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

NCT02287948 | Completed DMC

• 1 other identifier: WII Balance Board_MS
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Postural Balance; Multiple Sclerosis

Keywords

Balance; Multiple Sclerosis; Nintendo Wii Fit

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Timed "up and go" test (TUG)

  one evaluation in one day

• Dynamic Gait Index (DGI)

  one evaluation in one day

• Berg Balance Scale

  one evaluation in one day

• Unified Balance Scale - Unified Balance Scale (UBS)

  one evaluation in one day

Study Arms (2)

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

Healthy subjects group

Healthy subjects age-matched with multiple sclerosis subjects.

Device: Nintendo Wii Fit Balance Board

Interventions

Nintendo Wii Fit Balance Board DEVICE

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; MS subjects group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• pregnancy;
• previous diagnosis of debilitating diseases;
• previous diagnosis of orthopedic, neurological, vestibular or that may affect the balance.
• 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.
• 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;

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (1)

Ferrara University Hospital

Ferrara, Ferrara, 44124, Italy

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Sofia Straudi

  Ospedale San Giorgio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 6, 2014
• First Posted: November 11, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: February 3, 2016

Record last verified: 2016-02

Locations

IT (1)