Using Omnidirectional Virtual Reality and Treadmill Training for Chronic Stroke
- Conditions
- Stroke
- Interventions
- Device: Omnidirectional Virtual Reality and Treadmill TrainingBehavioral: Traditional Exercise
- Registration Number
- NCT06495450
- Lead Sponsor
- Nova Scotia Health Authority
- Brief Summary
The primary objective of this pilot randomized controlled trial (RCT) is to test the feasibility (recruitment rate, retention rate, participant burden, adherence, technical issues, safety) and usability (system usability scale, SUS) of Omnidirectional treadmill Virtual Reality training (omni-VR) among chronic stroke survivors. Our secondary objective is to (1) estimate the extent to which cognition, brain activation during a dual task activity, walking ability, and dynamic balance change after 3 months of training among intervention participants (omni-VR) and traditional exercise controls, and (2) estimate the extent to which health-related quality of life and motivation co-evolve with our secondary outcomes.
Researchers will compare the intervention group and control group to evaluate the impact of omni-VR on cognition and physical function among stroke survivors.
Participants will:
* undergo a 45-minute training session 3 times per week for 12 weeks
* intervention group: omni-VR
* control group: traditional exercise program (strengthening and walking activities)
- Detailed Description
Mounting data indicates that cognition plays a role in complex walking and balance. However, conventional intervention methods lack a sufficient incentive to encourage participants to adhere to the treatment. Further, it is difficult to provide a substantial amount of treatment to induce cortical reorganization.
Virtual reality or VR (a computer-generated simulation of 3-dimensional virtual environments that reacts in real time to the user's actions) has been introduced to neurorehabilitation to promote improvements in walking ability, balance, and cognition. It has also been demonstrated to be effective in improving motivation among stroke survivors and augmenting neuroplasticity.
Omnidirectional treadmill technology can be integrated with VR to allow for fully immersive rehabilitation. This novel and innovative technology mimics real-world environments and maximizes challenging cognitive and physical dual-tasking and balance activities while maintaining patient safety. However, no randomized trials have evaluated the impact of omnidirectional treadmill VR (Omni-VR) on cognitive and physical function among stroke survivors.
Therefore, our study aims to test the feasibility and usability of the Omni-VR. This pilot randomized control trial will also be the first study to test the feasibility and effect of a fully-immersive active omni-VR system among chronic stroke survivors
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- Stroke ≥ 6 months ago (per conventional stroke trials)
- Living within 50 km of Halifax, Nova Scotia
- Functional Ambulation Category ≥ 3
- Self-reported walking limitations (Walk-12 score > 20)
- Ability to exercise for ≥ 15 minutes
- No visual deficits or hemispatial neglect
- No other cardiovascular, orthopedic, or neurological diseases impacting walking or balance
- Montreal Cognitive Assessment (MoCA) scores > 18 indicating moderate or severe cognitive impairment
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Omni-VR group Omnidirectional Virtual Reality and Treadmill Training 20 participants will undergo 45-minute training sessions 3 times per week for 12 weeks using omnidirectional virtual reality and treadmill training. Control group Traditional Exercise 10 participants will undergo 45-minute traditional physiotherapy training sessions including lower limb strengthening and unidirectional treadmill training 3 times per week for 12 weeks.
- Primary Outcome Measures
Name Time Method Participant burden Baseline and 12 weeks (study completion) Participant burden will be measured by the percentage of participants finishing assessments in 100 minutes or less. The investigators anticipate at least 85% of participants completing assessments within the time limit.
Equipment downtime 12 weeks (study completion) The investigators will record any treadmill downtime due to VR technical issues. The targets are zero significant downtime in 85% of participants.
Equipment safety 12 weeks (study completion) The investigators will record any adverse events. The target is no serious adverse events.
Recruitment rate Baseline Recruitment rate is the percentage of eligible individuals who participate. The investigators expect a recruitment rate of at least 40%.
Retention rate 12 weeks (study completion) Retention rate is the percentage of participants who complete the 12-week intervention. The investigators expect a retention rate of 80% for the intervention group.
Adherence 12 weeks (study completion) Adherence will be measured by the exercise session attendance. The investigators expect the treatment group to attend 70% or more of the sessions.
Usability of the Omnidirectional Treadmill and Virtual Reality Game 12 weeks (study completion) Usability will be assessed by System Usability Scale (SUS) out of 100 points. The investigators expect a SUS score of 71 or higher among all participants.
- Secondary Outcome Measures
Name Time Method Cognitive function Baseline and 12 weeks (study completion) The investigators will use the Computerized MoCA \[Montreal Cognitive Assessment\] Duo, the computerized Tower of London to evaluate participants' cognitive function.
Brain activation in prefrontal and premotor cortices Baseline and 12 weeks (study completion) The investigators will examine brain activity in the prefrontal and premotor cortices using fNIRS \[Functional near-infrared spectroscopy\] during both single and dual-task scenarios.
Walking Speed Baseline and 12 weeks (study completion) The investigators will evaluate walking speed through the omni-VR system.
Dynamic balance Baseline and 12 weeks (study completion) The investigators will measure the static sway with feet together using omni-VR system and use MINI-BESTest to measure the dynamic balance.
Step cadence Baseline and 12 weeks (study completion) The investigators will evaluate step cadence through the omni-VR system.
Step width Baseline and 12 weeks (study completion) The investigators will evaluate step width through the omni-VR system.
Step length Baseline and 12 weeks (study completion) The investigators will evaluate step length through the omni-VR system.
Trial Locations
- Locations (1)
Nova Scotia Rehabilitation & Arthritis Centre
🇨🇦Halifax, Nova Scotia, Canada