Wii FIT Balance Board to Recording Balance Parameters in Multiple Sclerosis Subjects

Completed

• Conditions: Postural Balance; Multiple Sclerosis
• Interventions: Device: Nintendo Wii Fit Balance Board

• Registration Number: NCT02287948
• Lead Sponsor: University Hospital of Ferrara

Brief Summary

Balance disorders are frequently observed in patients with Multiple Sclerosis (MS) and the deterioration of the static and dynamic control of balance is an important and basic symptom of disease progression.

Measure balance disorders with force platforme requires personnel and represent a significant cost.

The platform Nintendo Wii Fit represents a valid economic alternative

Detailed Description

Balance disorders are frequently observed in patients with MS and are the most disabling symptoms; in subjects with moderate disabilities for balance, the deterioration of the static and dynamic control of balance is an important and basic symptom of disease progression.

From a clinical point of view, the reliability of being able to discriminate patients who have the highest probability of falling than those with lower probability is crucial to develop a program aimed at the prevention of falls.

Potentially the parameters measured wiht torque platform can be an objective, reliable and accurate for discriminating patients with the highest probability of falling than those with low probability, and may be useful to highlight the deficits and improvements in the ability to maintain balance after specific rehabilitation. However posturographic systems represent a significant cost, require a dedicated and qualified personnel to use. A possible solution to not use force platforms could be the implementation of software to interface with the Nintendo Wii Fit Balance Board (WBB) with a personal computer.

The platform Nintendo Wii Fit presents a set of sensors lower compared to a traditional force platform, but can represent a valid economic alternative to more complex systems, in addition to being already used as a rehabilitation tool in the literature in more than one study. Studies in healthy subjects have valid information on the study of the center of pressure (COP) obtained from WBB showing that the path lengths of the COP obtained from the WBB were valid and well correlated with those recorded by a dynamometric platform.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-11-06
• Study First Submitted QC: 2014-11-06
• Study First Posted: 2014-11-11
• Primary Completion: 2015-12
• Study Completion: 2016-01
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-02
• Last Update Posted: 2016-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MS subjects group	Nintendo Wii Fit Balance Board	Multiple sclerosis subjects wiht mild-moderate gait disability with EDSS score not higher than 5.5
Healthy subjects group	Nintendo Wii Fit Balance Board	Healthy subjects age-matched with multiple sclerosis subjects.

Primary Outcome Measures

Name	Time	Method
Parameters related with postural balance and the chance to fall	one evaluation in one day	Instrumental evaluations carry out on the same day.; All subjects will perform the following tasks both on force platform and Wii Fit Balance Board: * Open eyes, monopodalic balance for 20 seconds; * Closed eyes, monopodalic balance for 20 seconds; * Open eyes, balance on both feet for 60 seconds; * Closed eyes, balance on both feet for 60 seconds; During trials subjects can leave arms in the most comfortable position they prefere Subjects will perform every task for 5 times; they can rest for 30 seconds between every trials.

Secondary Outcome Measures

Name	Time	Method
Timed "up and go" test (TUG)	one evaluation in one day	Timed "up and go" test validity has been demonstrated with Berg Balance test correlation, gait speed and ability to step on the stairs; this test has been recently validated for multiple sclerosis subjects evaluation.
Dynamic Gait Index (DGI)	one evaluation in one day	DGI indicates the subject's ability to adapt walking patterns according to environmental changes (ie changes in the speed, turn the head, climb over or around obstacles or stairs). The DGI was created to assess the balance dysfunction in individuals with alterations in the way of vestibular apparatus, but it represents a reliable assessment scale for subjects with multiple sclerosis (McConvey 2005).
Unified Balance Scale - Unified Balance Scale (UBS)	one evaluation in one day	The 27 items that make up the UBS are part of the existing three scales: Berg Balance Sclale (BBS), Performance Oriented Mobility Scale (Scale and Tinetti POMA) and Fullerton Advanced Balance Scale (FABS).
Berg Balance Scale	one evaluation in one day	This scale tests static and dynamic activities. The level of each item has a score range 0-4 determined the ability of the patient to the ability to perform the task tested. The results of each item are added together, the total score is 56.

Trial Locations

Locations (1)

Ferrara University Hospital; 🇮🇹 Ferrara, Italy