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

Completed

Phase 1/2 Results N/A

Trial Description

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.

Conditions

Interventions

  • HBE Wii Other
    Intervention Desc: Wii-Fit Balance games (Soccer Heading, Ski Slalom, Table Tilt, Balance Bubble etc.)
    ARM 1: Kind: Experimental
    Label: HBE Wii
    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).
  • HBE Control Other
    Intervention Desc: Simple balance exercises with own body weight (Single limb stance, stepping, side sways etc.)
    ARM 1: Kind: Experimental
    Label: HBE Control
    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).
  • HBE Wii (EG) Other
    Intervention Desc: Wii-Fit Balance games (Soccer Heading, Ski Slalom, Table Tilt, Balance Bubble etc.)
    ARM 1: Kind: Experimental
    Label: HBE Wii (EG)
    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).
  • HBE Control (CG) Other
    Intervention Desc: Simple balance exercises with own body weight (Single limb stance, stepping, side sways etc.)
    ARM 1: Kind: Experimental
    Label: HBE Control (CG)
    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).

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Supportive Care
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Feasibility 12-weeks No
Secondary Mobility Baseline - after 6 weeks - after 12 weeks No

Sponsors