Home-based Balance Training Using Wii Fit After Stroke: A Feasibility Study (WiiMobil)
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|ClinicalTrials.gov Identifier: NCT02251470|
Recruitment Status : Completed
First Posted : September 29, 2014
Last Update Posted : December 2, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Other: HBE Wii (EG) Other: HBE Control (CG)||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||The Application of a Video-game System (Nintendo Wii®) as an Independent Exercise Program to Improve Mobility After Stroke - a Randomized Phase II Trial|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||August 2015|
Experimental: 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).
Other: HBE Wii (EG)
Wii-Fit Balance games (Soccer Heading, Ski Slalom, Table Tilt, Balance Bubble etc.)
Active Comparator: 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).
Other: HBE Control (CG)
Simple balance exercises with own body weight (Single limb stance, stepping, side sways etc.)
- Feasibility [ Time Frame: 12-weeks ]Recruiting potential, the participants' acceptance/satisfaction of the intervention and economic aspects
- Mobility [ Time Frame: Baseline - after 6 weeks - after 12 weeks ]Berg Balance Scale, Dynamic Gait Index, Timed Up and Go (TUG) Test, Activities-Specific Balance Confidence Scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02251470
|Hospital "BG-Kliniken Bergmannstrost"|
|Halle, Saxony-Anhalt, Germany, D-06112|
|University Hospital Halle|
|Halle, Saxony-Anhalt, Germany, D-06120|
|Study Director:||Wilfried Mau, Prof. Dr.||Institute of Rehabilitation Medicine|
|Study Chair:||André Golla||Institute of Rehabilitation Medicine|