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

Martin-Luther-Universität Halle-Wittenberg

Status and phase: Completed; Phase 2; Phase 1

Conditions: Stroke

Treatments: Other: HBE Control (CG); Other: HBE Wii (EG)

Study type: Interventional

Funder types: Other

Identifiers

NCT02251470

IRM_01

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 60+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

HBE Wii (EG)

Experimental group

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).

Treatment:

Other: HBE Wii (EG)

HBE Control (CG)

Active Comparator group

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).

Treatment:

Other: HBE Control (CG)