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

Primary Purpose

Stroke

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
HBE Wii (EG)
HBE Control (CG)
Sponsored by
Martin-Luther-Universität Halle-Wittenberg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stroke focused on measuring stroke, balance, exer-gaming, home-based exercises, Wii, postural balance, Nintendo, balance board, Wii-Fit, home, feasibility

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital "BG-Kliniken Bergmannstrost"
  • University Hospital Halle

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HBE Wii (EG)

HBE Control (CG)

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mobility
Berg Balance Scale, Dynamic Gait Index, Timed Up and Go (TUG) Test, Activities-Specific Balance Confidence Scale

Full Information

First Posted
September 25, 2014
Last Updated
December 1, 2015
Sponsor
Martin-Luther-Universität Halle-Wittenberg
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1. Study Identification

Unique Protocol Identification Number
NCT02251470
Brief Title
Home-based Balance Training Using Wii Fit After Stroke: A Feasibility Study
Acronym
WiiMobil
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 Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Martin-Luther-Universität Halle-Wittenberg

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, balance, exer-gaming, home-based exercises, Wii, postural balance, Nintendo, balance board, Wii-Fit, home, feasibility

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HBE Wii (EG)
Arm Type
Experimental
Arm Description
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).
Arm Title
HBE Control (CG)
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
HBE Wii (EG)
Intervention Description
Wii-Fit Balance games (Soccer Heading, Ski Slalom, Table Tilt, Balance Bubble etc.)
Intervention Type
Other
Intervention Name(s)
HBE Control (CG)
Intervention Description
Simple balance exercises with own body weight (Single limb stance, stepping, side sways etc.)
Primary Outcome Measure Information:
Title
Feasibility
Description
Recruiting potential, the participants' acceptance/satisfaction of the intervention and economic aspects
Time Frame
12-weeks
Secondary Outcome Measure Information:
Title
Mobility
Description
Berg Balance Scale, Dynamic Gait Index, Timed Up and Go (TUG) Test, Activities-Specific Balance Confidence Scale
Time Frame
Baseline - after 6 weeks - after 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wilfried Mau, Prof. Dr.
Organizational Affiliation
Institute of Rehabilitation Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
André Golla
Organizational Affiliation
Institute of Rehabilitation Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital "BG-Kliniken Bergmannstrost"
City
Halle
State/Province
Saxony-Anhalt
ZIP/Postal Code
D-06112
Country
Germany
Facility Name
University Hospital Halle
City
Halle
State/Province
Saxony-Anhalt
ZIP/Postal Code
D-06120
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
30155268
Citation
Golla A, Muller T, Wohlfarth K, Jahn P, Mattukat K, Mau W. Home-based balance training using Wii Fit: a pilot randomised controlled trial with mobile older stroke survivors. Pilot Feasibility Stud. 2018 Aug 25;4:143. doi: 10.1186/s40814-018-0334-0. eCollection 2018.
Results Reference
derived

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

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