The Application of a Video-game System (Nintendo Wii®) as an Independent Exercise Program to Improve Mobility After Stroke - a Randomized Phase II Trial
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- Martin-Luther-Universität Halle-Wittenberg
- Enrollment
- 14
- Locations
- 2
- Primary Endpoint
- Feasibility
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Investigators
André Golla
André Golla
Martin-Luther-Universität Halle-Wittenberg
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Feasibility
Time Frame: 12-weeks
Recruiting potential, the participants' acceptance/satisfaction of the intervention and economic aspects
Secondary Outcomes
- Mobility(Baseline - after 6 weeks - after 12 weeks)