Effects of Video Game-based Physical Activity Training in Persons With Multiple Sclerosis With Restless Legs Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- International Restless Legs Syndrome Study Group rating scale for restless legs syndrome
研究概览
简要总结
In this studly, the effects of an 8-week videogame-based physical activity training in persons with multiple sclerosis will be investigated.
详细描述
Multiple sclerosis is a chronic, progressive, and demyelinating disease of the central nervous system that affects more than 2.5 million people worldwide and is more common in young adults. The most common clinical signs and symptoms include fatigue, spasticity, cognitive impairment, chronic pain, depression, decreased quality of life, and bladder and bowel dysfunction.
Sleep disturbance is affecting more than 50% of persons with multiple sclerosis. Restless legs syndrome is one of the factors causing sleep disturbance in persons with multiple sclerosis. Studies have showed that the incidence of restless legs syndrome in persons with multiple sclerosis is about five times more than the general population.
In order to increase and maintain the quality of life of persons with multiple sclerosis, the disease-related progressive symptoms need to be managed. Therefore, persons with multiple sclerosis need long-term rehabilitation. This situation reduces the motivation of the people over time and makes the continuity of treatment difficult. Developments in rehabilitation technology aim to contribute to the treatment process as well as to increase the active participation of individuals with chronic diseases.
Current literature has shown that video-based physical activity training as non-pharmacological therapy may be an effective method for symptoms such as balance, walking, fatigue, cognitive functions in persons with multiple sclerosis, but the effects on restless legs syndrome are not known.
The main aim of the study is to investigate the effects of 8-week video game-based physical activity training in persons with multiple sclerosis with restless legs syndrome.
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
- •A relapsing-remitting or secondary progressive type of multiple sclerosis,
- •Being able to walk at least 100 meters without resting,
- •Being able to stably stand for half an hour,
- •To be willing to participate in the study.
排除标准
- •Another neurological disorder,
- •Relapse during the study period,
- •Orthopedic surgery history including the ankle-foot, knee, hip, or spine, affecting balance,
- •Diagnosed severe cognitive and/or psychiatric impairment
结局指标
主要结局
International Restless Legs Syndrome Study Group rating scale for restless legs syndrome
时间窗: Change from Baseline at 8 and 16 weeks
The International Restless Legs Syndrome Study Group rating scale for restless legs syndrome is used to assess severity of the restless legs syndrome symptoms. It consists of 10 items scored by 0 to 4. Possible scores range from 0 to 40. Higher scores indicate higher severity.
次要结局
- Timed Up and Go test(Change from Baseline at 8 and 16 weeks)
- 6-Minute Walk Test(Change from Baseline at 8 and 16 weeks)
- 12-Item Multiple sclerosis walking scale(Change from Baseline at 8 and 16 weeks)
- Timed 25-Foot Walk(Change from Baseline at 8 and 16 weeks)
- Epworth Sleepiness Scale(Change from Baseline at 8 and 16 weeks)
- Hospital Anxiety And Depression Scale - Anxiety(Change from Baseline at 8 and 16 weeks)
- Multiple Sclerosis International Quality of Life questionnaire(Change from Baseline at 8 and 16 weeks)
- Multiple Sclerosis-Related Symptom Checklist(Change from Baseline at 8 and 16 weeks)
- Godin Leisure Time Exercise Questionnaire(Change from Baseline at 8 and 16 weeks)
- Modified Fatigue Impact Scale(Change from Baseline at 8 and 16 weeks)
- Hospital Anxiety And Depression Scale - Depression(Change from Baseline at 8 and 16 weeks)
研究者
Turhan Kahraman
Principal Investigator
Izmir Katip Celebi University