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

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ClinicalTrials.gov Identifier: NCT02287948
Recruitment Status : Completed
First Posted : November 11, 2014
Last Update Posted : February 3, 2016
Sponsor:
Information provided by (Responsible Party):
Sofia Straudi, MD, 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


Condition or disease Intervention/treatment
Postural Balance Multiple Sclerosis Device: Nintendo Wii Fit Balance Board

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.


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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Validation Study for Using Wii FIT Balance Board to Recording Balance Parameters in Healthy Subjects and Multiple Sclerosis Subjects
Study Start Date : September 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
MS subjects group
Multiple sclerosis subjects wiht mild-moderate gait disability with EDSS score not higher than 5.5
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.


Healthy subjects group
Healthy subjects age-matched with multiple sclerosis subjects.
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.





Primary Outcome Measures :
  1. Parameters related with postural balance and the chance to fall [ Time Frame: 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 :
  1. Timed "up and go" test (TUG) [ Time Frame: 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.

  2. Dynamic Gait Index (DGI) [ Time Frame: 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).

  3. Berg Balance Scale [ Time Frame: 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.

  4. Unified Balance Scale - Unified Balance Scale (UBS) [ Time Frame: 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).



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Will be recruited 20 healthy subjects and 20 subject with a diagnosis of multiple sclerosis and mild to moderate disability ambulatory identified with a value not higher than 5.5 EDSS score. The subjects of both groups will be age-matched to exclude differences caused by age posturographic. All individuals carry out the task of torque balance both on the platform and on the Wii Fit Balance Board on the same day.
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02287948


Locations
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Italy
Ferrara University Hospital
Ferrara, Italy, 44124
Sponsors and Collaborators
University Hospital of Ferrara
Investigators
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Principal Investigator: Sofia Straudi Ospedale San Giorgio

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Responsible Party: Sofia Straudi, MD, MD, University Hospital of Ferrara
ClinicalTrials.gov Identifier: NCT02287948     History of Changes
Other Study ID Numbers: WII Balance Board_MS
First Posted: November 11, 2014    Key Record Dates
Last Update Posted: February 3, 2016
Last Verified: February 2016
Keywords provided by Sofia Straudi, MD, University Hospital of Ferrara:
Balance
Multiple Sclerosis
Nintendo Wii Fit
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases