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

December 1, 2015 updated by: André Golla, Martin-Luther-Universität Halle-Wittenberg

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Saxony-Anhalt
      • Halle, Saxony-Anhalt, Germany, D-06112
        • Hospital "BG-Kliniken Bergmannstrost"
      • Halle, Saxony-Anhalt, Germany, D-06120
        • University Hospital Halle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline - after 6 weeks - after 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Martin-Luther-Universität Halle-Wittenberg

Investigators

  • Study Director: Wilfried Mau, Prof. Dr., Institute of Rehabilitation Medicine
  • Study Chair: André Golla, Institute of Rehabilitation Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

September 25, 2014

First Submitted That Met QC Criteria

September 26, 2014

First Posted (Estimate)

September 29, 2014

Study Record Updates

Last Update Posted (Estimate)

December 2, 2015

Last Update Submitted That Met QC Criteria

December 1, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRM_01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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