使用全方位虚拟现实和跑步机训练治疗慢性中风 (PROVE)
PROVE-VR：使用全方位虚拟现实和跑步机训练对慢性中风幸存者进行的试点随机试验
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)
研究概览
地位
条件
详细说明
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
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Adria Quigley, PhD
- 电话号码：902-494-2734
- 邮箱：adriaquigley@dal.ca
学习地点
-
-
Nova Scotia
-
Halifax、Nova Scotia、加拿大、B3H 4K4
- 招聘中
- Nova Scotia Rehabilitation & Arthritis Centre
-
接触：
- Adria Quigley, PhD
- 电话号码：902-494-2734
- 邮箱：adriaquigley@dal.ca
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria
- Age ≥ 18
- Stroke ≥ 6 months ago (confirmed with chart review)
- Living within 50 km of Halifax, Nova Scotia
- Functional Ambulation Category of 3 or greater on a scale of 0-5, to ensure the participant is able to walk with supervision or independently. This criterion was selected to ensure participants could safely participate in the intervention.
- Ability to participate in low-moderate intensity aerobic or strengthening exercise for ≥ 15 minutes to ensure participants can tolerate intervention sessions of 30-45 minutes, with activity breaks, in keeping with previous stroke rehabilitation studies.
- No uncorrected visual deficits or spatial neglect
- No cardiovascular, orthopedic, or neurological diseases other than stroke impacting walking or balance
- Can follow simple instructions
- Score of < 27 on the adapted Motion Sickness Susceptibility Scale-Short based on established normative values indicating more than moderate susceptibility to motion sickness.
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Omni-VR group
20 participants will undergo 45-minute training sessions 3 times per week for 12 weeks using omnidirectional virtual reality and treadmill training. |
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. |
|
有源比较器：Control group
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. |
A traditional exercise program including strengthening and unidirectional treadmill activities for the same duration will be completed in control group. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Consent rate
大体时间：Baseline
|
Consent rate is the percentage of eligible individuals who participate. The investigators expect a consent rate of at least 40%. |
Baseline
|
|
Retention rate
大体时间：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. |
12 weeks (study completion)
|
|
Usability of the Omnidirectional Treadmill and Virtual Reality Game
大体时间：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. |
12 weeks (study completion)
|
|
Participant burden
大体时间：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. |
Baseline and 12 weeks (study completion)
|
|
Adherence
大体时间：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. |
12 weeks (study completion)
|
|
Equipment downtime
大体时间：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. |
12 weeks (study completion)
|
|
Equipment safety
大体时间：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 |
12 weeks (study completion)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Cognitive function
大体时间：Baseline and 12 weeks (study completion)
|
The investigators will use the Computerized MoCA [Montreal Cognitive Assessment] Duo to evaluate participants' cognitive function. |
Baseline and 12 weeks (study completion)
|
|
Executive Function
大体时间：Baseline and 12 weeks (study completion)
|
The investigators will use the Dimensional Change Card Sort to evaluate participants' executive function. |
Baseline and 12 weeks (study completion)
|
|
Working memory
大体时间：Baseline and 12 weeks (study completion)
|
The investigators will use the List Sorting Working Memory Test to evaluate participants' working memory. |
Baseline and 12 weeks (study completion)
|
|
Brain activation in prefrontal and premotor cortices
大体时间：Baseline and 12 weeks (study completion)
|
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) |
Baseline and 12 weeks (study completion)
|
|
Walking Speed
大体时间：Baseline and 12 weeks (study completion)
|
Walking speed using VIVE trackers on omnidirectional treadmill and overground |
Baseline and 12 weeks (study completion)
|
|
Step cadence
大体时间：Baseline and 12 weeks (study completion)
|
The investigators will evaluate step cadence using the VIVE trackers. |
Baseline and 12 weeks (study completion)
|
|
Step width
大体时间：Baseline and 12 weeks (study completion)
|
The investigators will evaluate step width using the VIVE trackers. |
Baseline and 12 weeks (study completion)
|
|
Step length
大体时间：Baseline and 12 weeks (study completion)
|
The investigators will evaluate step length using the VIVE trackers. |
Baseline and 12 weeks (study completion)
|
|
Dynamic balance
大体时间：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. |
Baseline and 12 weeks (study completion)
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Motivation of participant
大体时间：12 weeks (study completion)
|
The investigators will measure motivation by intrinsic motivation inventory. Higher scores indicate better results. |
12 weeks (study completion)
|
|
Health-related quality of life of participant
大体时间：Baseline and 12 weeks (study completion)
|
The investigators will measure health-related quality of life by the Stroke Impact Scale-3.0. Higher scores indicate better results. |
Baseline and 12 weeks (study completion)
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.