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

Stroke Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02251470
• Other study ID #: IRM_01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 25, 2014
• Last updated: December 1, 2015
• Start date: October 2014
• Est. completion date: August 2015

Study information

• Verified date: December 2015
• Source: Martin-Luther-Universität Halle-Wittenberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• HBE Wii (EG)
Wii-Fit Balance games (Soccer Heading, Ski Slalom, Table Tilt, Balance Bubble etc.)
• HBE Control (CG)
Simple balance exercises with own body weight (Single limb stance, stepping, side sways etc.)

Locations

Country	Name	City	State
Germany	Hospital "BG-Kliniken Bergmannstrost"	Halle	Saxony-Anhalt
Germany	University Hospital Halle	Halle	Saxony-Anhalt

Sponsors (1)

Lead Sponsor	Collaborator
Martin-Luther-Universität Halle-Wittenberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility	Recruiting potential, the participants' acceptance/satisfaction of the intervention and economic aspects	12-weeks	No
Secondary	Mobility	Berg Balance Scale, Dynamic Gait Index, Timed Up and Go (TUG) Test, Activities-Specific Balance Confidence Scale	Baseline - after 6 weeks - after 12 weeks	No