Effects of Video Game-based Physical Activity Training in People With Multiple Sclerosis in the Inpatient Period During Relapse Treatment: a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Feasibility - Recruitment process: Number of people referred from physician and eligible for screening. Number of people attending interview with researcher.
研究概览
简要总结
The study aims to investigate the feasibility and acceptability of the video game-based physical activity training program in the inpatient period during relapse treatment. The secondary aims are to investigate its effectiveness on upper extremity functions, walking, balance, cognitive functions, quality of life, depression, and fatigue comparing to conventional rehabilitation in persons with multiple sclerosis.
详细描述
Multiple sclerosis (MS) is an inflammatory, demyelinating, neurodegenerative disease of the central nervous system. The most common clinical signs and symptoms are fatigue, spasticity, cognitive impairment, chronic pain, depression, decreased quality of life, and bladder and bowel dysfunction.
Current medical treatment is divided into three groups: disease-modifying, symptom management, and prognosis and relapse management. Intravenous methylprednisolone treatment is generally used in the management of relapses and prognosis. It is also thought that physiotherapy during the intravenous methylprednisolone treatment provides better treatment results. Therefore, treatment planning of people with MS during hospitalization should be done by a multidisciplinary team.
Studies have shown that video games based physical activity training as a non-pharmacological therapy may be an effective method for managing symptoms such as balance, gait, fatigue, and cognitive functions in people with MS, but its feasibility in the inpatient period is unknown.
The primary aim of the study is to investigate the feasibility and acceptability of the video game-based physical activity training program in the inpatient period. The secondary aims are to investigate its effectiveness on upper extremity functions, walking, balance, cognitive functions, quality of life, depression, and fatigue in persons with MS comparing to conventional rehabilitation.
Volunteers from people with MS who are in the inpatient period due to relapse in the Neurology Department, Faculty of Medicine, Dokuz Eylül University will participate in the study. In accordance with the inclusion criteria, 30 patients were randomly assigned to two groups: 15 patients in the game-based rehabilitation group and 15 patients in the conventional rehabilitation group. Based on the physical levels of the patients, appropriate games will be selected and video game based physical activity training will be started. Video games will be played with Xbox One with a motion sensor (Microsoft) and a 52'' Liquid Crystal Display. Depending on the prognosis of the patients, the grades and types of games will be changed. A conventional physiotherapy program including balance, upper extremity, and core stabilization exercises will be implemented. Treatments will be given by the physiotherapist for 45 minutes once daily during the hospital stay. Evaluations will be made before and after the treatment (discharge) and 4 weeks after the end of treatment. Physical and clinical evaluations will be made by physicians and physiotherapists, and cognitive evaluation will be performed by psychologists.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Having neurological disorder other than multiple sclerosis
- •Orthopaedic surgery history covering the foot, ankle, knee, hip, or spine, affecting balance and walking
研究组 & 干预措施
Video game-based physical activity training
干预措施: Video game-based physical activity training (Behavioral)
Conventional physiotherapy program
干预措施: Conventional physiotherapy program (Behavioral)
结局指标
主要结局
Feasibility - Recruitment process: Number of people referred from physician and eligible for screening. Number of people attending interview with researcher.
时间窗: Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks
Number of people referred from physician and eligible for screening. Number of people attending interview with researcher.
Acceptability - Intervention coherence and adherence: Number of sessions attended.
时间窗: Change from Baseline through Hospital Discharge, up to 10 days
Number of sessions attended.
Acceptability - Prospective acceptability: Barriers (screening interview).
时间窗: Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks
Barriers (screening interview). Burden (reasons for not taking part/discontinuation or dropping out).
Acceptability - Experience (satisfaction, perceptions): Qualitative interview
时间窗: Change from Baseline through Hospital Discharge, up to 10 days
Qualitative interview (end of program).
次要结局
- Revised Brief Visuospatial Memory Test(Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks)
- Modified Fatigue Impact Scale(Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks)
- 2-Minute Walk Test(Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks)
- Six-Spot Step Test(Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks)
- Nine-Hole Peg Test(Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks)
- Epworth Sleepiness Scale(Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks)
- 12-Item Multiple Sclerosis Walking Scale(Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks)
- Manual Ability Measure-36(Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks)
- Hospital Anxiety and Depression Scale - Anxiety(Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks)
- Timed 25-Foot Walk(Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks)
- Hospital Anxiety and Depression Scale - Depression(Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks)
- California Verbal Learning Test-II(Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks)
- Multiple Sclerosis International Quality of Life Questionnaire(Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks)
- Symbol Digit Modalities Test(Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks)
- Paced Auditory Serial Addition Test(Change from Baseline through Hospital Discharge, up to 10 days, and 4 weeks)
研究者
Turhan Kahraman
Principal Investigator
Dokuz Eylul University