Clinical trial NCT03584672: The Reliability, Validity, and Responsiveness of the Static Balance Test in Patients With Multiple Sclerosis.
Official title: The Reliability, Validity, and Responsiveness of the Static Balance Test in Patients With Multiple Sclerosis.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Static Balance Test
Balance
Reliability
Validity
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2018-07-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Multiple Sclerosis who apply to Gazi University, Department of Physiotherapy and Rehabilitation will be invited to this study.

Brief summary: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Static Balance Test
timeFrame: 5 minutes
Secondary outcomes:
measure: Berg Balance Scale
timeFrame: 15 minutes
measure: Timed Up and Go Test
timeFrame: 1 minutes
measure: Four Square Step Test
timeFrame: 1 minutes
measure: One-leg Stance Test
timeFrame: 5 minutes
measure: Functional Reach Test
timeFrame: 30 seconds
Other outcomes:
Locations:
Study officials:
affiliation: Gazi University
name: Fatih Söke
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.