PROVE-VR: A Pilot Randomized Trial Using Omnidirectional Virtual Reality and Treadmill Training for Chronic Stroke Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Retention rate
研究概览
简要总结
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)
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Unstable serious medical condition
- •Resting blood pressure >180/100mmHg
- •History of abnormal untreated heart rhythm
- •Pregnancy
- •Condition limiting ability to complete or tolerate the exercises without major program modifications (e.g., chronic low back pain)
- •Serious comorbid condition that would affect participation in the intervention (e.g., active cancer, severe heart disease)
- •Severe loss of hearing or speech that would preclude VR use
- •Participant weight more than 264 lbs (weight limit for Virtualizer Elite 2 treadmill)
- •Participating in another formal lower limb exercise program > 1 day per week
- •History of QT prolongation or using potential QT prolonging drugs
结局指标
主要结局
Retention rate
时间窗: 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.
Usability of the Omnidirectional Treadmill and Virtual Reality Game
时间窗: 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.
Participant burden
时间窗: 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.
Adherence
时间窗: 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.
Equipment downtime
时间窗: 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 sessions.
Equipment safety
时间窗: 12 weeks (study completion)
The investigators will record any serious adverse events related to the study. The target is no serious adverse events related to the study
Consent rate
时间窗: Baseline
Consent rate is the percentage of eligible individuals who participate. The investigators expect a consent rate of at least 40%.
Retention rate
时间窗: 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.
Usability of the Omnidirectional Treadmill and Virtual Reality Game
时间窗: 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.
Participant burden
时间窗: 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.
Adherence
时间窗: 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.
Equipment downtime
时间窗: 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 sessions.
Equipment safety
时间窗: 12 weeks (study completion)
The investigators will record any serious adverse events related to the study. The target is no serious adverse events related to the study
次要结局
- Brain activation in prefrontal and premotor cortices(Baseline and 12 weeks (study completion))
- Walking Speed(Baseline and 12 weeks (study completion))
- Step cadence(Baseline and 12 weeks (study completion))
- Step width(Baseline and 12 weeks (study completion))
- Step length(Baseline and 12 weeks (study completion))
- Dynamic balance(Baseline and 12 weeks (study completion))
- Cognitive function(Baseline and 12 weeks (study completion))
- Step cadence(Baseline and 12 weeks (study completion))
- Step width(Baseline and 12 weeks (study completion))
- Step length(Baseline and 12 weeks (study completion))
- Walking Speed(Baseline and 12 weeks (study completion))
- Brain activation in prefrontal and premotor cortices(Baseline and 12 weeks (study completion))
- Dynamic balance(Baseline and 12 weeks (study completion))
- Cognitive function(Baseline and 12 weeks (study completion))
- Executive Function(Baseline and 12 weeks (study completion))
- Working memory(Baseline and 12 weeks (study completion))
研究者
Adria Quigley
Assistant Professor
Dalhousie University