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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hospital "BG-Kliniken Bergmannstrost", Halle, Saxony-Anhalt, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HBE Wii (EG)

Other

Wii-Fit Balance games (Soccer Heading, Ski Slalom, Table Tilt, Balance Bubble etc.)

HBE Control (CG)

Other

Simple balance exercises with own body weight (Single limb stance, stepping, side sways etc.)

Primary outcomes

Feasibility

Time frame: 12-weeks

Recruiting potential, the participants' acceptance/satisfaction of the intervention and economic aspects

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Martin-Luther-Universität Halle-Wittenberg

Other

Registry information

Official study 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

Acronym: WiiMobil

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Sep 29, 2014
Registry last updated: Dec 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed