Clinical trial NCT02251470: Home-based Balance Training Using Wii Fit After Stroke: A Feasibility Study
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Stroke
Keywords: stroke
balance
exer-gaming
home-based exercises
Wii
postural balance
Nintendo
balance board
Wii-Fit
home
feasibility
Lead sponsor: Martin-Luther-Universität Halle-Wittenberg
Sponsor class: OTHER
First posted: 2014-09-29
Enrollment: 14
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Feasibility
timeFrame: 12-weeks
Secondary outcomes:
measure: Mobility
timeFrame: Baseline - after 6 weeks - after 12 weeks
Other outcomes:
Locations:
city: Halle
country: Germany
facility: Hospital "BG-Kliniken Bergmannstrost"
state: Saxony-Anhalt
city: Halle
country: Germany
facility: University Hospital Halle
state: Saxony-Anhalt
Study officials:
affiliation: Institute of Rehabilitation Medicine
name: Wilfried Mau, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Institute of Rehabilitation Medicine
name: André Golla
role: STUDY_CHAIR
References:
citation: 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.