Home-based Balance Training Using Wii Fit After Stroke: A Feasibility Study
WiiMobil
The Application of a Video-game System (Nintendo Wii®) as an Independent Exercise Program to Improve Mobility After Stroke - a Randomized Phase II Trial
1 other identifier
interventional
14
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 stroke
Started Oct 2014
Shorter than P25 for phase_1 stroke
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2014
CompletedFirst Posted
Study publicly available on registry
September 29, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedDecember 2, 2015
December 1, 2015
8 months
September 25, 2014
December 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Feasibility
Recruiting potential, the participants' acceptance/satisfaction of the intervention and economic aspects
12-weeks
Secondary Outcomes (1)
Mobility
Baseline - after 6 weeks - after 12 weeks
Study Arms (2)
HBE Wii (EG)
EXPERIMENTALParticipants 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)
ACTIVE COMPARATORParticipants 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).
Interventions
Wii-Fit Balance games (Soccer Heading, Ski Slalom, Table Tilt, Balance Bubble etc.)
Simple balance exercises with own body weight (Single limb stance, stepping, side sways etc.)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hospital "BG-Kliniken Bergmannstrost"
Halle, Saxony-Anhalt, D-06112, Germany
University Hospital Halle
Halle, Saxony-Anhalt, D-06120, Germany
Related Publications (1)
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.
PMID: 30155268DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Wilfried Mau, Prof. Dr.
Institute of Rehabilitation Medicine
- STUDY CHAIR
André Golla
Institute of Rehabilitation Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- André Golla
Study Record Dates
First Submitted
September 25, 2014
First Posted
September 29, 2014
Study Start
October 1, 2014
Primary Completion
June 1, 2015
Study Completion
August 1, 2015
Last Updated
December 2, 2015
Record last verified: 2015-12