The Application of a Video-game System (Nintendo Wii®) as an Independent Exercise Program to Improve Mobility After Stroke - a Randomized Phase II Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Feasibility
研究概览
简要总结
BACKGROUND: Virtual gaming systems offer new possibilities for home-based exercises (HBE) in rehabilitation. Pilot studies with stroke patients indicate that the application of Nintendo Wii® (WII) is practicable and can improve balance under clinical conditions. However, larger trials are necessary to verify these positive effects after discharge from the hospital.
AIM: This study aims to prepare and optimize a phase III trial which compares the effects of two HBE programs for stroke patients.
METHODS: A pilot study with randomized control design and repeated measures over three-months will be conducted. Twenty elderly stroke patients will be randomly allocated to an experimental group (EG) and a control group (CG). All participants will receive an introduction to a HBE program by an individual mentoring over 6 weeks. During the following 6 weeks the participants perform the HBE on their own. The EG will perform a balance exercise program using the WII, the CG will perform a balance exercise program without technical support.
Recruiting potential, the participants' acceptance of the intervention and economic aspects will be examined. Additionally, basic information about sensitivity of change and potential effect sizes regarding the proposed instruments to measure mobility are expected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •cerebral infarction
- •place of residence: Halle (Saale) and immediate surroundings
- •television in household
- •independent ambulatory (functional ambulation classification > 3)
- •self-selected walking speed > 0,4 m/s
排除标准
- •Strong visual impairment despite visual aid
- •Deafness / verbal communication is not possible
- •distinct mobility limitations due to comorbidity
- •Body weight >120kg
- •Cardiac pacemaker
- •Acute psychiatric, disease/dementia
研究组 & 干预措施
HBE Wii (EG)
Participants receive an introduction of using the Nintendo Wii by an individual mentoring for over 6 weeks (a total of 6 sessions á 60 minutes). During the following 6 weeks the participants perform the balance exercise program (wii-fit balances games) at home (instruction: min. 3 times a week for each 30 minutes).
干预措施: HBE Wii (EG) (Other)
HBE Control (CG)
Participants receive an introduction for conventional/traditional balance exercise by an individual mentoring for over 6 weeks (a total of 6 sessions á 60 minutes). During the following 6 weeks the participants perform the balance exercise program (exercises in standing and walking) at home (instruction: min. 3 times a week for each 30 minutes).
干预措施: HBE Control (CG) (Other)
结局指标
主要结局
Feasibility
时间窗: 12-weeks
Recruiting potential, the participants' acceptance/satisfaction of the intervention and economic aspects
次要结局
- Mobility(Baseline - after 6 weeks - after 12 weeks)
研究者
André Golla
André Golla
Martin-Luther-Universität Halle-Wittenberg