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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
Sponsor:
Information provided by (Responsible Party):
André Golla, Martin-Luther-Universität Halle-Wittenberg

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.


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
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


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.)




Primary Outcome Measures :
  1. Feasibility [ Time Frame: 12-weeks ]
    Recruiting potential, the participants' acceptance/satisfaction of the intervention and economic aspects


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
Germany
Hospital "BG-Kliniken Bergmannstrost"
Halle, Saxony-Anhalt, Germany, D-06112
University Hospital Halle
Halle, Saxony-Anhalt, Germany, D-06120
Sponsors and Collaborators
Martin-Luther-Universität Halle-Wittenberg
Investigators
Study Director: Wilfried Mau, Prof. Dr. Institute of Rehabilitation Medicine
Study Chair: André Golla Institute of Rehabilitation Medicine

Responsible Party: André Golla, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier: NCT02251470     History of Changes
Other Study ID Numbers: IRM_01
First Posted: September 29, 2014    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: December 2015

Keywords provided by André Golla, Martin-Luther-Universität Halle-Wittenberg:
stroke
balance
exer-gaming
home-based exercises
Wii
postural balance
Nintendo
balance board
Wii-Fit
home
feasibility

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases