Home-based Balance Training Using Wii Fit After Stroke: A Feasibility Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Stroke

Intervention / Treatment
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* Other: HBE Wii (EG)
* Other: HBE Control (CG)


Participation Criteria
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Eligibility Criteria
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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 Epilepsy Cardiac pacemaker Acute psychiatric, disease/dementia

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HBE Wii (EG)<br>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). | Other: HBE Wii (EG)<br>* Wii-Fit Balance games (Soccer Heading, Ski Slalom, Table Tilt, Balance Bubble etc.)<br>|
| Active Comparator: HBE Control (CG)<br>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). | Other: HBE Control (CG)<br>* Simple balance exercises with own body weight (Single limb stance, stepping, side sways etc.)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility | Recruiting potential, the participants' acceptance/satisfaction of the intervention and economic aspects | 12-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mobility | Berg Balance Scale, Dynamic Gait Index, Timed Up and Go (TUG) Test, Activities-Specific Balance Confidence Scale | Baseline - after 6 weeks - after 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, balance, exer-gaming, home-based exercises, Wii, postural balance, Nintendo, balance board, Wii-Fit, home, feasibility