A Virtual Reality and Field Training Toolkit to Enhance Community Ambulation and Participation in Stroke Survivors
概览
- 阶段
- 不适用
- 干预措施
- Virtual Reality and Field Training (VRFT)
- 疾病 / 适应症
- Stroke
- 发起方
- McGill University
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Post-intervention change in the Six Minute Walk Test (6MWT)
- 状态
- 招募中
- 最后更新
- 2个月前
概览
简要总结
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.
详细描述
Ambulating in community environments requires the skills to cope with multiple, simultaneous dimensions such as walking speed and distance, etc. Such skills remain compromised in the majority of stroke survivors due to insufficient or lack of targeted practice. The investigators propose to test a new, individually-tailored intervention, developed by the research team, grounded in best evidence in community ambulation, principles of motor learning and participatory action research. This unique intervention will combine virtual reality (VR) and field training practice to optimize learning that can be generalized to daily walking activities. Participants will engage in the 4-week, individually-tailored intervention that comprises of supervised VR training sessions (3 times/week) performed in the clinical setting. VR sessions will be completed by field training assignments. Subjects will be assessed twice prior to the intervention, immediately after the intervention and at follow up. Generalized estimating equations will be used to compare changes in main and secondary outcomes across time points, with each personal factor of interest (e.g. walking capacity, visual-perceptual function, and cognitive function) analyzed individually while adjusting for age. Outcomes on adherence, safety and acceptability will be analyzed with descriptive statistics. Required sample size was estimated based on Green's rule (effect size=0.5, power=80%, α=0.05) with a variance inflation factor assuming moderate within-subject correlations for 3 post-baseline measurement time points. This yields a sample size of 30. Assuming a worst-case scenario of 30% attrition rate, a total of 40 stroke subjects (20/site) will be recruited.
研究者
Anouk Lamontagne
Associate Professor
McGill University
入排标准
入选标准
- •People with chronic stroke and persistent deficits in walking / visual-perceptual / cognitive capacities. They can be male or female, aged from 40 to 74 years, with normal/corrected visual and auditory acuity, and present with:
- •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)
- •Intact to moderately affected visual-perceptual function (positive scores on a maximum of 3/6 tasks on the Behavioural Inattention Test)
排除标准
- •Subjects with comorbidities interfering with walking
- •Subjects with comorbidities interfering with visual perception
- •Subjects without medical clearance for exercise
研究组 & 干预措施
Virtual Reality and Field Practice Training (VRFT)
Participants will engage in a 4-week VRFT intervention that comprises of 1-hour training sessions, 3 times/week.
干预措施: Virtual Reality and Field Training (VRFT)
结局指标
主要结局
Post-intervention change in the Six Minute Walk Test (6MWT)
时间窗: Pre-intervention (Week4) and post-intervention (Week8)
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.
Change in the Six Minute Walk Test (6MWT) at Follow-up
时间窗: Post-intervention (Week8) and Follow-up (Week12)
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.
次要结局
- Assessment of Life Habits (Life-H: mobility and community life domains)(Baseline (Week0), pre-intervention (Week4), post-intervention (Week8) and follow-up (Week12))
- Activities-Specific Balance Confidence Scale(Baseline (Week0), pre-intervention (Week4), post-intervention (Week8) and follow-up (Week12))
- Dynamic Gait Index(Baseline (Week0), pre-intervention (Week4), post-intervention (Week8) and follow-up (Week12))
- 5m Walk Test(Baseline (Week0), pre-intervention (Week4), post-intervention (Week8) and follow-up (Week12))
- Environmental Analysis of Mobility Questionnaire(Baseline (Week0), pre-intervention (Week4), post-intervention (Week8) and follow-up (Week12))
- Trip Activity Log(Baseline (Week0), pre-intervention (Week4), post-intervention (Week8) and follow-up (Week12))