Effects of Immersive Virtual Reality on Balance, Mobility, and Fatigue in Patients With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Berg Balance Scale
研究概览
简要总结
Gait disorder, imbalance, and fatigue are the most frequently reported complaints in Multiple Sclerosis (MS), a chronic neurodegenerative disease. The first symptoms in patients with MS are emerging in the age range 20-50 and these patients need long-term rehabilitation. The virtual reality applications developed for these problems which affect the quality of life negatively and cause disability in the following periods may be a good alternative for conventional rehabilitation applications. In this long-term where motivation is important, virtual reality applications in different environments provide patients with the opportunity to do many different tasks amused. In recent years, the vividness has been increased by the 3D virtual reality headsets.
The aim of this study is to investigate the effects of immersive virtual reality on the balance, mobility, and fatigue in patients with MS.
详细描述
The study was designed as a prospective, randomized controlled study. The patients will be randomly assigned to three groups, the "immersive virtual reality (IVR)" group, the "dynamic balance training (DBT)" group and the control group. The trainings will be twice a week for 8 weeks. In the IVR group, firstly 30 minutes of Pilates training, 10 minutes of rest and then 20 minutes of virtual reality will be applied. In the DBT group, 20 minutes of dynamic balance exercises will be applied after Pilates training. In dynamic balance training, exercises will consist of similar movements required by virtual reality games. The control group will be taught relaxation exercises and will be asked to perform the exercises 2 times for 8 weeks at home.
Statistical analyses will be performed using the SPSS software version 15 (SPSS Inc. Chicago, IL, USA). The pre-training and post-training measurements of groups will be compared with the Wilcoxon Test. The significance level was set at p< 0.05.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who are ambulatory and volunteer to participate to the study, in a stable phase of the disease, without relapses in the last 1 month, with an EDSS between 0-5,5.
排除标准
- •Participants who have orthopedic, vision, hearing, or perception problems
- •Patients who have any cardiovascular or pulmonary disease in which exercise is contraindicated
研究组 & 干预措施
Virtual reality group
In virtual reality group, 30 minutes of Pilates training, 10 minutes of rest and then 20 minutes of virtual reality will be applied.
干预措施: Virtual reality group (Other)
Dynamic Balance Training
In the "Dynamic Balance Training" group, 20 minutes of dynamic balance exercises will be applied after Pilates training.
干预措施: Dynamic Balance Training (Other)
Control group
The control group will be taught relaxation exercises and will be asked to perform the exercises at home.
结局指标
主要结局
Berg Balance Scale
时间窗: Change between baseline and after 8 weeks of intervention will be assessed
Berg Balance Scale (BBS) rates performance from 0 (cannot perform) to 4 (normal performance) on 14 items. It has shown to be a valid measure with high inter and interrater reliability for people with MS.
次要结局
- Timed Up and Go Test(Change between baseline and after 8 weeks of intervention will be assessed)
- Modified Sensory Organization Test(Change between baseline and after 8 weeks of intervention will be assessed)
- One-leg standing duration(Change between baseline and after 8 weeks of intervention will be assessed)
- Fatigue Severity Scale(Change between baseline and after 8 weeks of intervention will be assessed)
- Activities-specific Balance Confidence(Change between baseline and after 8 weeks of intervention will be assessed)
- Fatigue Impact Scale(Change between baseline and after 8 weeks of intervention will be assessed)
研究者
Cagla Ozkul
Research Assistant
Gazi University