Multi-user Virtual Training for Upper Extremity in the Home
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Hand displacement during each session
研究概览
简要总结
Virtual reality is a video game in which a person and their real-time movements are represented on a screen in a virtual environment. This study will compare the use of multi-user virtual reality (VR) to single-user VR to determine if either provides superior engagement in upper extremity therapy and greater motivation to perform repetitive training.
Stroke survivors will participate in a longitudinal study in which they will have the opportunity to perform rehabilitative training with multi-user VR and single-user VR modes in their homes. They will use each mode for 2 weeks, completing 4 session per week, each session is 1 hour long. Upper extremity motor control, level of engagement, and active range of motion will be assessed at time points during the intervention period.
Subject evaluations will take place before the intervention, at the midpoint of intervention (between switching from multi-user to single-user modes, or vice versa), and at the end of the intervention.
The investigators hope to address two aims:
Aim 1: To determine if the use in-home multi-user virtual reality treatment results in greater engagement in therapy compared with in-home single user virtual reality treatment.
Aim 2: To determine if in-home virtual reality treatment results in greater practice
The investigators hypothesize that stroke survivors will be more engaged in therapy when training with the multi-user VR system and this will translate into greater practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are between the ages of 21 and 80
- •Experienced a single stroke at least 6 months prior to enrollment
- •Have moderate arm impairment as indicated by a score between 4 and 6 on the Chedoke-McMaster Stroke Assessment, arm subscale
- •Live within 20 miles of the Rehabilitation Institute of Chicago (as study personnel will need to travel to their home)
排除标准
- •Other neurological, neuromuscular, or orthopedic disease
- •Pain in the upper extremity with movements required in the treatment
- •Contracture that limits use of the VR system
- •Vision problems which would preclude the ability to use the VR system
- •Cognitive or language deficits that would prevent them from understanding the tasks
- •Concurrent enrollment in another intervention study involving the affected arm or hand
- •Botox injection in the arm within the previous 6 months
研究组 & 干预措施
Multi-User Mode first, Single-User Mode second
干预措施: Single-User Virtual Reality Upper Extremity Therapy (Other)
Multi-User Mode first, Single-User Mode second
干预措施: Multi-User Virtual Reality Upper Extremity Therapy (Other)
Single-User Mode first, Multi-User Mode second
干预措施: Single-User Virtual Reality Upper Extremity Therapy (Other)
Single-User Mode first, Multi-User Mode second
干预措施: Multi-User Virtual Reality Upper Extremity Therapy (Other)
结局指标
主要结局
Hand displacement during each session
时间窗: Distance hand moves on average per session during each 2-week treatment phase (each subject will complete 2, 2-week phases of treatment. One 2-week phase being the Single-user mode and the other 2-week phase being the Multi-user mode)
total distance hand moves during all therapy sessions divided by the number of sessions in which a subject participates.
次要结局
- Therapy mode amount of use(2 week treatment phase)
- Change in Active Range of Motion(First measure taken at baseline, then also at the end of the first 2-week treatment phase and finally at the end of the second 2-week treatment phase.)
- Comparison of Intrinsic Motivation Inventory Score between therapy modes(First measure taken at the end of the first 2-week treatment phase; Second measure taken at the end of the second 2-week treatment phase.)
研究者
James Patton
Co-Director, Robotics Laboratory, Sensory Motor Performance Program, Rehabilitation Institute of Chicago
Shirley Ryan AbilityLab