Feasibility and Safety of an Immersive Virtual Reality-based Vestibular Rehabilitation Program for Dizziness, Balance and Fatigue Improvement in People With Multiple Sclerosis: Protocol for a Pilot Randomised Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Safety of virtual reality-based vestibular rehabilitation
研究概览
简要总结
The effectiveness of convectional vestibular training for balance and dizziness rehabilitation in people with multiple sclerosis has been recently demonstrated in a meta-analysis by this research team (doi: 10.3390/jcm9020590). Furthermore, non-immersive virtual reality-based environments seem to be useful for balance and gait rehabilitation in this population (doi: 10.1177/0269215518768084). However, nothing is known about the feasibility and effectiveness of immersive virtual reality-based rehabilitation in people with multiple sclerosis.
The primary aim of this research is to determine the feasibility, safety and effectiveness of an immersive virtual reality-based vestibular training for dizziness, balance and fatigue rehabilitation, compared to conventional vestibular training.
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)
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
- •Both male and female subjects from 18-65 years old
- •Clinically diagnosed with any type of multiple sclerosis in accordance with the revised McDonald criteria
- •With walking ability according to the Expanded Disability Status Scale score (EDSS =6)
- •With the objective presence of dizziness symptoms (Dizziness Handicap Inventory = 16)
排除标准
- •Blurred vision
- •Cognitive impairment (Mini Mental State Examination =24)
- •Another neurologic disorder contributing to balance impairment
- •Relapse within the last 3 months
- •Changes in pharmacotherapy within the last 3 months
- •History of vestibular rehabilitation within the last 6 months
- •Acute cardiovascular of respiratory illness
- •Any other contraindication to physical activity
研究组 & 干预措施
Immersive virtual reality-based vestibular training.
Subjects in this group will receive the same intervention than the other group of study, but they will wear a 3D head mounted display (Oculus Quest glasses) and will receive real-time gaming feedback in terms of visual and audio output while using the training system.
Participants will receive a total of 20 sessions (3 sessions of 50 minutes per week, 7 weeks). These sessions will be divided in 10 initial sessions (based on the three first blocks of Cawthorne-Cooksey protocol) and 10 advanced sessions in which vestibular exercises are gradually get more complicated by modifiying the following exercise parameters: base of support width, standing on unstable surface, alternatives single leg support, tandem position, increased velocity of head movements, higher head range motion and coordinated movements with arms and trunk.
Same location, tailoring parameters and physical therapist supervision than conventional vestibular training.
干预措施: Immersive Virtual-based vestibular rehabilitation (Other)
Conventional vestibular training.
Subjects in the control group will receive a total of 20 sessions of 50 minutes (3 sessions per week, 7 weeks). They will receive traditional "Cawthorne-Cooksey" vestibular rehabilitation exercises. This program improves vestibular compensation through a mechanism of neuroplasticity known as adaptation, habituation and substitution. Just like the virtual reality intervention it will be divided in 10 initial sessions and 10 advanced sessions. For the advanced phase of intervention exercises parameters were the same described for the virtual vestibular rehabilitation intervention.
A physical therapy with at least two years of expertise in vestibular rehabilitation will adjust the difficulty level. The intervention will be conducted at the Physical Therapy Department of the University of Sevilla (Spain).
干预措施: Conventional vestibular rehabilitation protocol (Other)
结局指标
主要结局
Safety of virtual reality-based vestibular rehabilitation
时间窗: 7 weeks of intervention
Cybersickness: Scores ranging between 10 and 15 mean significant symptoms and above 20 indicates a simulator problem Falls registry Adverse events registry
Feasibility of virtual reality-based vestibular rehabilitation
时间窗: 7 weeks of intervention
Usability of virtual reality device: System Usability Scale (0-100%). Higher Scores means higher usability Participation rate Retention rate Adherence to treatment rate
次要结局
- Change from baseline dizziness symptoms at 7 weeks(7 weeks after intervention)
- Change from baseline fatigue at 7 weeks(7 weeks after intervention)
- Change from baseline static balance at 7 weeks(7 weeks after intervention)
- Change from baseline quality of life at 7 weeks(7 weeks after intervention)
研究者
Maria Jesus Casuso-Holgado
Assistant Professor
University of Seville