The primary objective of this pilot randomized controlled trial (RCT) is to test the feasibility (consent 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)
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
Omni-VR forest scenario developed by our team involving real-life dual task walking and dynamic balance activities (ie. stepping over obstacles, and managing distractions) will be used for treatment group.
A traditional exercise program including strengthening and unidirectional treadmill activities for the same duration will be completed in control group.
Nova Scotia Rehabilitation & Arthritis Centre
Halifax, Nova Scotia, Canada
RECRUITINGConsent rate
Consent rate is the percentage of eligible individuals who participate. The investigators expect a consent rate of at least 40%.
Time frame: Baseline
Retention rate
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.
Time frame: 12 weeks (study completion)
Usability of the Omnidirectional Treadmill and Virtual Reality Game
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.
Time frame: 12 weeks (study completion)
Participant burden
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.
Time frame: Baseline and 12 weeks (study completion)
Adherence
Adherence will be measured by the exercise session attendance. The investigators expect the treatment group to attend 70% or more of the sessions.
Time frame: 12 weeks (study completion)
Equipment downtime
The investigators will record any treadmill downtime due to VR technical issues. The targets are zero significant downtime in 85% of sessions.
Time frame: 12 weeks (study completion)
Equipment safety
The investigators will record any serious adverse events related to the study. The target is no serious adverse events related to the study
Time frame: 12 weeks (study completion)
Cognitive function
The investigators will use the Computerized MoCA \[Montreal Cognitive Assessment\] Duo to evaluate participants' cognitive function.
Time frame: Baseline and 12 weeks (study completion)
Executive Function
The investigators will use the Dimensional Change Card Sort to evaluate participants' executive function.
Time frame: Baseline and 12 weeks (study completion)
Working memory
The investigators will use the List Sorting Working Memory Test to evaluate participants' working memory.
Time frame: Baseline and 12 weeks (study completion)
Brain activation in prefrontal and premotor cortices
Brain activation using fNIRS \[Functional near-infrared spectroscopy\] in the prefrontal and premotor regions of interest during a single task (steady-state omnidirectional treadmill walking) and two cognitive-physical dual-task activities (simple dual-task: steady-state omnidirectional treadmill walking while repeating the same word and complex dual-task: steady-state omnidirectional treadmill walking while performing a verbal fluency test)
Time frame: Baseline and 12 weeks (study completion)
Walking Speed
Walking speed using VIVE trackers on omnidirectional treadmill and overground
Time frame: Baseline and 12 weeks (study completion)
Step cadence
The investigators will evaluate step cadence using the VIVE trackers.
Time frame: Baseline and 12 weeks (study completion)
Step width
The investigators will evaluate step width using the VIVE trackers.
Time frame: Baseline and 12 weeks (study completion)
Step length
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The investigators will evaluate step length using the VIVE trackers.
Time frame: Baseline and 12 weeks (study completion)
Dynamic balance
The investigators will measure the static sway with feet together using omni-VR system and use MINI-BESTest to measure the dynamic balance.
Time frame: Baseline and 12 weeks (study completion)