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

Multiple Sclerosis Clinical Trial

Official title:

Validation Study for Using Wii FIT Balance Board to Recording Balance Parameters in Healthy Subjects and Multiple Sclerosis Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02287948
• Other study ID #: WII Balance Board_MS
• Status: Completed
• Phase: N/A
• First received: November 6, 2014
• Last updated: February 2, 2016
• Start date: September 2014
• Est. completion date: January 2016

Study information

• Verified date: February 2016
• Source: University Hospital of Ferrara
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria (Healthy subjects):

• Male and female, aged > 18, < 80 years;

• healthy.

Exclusion Criteria (Healthy subjects):

• pregnancy;

• previous diagnosis of debilitating diseases;

• previous diagnosis of orthopedic, neurological, vestibular or that may affect the balance.

Inclusion Criteria (Multiple Sclerosis subjects):

• Male and female, aged > 18, < 80 years;

• subjects with a diagnosis of MS according to the McDonald criteria in course with relapse and remission, progressive, primary or secondary are included in the study;

• absence of disease exacerbations in the 3 months prior to enrollment;

• mild or moderate gait disability identified with the Expanded Disability Status Scale (EDSS) score not higher than 5.5. This degree of severity refers to a subject with restriction ambulatory activity but which does not require constantly an unilateral support (stick, crutch, other) for walking.

Exclusion Criteria (Multiple Sclerosis subjects):

• cognitive impairment assessed with Mini Mental Status Examination (MMSE) <24;

• neurological diseases associated with MS with possible involvement of motor functions;

• of internal conditions that might interfere with the ability to complete the study protocol in a secure manner;

• severe cognitive-behavioral (score less than 24 on the Mini Mental Status Examination);

• pregnancy;

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Multiple Sclerosis
• Postural Balance
• Sclerosis

Intervention

Device:
• Nintendo Wii Fit Balance Board
Clinical and instrumental evaluations carry out on the same day. 1) Instrumental evaluations All subjects (healthy + MS) will ask to 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.

Locations

Country	Name	City	State
Italy	Ferrara University Hospital	Ferrara

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Ferrara

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parameters related with postural balance and the chance to fall	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.	one evaluation in one day	No
Secondary	Timed "up and go" test (TUG)	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.	one evaluation in one day	No
Secondary	Dynamic Gait Index (DGI)	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).	one evaluation in one day	No
Secondary	Berg Balance Scale	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.	one evaluation in one day	No
Secondary	Unified Balance Scale - Unified Balance Scale (UBS)	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).	one evaluation in one day	No