Multiple SclerosisNCT03584672
The Reliability, Validity, and Responsiveness of the Static Balance Test in Patients With Multiple Sclerosis.
An observational study of Multiple Sclerosis, run by Gazi University.
Trial summary
The aim of the study is to investigate reliability, validity, and responsiveness of the Static Balance Test in patients with Multiple Sclerosis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Static Balance Test, Berg Balance Scale and Timed Up an Go Test
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 5 Aug 2018to 30 Aug 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Multiple Sclerosis who apply to Gazi University, Department of Physiotherapy and Rehabilitation will be invited to this study.
Who may be able to join
- at least 18 years,
- neurologist-diagnosed Multiple Sclerosis,
- Expanded Disability Status Scale (EDSS) score < 7,
- able to walk 10 m with or without aids,
- no MS exacerbation within the last 2 months,
- use of stable medication in the last 2 months,
Who cannot join
- other neurologic disorder,
- Pregnancy,
- orhopedic problems iaffecting gait and stance,
- visual, auditory, orientational problems that could affect study results,
- Cardiovascular, pulmonary, and humoral disease.
Trial locations and contacts
No sites are listed yet.
Arzu Güclü Gündüz contact
About this study
The aim of the study is to investigate reliability, validity, and responsiveness of the Static Balance Test in patients with Multiple Sclerosis.
Read the detailed description
At baseline, the Static Balance Test, Berg Balance Scale, Timed Up and Go test, Functional Reach Test, Four Square Step Test, and One-legged Stance Test is applied to the Multiple Sclerosis group. The Static Balance Test is repeated after seven days from the first application in patients with Multiple Sclerosis. Healthy controls are going to perform only the Static Balance Test.
- Conditions
- Multiple Sclerosis
- Being tested
- Static Balance Test, Berg Balance Scale, Timed Up an Go Test, Four Square Step Test, Functional Reach Test
- Keywords
- Multiple Sclerosis, Static Balance Test, Balance, Reliability, Validity
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Static Balance TestOther
Balance control is assessed by the Static Balance Test.
Berg Balance ScaleOther
Functional balance is assessed by the Berg Balance Scale.
Timed Up an Go TestOther
Functional mobility is assessed by the Timed Up and Go test.
Four Square Step TestOther
Dynamic balance is assessed by the Four Square Step Test.
Functional Reach TestOther
Limits of stability is assessed by the Functional Reach Test.
One-leg Stance TestOther
Postural steadiness is assessed by the One-leg Stance Test.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Multiple Sclerosis | Patients with Multiple Sclerosis (Expanded Disability Status Scale (EDSS) score < 7) Receives: Other: Static Balance Test; Other: Berg Balance Scale; Other: Timed Up an Go Test; Other: Four Square Step Test; Other: Functional Reach Test; Other: One-leg Stance Test | |
| Healthy Controls | Healthy people Receives: Other: Static Balance Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static Balance Test
The Static Balance Test is used to assess balance control. The Static Balance Test, consists of five posture-holding tasks (sitting, stride standing, close standing, one-foot standing on the unparalyzed leg, and one-foot standing on the paralyzed leg). Four grades, 1-4, are used to judge the ability of patients to hold these postures. The grade at which a subject is rated on a task is taken as the score for that task.
Hence, the minimum Static Balance Test score is 5, and the maximum is 20. A higher score indicates better balance.
Measured: 5 minutes
Secondary outcomes (5)
Berg Balance Scale
Functional balance is assessed by using the Berg Balance Scale. During the test, participants are asked to perform 14 tasks frequently used in daily life activities. Each item is scored between 0 (unable to perform the task) and 4 (task is performed independently) according to the ability of the person while performing the task. The highest possible score is 56 points. A higher score indicates better balance.
Measured: 15 minutes
Timed Up and Go Test
Functional mobility is assessed by using the timed up and go test. The timed up and go test measures the time that a patient needs to stand up from a chair, walk a 3-m distance, come back and sit back on the chair. A lower score indicates better functional mobility.
Measured: 1 minutes
Four Square Step Test
The Four Square Step Test measures dynamic balance and clinically assesses the person's ability to step over objects forward, sideways, and backward. A square was formed by 4 canes resting flat on the floor. The participants were instructed to try and complete the sequence as fast as possible without touching the canes with both feet, making contact with the floor in each square. A lower score indicates better dynamic balance.
Measured: 1 minutes
One-leg Stance Test
The clinical test of One-leg Stance Test assesses postural steadiness in a static position by a quantitative measurement i.e. the number of seconds a person can maintain the One-leg Stance Test position, thus implying that better postural steadiness would allow for longer standing on one leg.
Measured: 5 minutes
Functional Reach Test
The Functional Reach Test assesses balance by measuring the limits while the patient reaches forwards as far as possible, having the arms in 90° flexion and without lifting the heels off the floor. A higher score indicates better limits of stability.
Measured: 30 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start5 Aug 2018 (estimated)
- Primary completion20 Aug 2018 (estimated)
- Study completion30 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih Söke, Gazi University
- Investigators
- Fatih Söke, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03584672
- Sponsor's protocol ID
- 322
- Status last verified
- Jul 2018
- First submitted
- 30 Jun 2018
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McConvey J, Bennett SE. Reliability of the Dynamic Gait Index in individuals with multiple sclerosis. Arch Phys Med Rehabil. 2005 Jan;86(1):130-3. doi: 10.1016/j.apmr.2003.11.033.
PubMed 15641003Gijbels D, Alders G, Van Hoof E, Charlier C, Roelants M, Broekmans T, Eijnde BO, Feys P. Predicting habitual walking performance in multiple sclerosis: relevance of capacity and self-report measures. Mult Scler. 2010 May;16(5):618-26. doi: 10.1177/1352458510361357. Epub 2010 Mar 5.
PubMed 20207785Matsuda PN, Shumway-Cook A, Bamer AM, Johnson SL, Amtmann D, Kraft GH. Falls in multiple sclerosis. PM R. 2011 Jul;3(7):624-32; quiz 632. doi: 10.1016/j.pmrj.2011.04.015.
PubMed 21777861Suzuki M, Fujisawa H, Machida Y, Minakata S. Relationship between the Berg Balance Scale and Static Balance Test in Hemiplegic Patients with Stroke. J Phys Ther Sci. 2013 Aug;25(8):1043-9. doi: 10.1589/jpts.25.1043. Epub 2013 Sep 20.
PubMed 24259912Cattaneo D, Regola A, Meotti M. Validity of six balance disorders scales in persons with multiple sclerosis. Disabil Rehabil. 2006 Jun 30;28(12):789-95. doi: 10.1080/09638280500404289.
PubMed 16754576
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reliability, Validity, and Responsiveness of the Static Balance Test in Patients With Multiple Sclerosis.
- ClinicalTrials.gov ID
- NCT03584672
- Acronym / sponsor ID
- 322
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Static Balance Test, Balance, Reliability, Validity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 5 Aug 2018 (estimated)
- Primary completion
- 20 Aug 2018 (estimated)
- Study completion
- 30 Aug 2018 (estimated)
- First posted
- 12 Jul 2018 (actual)
- 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.
The aim of the study is to investigate reliability, validity, and responsiveness of the Static Balance Test in patients with Multiple Sclerosis.
Detailed description
At baseline, the Static Balance Test, Berg Balance Scale, Timed Up and Go test, Functional Reach Test, Four Square Step Test, and One-legged Stance Test is applied to the Multiple Sclerosis group. The Static Balance Test is repeated after seven days from the first application in patients with Multiple Sclerosis. Healthy controls are going to perform only the Static Balance Test.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Multiple Sclerosis | – | Other: Static Balance Test, Other: Berg Balance Scale, Other: Timed Up an Go Test, Other: Four Square Step Test, Other: Functional Reach Test, Other: One-leg Stance TestPatients with Multiple Sclerosis (Expanded Disability Status Scale (EDSS) score < 7) |
| Healthy Controls | – | Other: Static Balance TestHealthy people |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Multiple Sclerosis who apply to Gazi University, Department of Physiotherapy and Rehabilitation will be invited to this study.
Key inclusion criteria (6 listed)
- at least 18 years,
- neurologist-diagnosed Multiple Sclerosis,
- Expanded Disability Status Scale (EDSS) score < 7,
- able to walk 10 m with or without aids,
- no MS exacerbation within the last 2 months,
Key exclusion criteria (5 listed)
- other neurologic disorder,
- Pregnancy,
- orhopedic problems iaffecting gait and stance,
- visual, auditory, orientational problems that could affect study results,
- Cardiovascular, pulmonary, and humoral disease.
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 |
|---|---|---|
| Static Balance TestBalance control is assessed by the Static Balance Test. | Other | Healthy Controls, Patients with Multiple Sclerosis |
| Berg Balance ScaleFunctional balance is assessed by the Berg Balance Scale. | Other | Patients with Multiple Sclerosis |
| Timed Up an Go TestFunctional mobility is assessed by the Timed Up and Go test. | Other | Patients with Multiple Sclerosis |
| Four Square Step TestDynamic balance is assessed by the Four Square Step Test. | Other | Patients with Multiple Sclerosis |
| Functional Reach TestLimits of stability is assessed by the Functional Reach Test. | Other | Patients with Multiple Sclerosis |
| One-leg Stance TestPostural steadiness is assessed by the One-leg Stance Test. | Other | Patients with Multiple Sclerosis |
Primary outcome
Static Balance Test
Time frame: 5 minutes
The Static Balance Test is used to assess balance control. The Static Balance Test, consists of five posture-holding tasks (sitting, stride standing, close standing, one-foot standing on the unparalyzed leg, and one-foot standing on the paralyzed leg). Four grades, 1-4, are used to judge the ability of patients to hold these postures. The grade at which a subject is rated on a task is taken as the score for that task. Hence, the minimum Static Balance Test score is 5, and the maximum is 20. A higher score indicates better balance.
5 secondary outcomes
Berg Balance Scale
Time frame: 15 minutes
Timed Up and Go Test
Time frame: 1 minutes
Four Square Step Test
Time frame: 1 minutes
One-leg Stance Test
Time frame: 5 minutes
Functional Reach Test
Time frame: 30 seconds
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
- Background: PubMed 15641003McConvey J, Bennett SE. Reliability of the Dynamic Gait Index in individuals with multiple sclerosis. Arch Phys Med Rehabil. 2005 Jan;86(1):130-3. doi: 10.1016/j.apmr.2003.11.033.
- Background: PubMed 20207785Gijbels D, Alders G, Van Hoof E, Charlier C, Roelants M, Broekmans T, Eijnde BO, Feys P. Predicting habitual walking performance in multiple sclerosis: relevance of capacity and self-report measures. Mult Scler. 2010 May;16(5):618-26. doi: 10.1177/1352458510361357. Epub 2010 Mar 5.
- Background: PubMed 21777861Matsuda PN, Shumway-Cook A, Bamer AM, Johnson SL, Amtmann D, Kraft GH. Falls in multiple sclerosis. PM R. 2011 Jul;3(7):624-32; quiz 632. doi: 10.1016/j.pmrj.2011.04.015.
- Background: PubMed 24259912Suzuki M, Fujisawa H, Machida Y, Minakata S. Relationship between the Berg Balance Scale and Static Balance Test in Hemiplegic Patients with Stroke. J Phys Ther Sci. 2013 Aug;25(8):1043-9. doi: 10.1589/jpts.25.1043. Epub 2013 Sep 20.
- Background: PubMed 16754576Cattaneo D, Regola A, Meotti M. Validity of six balance disorders scales in persons with multiple sclerosis. Disabil Rehabil. 2006 Jun 30;28(12):789-95. doi: 10.1080/09638280500404289.
- Individual participant dataSharing planned: No
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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.
Arzu Güclü Gündüz contact
Fatih Söke principal investigator
Gazi University
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Gazi University.
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 5 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: status not confirmed, as of the sponsor's last update on 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Faith Söke (+90 506 932 81 02, fthsk_8993@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static Balance Test (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03584672, which also lists 5 linked publications.
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 17 Jul 2018.