The Effects of Lokomat Virtual Reality Applications on Balance and Gait in Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Change in 6 MWT
研究概览
简要总结
The effectiveness of applying robot-assisted walking training together with conventional physiotherapy is widely accepted. Virtual reality is another component and its contribution to rehabilitation is important. When we look at the literature on virtual reality applications on balance and walking, it is seen that some systems are beneficial while some systems have no effect. This raises the possibility that virtual reality applications may produce different results due to the task in the exercise, patient motivation or any other reason. There is a need to investigate whether virtual reality applications have different effects, if any, what is the source of this and what care should be taken in the development of these applications in the future. Therefore, we focused on investigating the different effects of Lokomat virtual reality applications.
详细描述
Stroke is an important health problem worldwide. Emotional, cognitive, sensory and motor problems occur with stroke. Motor problems are especially balance and walking problems and they are related to each other. So balance and gait rehabilitation are primary goals in stroke.
Although the first study to support the efficacy of Lokomat is that Lokomat is superior to conventional physiotherapy in walking, there are also studies reporting that there is no difference between the effects of Lokomat and conventional physiotherapy and that conventional physiotherapy is superior. In the light of all these studies, the effectiveness of applying robotic systems together with conventional physiotherapy is widely accepted.
Robot Assisted Walking Training has many components such as guiding force, walking speed, body weight support. Virtual reality is one of these components and there is literature in which Lokomat virtual reality applications are effective on balance and walking. Although the virtual reality effect is emphasized for Lokomat, there is a lack of literature on the specific effect of different virtual reality applications. In our study, it was aimed to examine the changes caused by different Lokomat virtual reality applications in the spatiotemporal parameters of balance and gait.
Method: This study was conducted to examine the effects of Lokomat VR applications on balance and spatiotemporal parameters of gait in patients with chronic stroke; It is a prospective, randomized controlled, single-blind study. The study will be carried out in a single-blind manner, and the evaluator will not know which group the individual is in. 56 individuals with chronic stroke included our study. All individuals have been informed about the study and read and signed the consent form stating that they voluntarily participated in the study. For balance evaluation we used Berg Balance Scale and Huber 360 device, which measures postural stability and limits of stability. And for gait evaluation we used 10 MWT, 6 MWT and spatiotemporal gait analysis for C-Mill VR+.
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)
盲法说明
The assessor has been masked.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Clinical diagnosis is stroke
- •The time period have to be chronic period (+6 months)
- •The patient must have the ability to walk with or without support
- •The patiens should be able to understand Lokomat exercises
排除标准
- •Any condition that may prevent walking with Lokomat
- •Not volunteering to participate in the study
结局指标
主要结局
Change in 6 MWT
时间窗: 6 weeks after treatment
6 Minutes Walk Test is a test using for walking distance. We evaluated the change in walking distance with 6 MWT.
Change in BBS
时间窗: 6 weeks after treatment
Berg Balance Scale used for balance assesment. The scale consists of 14 items and each item gets a score between 0-4. As a result, the person evaluated gets a score between 0-56 on the berg balance scale. A higher score means the person has better balance skills.
Change in Spatiotemporal Gait Analysis
时间窗: 6 weeks after treatment
Spatiotemporal gait analysis gives spatial (distance) parameters along with temporal (time) parameters. * Spatial parameters: * Step Length * Step Width * Stride Length * Temporal Parameters * Step Time * Stride Time * Stance Time * Swing Time * Double Support Time We used C-Mill device to evaluate the spatiotemporal parameters.
Change in Limits of Stability
时间窗: 6 weeks after treatment
Limits of Stability (LoS) are defined as the points at which the center of gravity (CoG) approaches the limits of the base of support (BoS) and a correction strategy is required to return the center of mass (CoM) to within the BoS. In other words, LoS is the amount of maximum excursion an individual is able to intentionally cover in any direction without losing his/her balance or taking a step. We used Huber 360 device to evaluate the LoS.
Change in 10 MWT
时间窗: 6 weeks after treatment
10 MWT is a test using for evaluate the gait speed. Gait speed is a spatiotemporal parameter.
次要结局
- Change in Temporal Symmetry(6 weeks after treatment)
- Change in Spatial Symmetry(6 weeks after treatment)
- Change in Postural Stability(6 weeks after treatment)
研究者
Murat Akıncı
Principal Investigator
Ankara Yildirim Beyazıt University