mildly affected cognitive function (Montreal Cognitive Assessment scores ≥ 22/30)
Disqualifiers
Subjects with comorbidities interfering with walking
Subjects with comorbidities interfering with visual perception
Subjects without medical clearance for exercise
Trial design
Design model
Single group
Treatments tested in this trial
Virtual Reality and Field Training (VRFT)
Other interventionThe VRFT intervention involves the intensive practice of community ambulation skills. Some of the training sessions will be performed in a virtual environment, while others will consist of field training exercises in the community. During the intervention, stroke participants will be invited to practice different dimensions of community ambulation, such as postural transitions, avoiding other pedestrians, dual-task walking, etc.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Virtual Reality and Field Practice Training (VRFT)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Post-intervention change in the Six Minute Walk Test (6MWT)
The six-minute walk test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.
Time frame
Pre-intervention (Week4) and post-intervention (Week8)2
Change in the Six Minute Walk Test (6MWT) at Follow-up
The six-minute walk test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.
Time frame
Post-intervention (Week8) and Follow-up (Week12)Secondary outcomes
1
Dynamic Gait Index
Developed to assess the likelihood of falling in older adults
Time frame
Baseline (Week0), pre-intervention (Week4), post-intervention (Week8) and follow-up (Week12)2
5m Walk Test
Assesses walking speed in meters per seconds over a short duration
Time frame
Baseline (Week0), pre-intervention (Week4), post-intervention (Week8) and follow-up (Week12)3
Activities-Specific Balance Confidence Scale
16-item self-reported measure of balance confidence performing various activities without losing balance or experiencing a sense of unsteadiness. Items are rated on a 0%-100% response scale, with a score of 0 representing no confidence and a score of 100 representing complete confidence.
Time frame
Baseline (Week0), pre-intervention (Week4), post-intervention (Week8) and follow-up (Week12)4
Trip Activity Log
Questionnaire to record the number of trips and walking-related activities in the community (e.g. outside home) 3 days preceding its administration
Time frame
Baseline (Week0), pre-intervention (Week4), post-intervention (Week8) and follow-up (Week12)Other outcomes
1
Adherence to intervention
Training logbook filled by researchers/clinicians (virtual reality) and subjects (field training) component)
Time frame
3x/week over the 4-week intervention for the virtual reality component; 2x/week over the 4-week intervention for the field training component2
Safety of the intervention
Assesses by systematically collecting any occurrence of adverse/unwanted events (falls, injuries, fatigue, etc).
Time frame
3x/week over the 4-week intervention of the virtual reality component3
Acceptability of the intervention
Assesses using the Technology Acceptance Model based Questionnaire (Tam-Q) based on the technology acceptance model, in which subjects will rate their perception on each dimension using a visual analog scale ranging from 0-56, with higher score representing higher acceptance to the intervention.
Time frame
Post-intervention (Week8)4
Cadence
Cadence is the rate at which a person walks (steps per minute) and will be measured with the GaitRite system.
Time frame
Pre-intervention (Week4) and post-intervention (Week8)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
McGill University
Lead sponsor
Jewish Rehabilitation Hospital
Collaborator
Integrated University Health and Social Services Center of the Capitale-Nationale
Collaborator
Laval University
Collaborator
Source ClinicalTrials.gov