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临床试验/NCT03045380
NCT03045380已完成不适用

Effect of Video Game Based Physical Activity Training on Upper Extremity Functions, Walking, Balance and Cognitive Functions in Persons With Multiple Sclerosis

Dokuz Eylul University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Nine-Hole Peg Test

研究概览

简要总结

The study was designed to investigate the effect of video games based physical activity training on upper extremity functions, walking, balance and cognitive functions in persons with multiple sclerosis (MS). For this aim, the participants with MS will be divided into three groups: game based physical activity training, conventional rehabilitation, and no intervention groups. The experimental groups will receive therapy sessions once a week for 8 weeks. The no intervention group will receive no intervention, they will be assessed at baseline and after 8 weeks.

详细描述

MS is an inflammatory, demyelinating, and neurodegenerative disease of the central nervous system. The most common clinical signs and symptoms are fatigue, spasticity, affecting mobility, cognitive impairment, chronic pain, depression, decreased quality of life, and bladder and bowel dysfunction.

In order to increase and maintain the quality of life of individuals with MS these disease-related progressive symptoms need to be managed. For this reason, patients 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, tremor, fatigue, cognitive functions in persons with MS.

The primary purpose of the study was to examine the effects and persistence of 8-week video games-based physical activity training in MS patients on upper extremity functions, walking, balance, cognitive functions, quality of life, depression and fatigue. The second aim of the study was to investigate the effect and persistence of traditional physiotherapy of 8 weeks on MS patients on upper extremity functions, walking, balance, cognitive functions, quality of life, depression and fatigue. The third aim of the study is to compare the effects of 8-week videogame-based physical activity training and traditional physiotherapy in MS patients.

Volunteers from persons with MS who are in routine control of the MS Outpatient Clinic of Neurology Department, Faculty of Medicine, Dokuz Eylül University will participate in the study. In accordance with the inclusion criteria, 51 patients were randomly assigned to three groups: 17 patients in the game based rehabilitation group, 17 patients in the conventional rehabilitation group and 17 patients in the no intervention 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 motion sensor (Microsoft) and a 52'' Liquid Crystal Display. Depending on the prognosis of the patients, the grades of the games and types of the games will be changed. The program will be administered once a week for 8 weeks. A conventional physiotherapy program including balance, upper extremity, and core stabilization exercises will be implemented. Sessions will take 5-10 minutes warm up, 15-20 minutes exercise and 5-10 minute cool down periods. The program will be administered once a week for 8 weeks. No intervention group formed from waitlist will receive no intervention.

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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Relapsing-remitting or secondary progressive multiple sclerosis
  • Able to walk at least 100 meters without resting
  • Able to stand for at least half an hour
  • Willingness to participate in the study

排除标准

  • Neurological disease other than multiple sclerosis
  • A relapse during the study
  • Having undergone orthopedic surgery involving the foot-ankle, knee, hip, spine, affecting balance
  • Serious cognitive or psychiatric disorder

研究组 & 干预措施

Game based rehabilitation

Experimental

Game based rehabilitation will be administered once a week for 8 weeks.

干预措施: Game based physical activity training (Other)

Conventional rehabilitation

Active Comparator

Conventional physiotherapy program will be administered once a week for 8 weeks.

干预措施: Conventional physiotherapy (Other)

No intervention

No Intervention

Waitlist

结局指标

主要结局

Nine-Hole Peg Test

时间窗: Change from Baseline at 8 weeks

The Nine-Hole Peg Test measures finger dexterity.

次要结局

  • 12-Item Multiple Sclerosis Walking Scale(Change from Baseline at 8 weeks)
  • Activities-specific Balance Confidence Scale(Change from Baseline at 8 weeks)
  • Multiple Sclerosis International Quality of Life Questionnaire(Change from Baseline at 8 weeks)
  • Expanded Disability Status Scale(Baseline)
  • Sit-Up Test(Change from Baseline at 8 weeks)
  • Manual Ability Measure-36(Change from Baseline at 8 weeks)
  • Brief International Cognitive Assessment for Multiple Sclerosis(Change from Baseline at 8 weeks)
  • Timed 25-Foot Walk(Change from Baseline at 8 weeks)
  • Six-Spot Step Test(Change from Baseline at 8 weeks)
  • Five Times Sit to Stand Test(Change from Baseline at 8 weeks)
  • Modified Fatigue Impact Scale(Change from Baseline at 8 weeks)
  • Beck Depression Inventory(Change from Baseline at 8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Turhan Kahraman

Principal Investigator

Dokuz Eylul University

研究点 (1)

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