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临床试验/NCT02251470
NCT02251470已完成1 期

The Application of a Video-game System (Nintendo Wii®) as an Independent Exercise Program to Improve Mobility After Stroke - a Randomized Phase II Trial

Martin-Luther-Universität Halle-Wittenberg4 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2014年10月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
14
试验地点
4
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

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

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

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

André Golla

André Golla

Martin-Luther-Universität Halle-Wittenberg

研究点 (4)

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