NCT03584672

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2018

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 12, 2018

Completed
24 days until next milestone

Study Start

First participant enrolled

August 5, 2018

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2018

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2018

Completed
Last Updated

July 17, 2018

Status Verified

July 1, 2018

Enrollment Period

15 days

First QC Date

June 30, 2018

Last Update Submit

July 13, 2018

Conditions

Keywords

Multiple SclerosisStatic Balance TestBalanceReliabilityValidity

Outcome Measures

Primary Outcomes (1)

  • 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.

    5 minutes

Secondary Outcomes (5)

  • Berg Balance Scale

    15 minutes

  • Timed Up and Go Test

    1 minutes

  • Four Square Step Test

    1 minutes

  • One-leg Stance Test

    5 minutes

  • Functional Reach Test

    30 seconds

Study Arms (2)

Patients with Multiple Sclerosis

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

Other: Static Balance TestOther: Berg Balance ScaleOther: Timed Up an Go TestOther: Four Square Step TestOther: Functional Reach TestOther: One-leg Stance Test

Healthy Controls

Healthy people

Other: Static Balance Test

Interventions

Balance control is assessed by the Static Balance Test.

Healthy ControlsPatients with Multiple Sclerosis

Functional balance is assessed by the Berg Balance Scale.

Patients with Multiple Sclerosis

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

Patients with Multiple Sclerosis

Dynamic balance is assessed by the Four Square Step Test.

Patients with Multiple Sclerosis

Limits of stability is assessed by the Functional Reach Test.

Patients with Multiple Sclerosis

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

Patients with Multiple Sclerosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with Multiple Sclerosis who apply to Gazi University, Department of Physiotherapy and Rehabilitation will be invited to this study.

You may qualify if:

  • 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,

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 15641003BACKGROUND
  • 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.

    PMID: 20207785BACKGROUND
  • 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.

    PMID: 21777861BACKGROUND
  • 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.

    PMID: 24259912BACKGROUND
  • 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.

    PMID: 16754576BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Fatih Söke

    Gazi University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Arzu Güclü Gündüz

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

June 30, 2018

First Posted

July 12, 2018

Study Start

August 5, 2018

Primary Completion

August 20, 2018

Study Completion

August 30, 2018

Last Updated

July 17, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share