Postural BalanceNCT02287948
Wii FIT Balance Board to Recording Balance Parameters in Multiple Sclerosis Subjects
An observational study of Postural Balance and Multiple Sclerosis, run by University Hospital of Ferrara at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Postural Balance, Multiple Sclerosis
- What is being tested?
- Nintendo Wii Fit Balance Board
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2014to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Male and female, aged > 18, < 80 years;
- healthy.
- 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.
Who cannot join
- pregnancy;
- previous diagnosis of debilitating diseases;
- previous diagnosis of orthopedic, neurological, vestibular or that may affect the balance.
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation Study for Using Wii FIT Balance Board to Recording Balance Parameters in Healthy Subjects and Multiple Sclerosis Subjects
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
Read the 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.
- Conditions
- Postural Balance, Multiple Sclerosis
- Being tested
- Nintendo Wii Fit Balance Board
- Keywords
- Balance, Multiple Sclerosis, Nintendo Wii Fit
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nintendo Wii Fit Balance BoardDevice
Clinical and instrumental evaluations carry out on the same day.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| MS subjects group | Multiple sclerosis subjects wiht mild-moderate gait disability with EDSS score not higher than 5.5 Receives: Device: Nintendo Wii Fit Balance Board | |
| Healthy subjects group | Healthy subjects age-matched with multiple sclerosis subjects. Receives: Device: Nintendo Wii Fit Balance Board |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one evaluation in one day
Secondary outcomes (4)
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.
Measured: one evaluation in one day
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).
Measured: one evaluation in one day
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.
Measured: one evaluation in one day
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).
Measured: one evaluation in one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural BalanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sofia Straudi, MD, University Hospital of Ferrara
- Investigators
- Sofia Straudi, Principal investigator, Ospedale San Giorgio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02287948
- Sponsor's protocol ID
- WII Balance Board_MS
- Status last verified
- Feb 2016
- First submitted
- 6 Nov 2014
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Study for Using Wii FIT Balance Board to Recording Balance Parameters in Healthy Subjects and Multiple Sclerosis Subjects
- ClinicalTrials.gov ID
- NCT02287948
- Acronym / sponsor ID
- WII Balance Board_MS
- Conditions
- Postural Balance, Multiple Sclerosis
- Keywords
- Balance, Multiple Sclerosis, Nintendo Wii Fit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 11 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MS subjects group | – | Device: Nintendo Wii Fit Balance BoardMultiple sclerosis subjects wiht mild-moderate gait disability with EDSS score not higher than 5.5 |
| Healthy subjects group | – | Device: Nintendo Wii Fit Balance BoardHealthy subjects age-matched with multiple sclerosis subjects. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Male and female, aged > 18, < 80 years;
- healthy.
- 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;
Key exclusion criteria (8 listed)
- pregnancy;
- previous diagnosis of debilitating diseases;
- previous diagnosis of orthopedic, neurological, vestibular or that may affect the balance.
- cognitive impairment assessed with Mini Mental Status Examination (MMSE) <24;
- neurological diseases associated with MS with possible involvement of motor functions;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nintendo Wii Fit Balance BoardClinical 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. | Device | Healthy subjects group, MS subjects group |
Primary outcome
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.
4 secondary outcomes
Timed "up and go" test (TUG)
Time frame: one evaluation in one day
Dynamic Gait Index (DGI)
Time frame: one evaluation in one day
Berg Balance Scale
Time frame: one evaluation in one day
Unified Balance Scale - Unified Balance Scale (UBS)
Time frame: one evaluation in one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sofia Straudi principal investigator
Ospedale San Giorgio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postural Balance and Multiple Sclerosis, run by University Hospital of Ferrara at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parameters related with postural balance and the chance to fall (time frame: one evaluation in one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2016.