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

Phase 1

Completed

• Conditions: Stroke
• Interventions: Other: HBE Wii (EG); Other: HBE Control (CG)

• Registration Number: NCT02251470
• Lead Sponsor: Martin-Luther-Universität Halle-Wittenberg

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-25
• Study First Submitted QC: 2014-09-26
• Study First Posted: 2014-09-29
• Study Start: 2014-10
• Primary Completion: 2015-06
• Study Completion: 2015-08
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-01
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HBE Wii (EG)	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).
HBE Control (CG)	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).

Primary Outcome Measures

Name	Time	Method
Feasibility	12-weeks	Recruiting potential, the participants' acceptance/satisfaction of the intervention and economic aspects

Secondary Outcome Measures

Name	Time	Method
Mobility	Baseline - after 6 weeks - after 12 weeks	Berg Balance Scale, Dynamic Gait Index, Timed Up and Go (TUG) Test, Activities-Specific Balance Confidence Scale

Trial Locations

Locations (2)

University Hospital Halle; 🇩🇪 Halle, Saxony-Anhalt, Germany

Hospital "BG-Kliniken Bergmannstrost"; 🇩🇪 Halle, Saxony-Anhalt, Germany