The Reliability, Validity, and Responsiveness of the Static Balance Test in Patients With Multiple Sclerosis.

NCT ID: NCT03584672

Last Updated: 2018-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-05

Study Completion Date

2018-08-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of the study is to investigate reliability, validity, and responsiveness of the Static Balance Test in patients with Multiple Sclerosis.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Sclerosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with Multiple Sclerosis

Patients with Multiple Sclerosis (Expanded Disability Status Scale (EDSS) score \< 7)

Static Balance Test

Intervention Type OTHER

Balance control is assessed by the Static Balance Test.

Berg Balance Scale

Intervention Type OTHER

Functional balance is assessed by the Berg Balance Scale.

Timed Up an Go Test

Intervention Type OTHER

Functional mobility is assessed by the Timed Up and Go test.

Four Square Step Test

Intervention Type OTHER

Dynamic balance is assessed by the Four Square Step Test.

Functional Reach Test

Intervention Type OTHER

Limits of stability is assessed by the Functional Reach Test.

One-leg Stance Test

Intervention Type OTHER

Postural steadiness is assessed by the One-leg Stance Test.

Healthy Controls

Healthy people

Static Balance Test

Intervention Type OTHER

Balance control is assessed by the Static Balance Test.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Static Balance Test

Balance control is assessed by the Static Balance Test.

Intervention Type OTHER

Berg Balance Scale

Functional balance is assessed by the Berg Balance Scale.

Intervention Type OTHER

Timed Up an Go Test

Functional mobility is assessed by the Timed Up and Go test.

Intervention Type OTHER

Four Square Step Test

Dynamic balance is assessed by the Four Square Step Test.

Intervention Type OTHER

Functional Reach Test

Limits of stability is assessed by the Functional Reach Test.

Intervention Type OTHER

One-leg Stance Test

Postural steadiness is assessed by the One-leg Stance Test.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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,

Exclusion Criteria

* other neurologic disorder,
* Pregnancy,
* orhopedic problems iaffecting gait and stance,
* visual, auditory, orientational problems that could affect study results,
* Cardiovascular, pulmonary, and humoral disease.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Gazi University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Fatih Söke

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Fatih Söke

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Faith Söke

Role: CONTACT

+90 506 932 81 02

Arzu Güclü Gündüz

Role: CONTACT

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 15641003 (View on PubMed)

Gijbels 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.

Reference Type BACKGROUND
PMID: 20207785 (View on PubMed)

Matsuda 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.

Reference Type BACKGROUND
PMID: 21777861 (View on PubMed)

Suzuki 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.

Reference Type BACKGROUND
PMID: 24259912 (View on PubMed)

Cattaneo 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.

Reference Type BACKGROUND
PMID: 16754576 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

322

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.