NCT04185688

Brief Summary

Loss of limits of stability ability is one of the major components of balance dysfunction in MS. The functional reach test is quick and clinically available tool for assessing limits of stability but reliability and validity of this test has not yet been systematically examined in people with Multiple Sclerosis.The aim of the study is to investigate reliability and validity of the functional reach test in patients with Multiple Sclerosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
79

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

December 2, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 4, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

December 6, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2020

Completed
Last Updated

May 4, 2020

Status Verified

April 1, 2020

Enrollment Period

2 months

First QC Date

December 2, 2019

Last Update Submit

April 30, 2020

Conditions

Keywords

Multiple SclerosisFunctional reach testReliabilityValidity

Outcome Measures

Primary Outcomes (1)

  • Functional Reach Test

    Functional Reach Test is clinically used to assess limits of stability.

    30 seconds

Secondary Outcomes (4)

  • Biodex Balance System

    2 minutes

  • Berg Balance Scale

    10 minutes

  • Four Square Step Test

    20 seconds

  • Timed Up and Go Test

    15 seconds

Study Arms (2)

Multiple Sclerosis

Functional Reach Test: It measures the maximum distance an individual is able to reach forward beyond arm's length in the standing position when maintaining a fixed base of support. Biodex Balance System: Biodex Balance System is used to evaluate limits of stability. The limits of stability test consists of standing on the platform and leaning in eight directions to make a cursor displayed on the system's screen hit a target. Berg Balance Scale: It has 14 items, each of which is scored from 0 (i.e, severely impaired balance) to 4 (i.e., no balance impairment). Timed Up and Go test: It requires individual to stand up from an armed chair, walk 3m, turn around, walk back to the armed chair, and sit down again. Four square step test: It requires an individual to step over obstacles in various directions including forward, backward, and sideways.

Other: Functional Reach Test

Healthy People

Functional Reach Test: It measures the maximum distance an individual is able to reach forward beyond arm's length in the standing position when maintaining a fixed base of support.

Other: Functional Reach Test

Interventions

The Functional Reach Test assesses balance by measuring the limits of stability while the patient reaches forwards as far as possible, having the arms in 90° flexion and without lifting the heels off the floor.

Healthy PeopleMultiple 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 20 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,
  • orthopedic problems affecting 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

Study Sites (1)

Fatih Söke

Ankara, 06560, Turkey (Türkiye)

Location

Related Publications (7)

  • Ganesan M, Kanekar N, Aruin AS. Direction-specific impairments of limits of stability in individuals with multiple sclerosis. Ann Phys Rehabil Med. 2015 Jun;58(3):145-50. doi: 10.1016/j.rehab.2015.04.002. Epub 2015 May 8.

    PMID: 25960358BACKGROUND
  • Cameron MH, Nilsagard Y. Balance, gait, and falls in multiple sclerosis. Handb Clin Neurol. 2018;159:237-250. doi: 10.1016/B978-0-444-63916-5.00015-X.

    PMID: 30482317BACKGROUND
  • Martins EF, de Menezes LT, de Sousa PH, de Araujo Barbosa PH, Costa AS. Reliability of the Functional Reach Test and the influence of anthropometric characteristics on test results in subjects with hemiparesis. NeuroRehabilitation. 2012;31(2):161-9. doi: 10.3233/NRE-2012-0786.

    PMID: 22951711BACKGROUND
  • Katz-Leurer M, Fisher I, Neeb M, Schwartz I, Carmeli E. Reliability and validity of the modified functional reach test at the sub-acute stage post-stroke. Disabil Rehabil. 2009;31(3):243-8. doi: 10.1080/09638280801927830.

    PMID: 18608433BACKGROUND
  • Lynch SM, Leahy P, Barker SP. Reliability of measurements obtained with a modified functional reach test in subjects with spinal cord injury. Phys Ther. 1998 Feb;78(2):128-33. doi: 10.1093/ptj/78.2.128.

    PMID: 9474105BACKGROUND
  • Duncan PW, Studenski S, Chandler J, Prescott B. Functional reach: predictive validity in a sample of elderly male veterans. J Gerontol. 1992 May;47(3):M93-8. doi: 10.1093/geronj/47.3.m93.

    PMID: 1573190BACKGROUND
  • Duncan PW, Weiner DK, Chandler J, Studenski S. Functional reach: a new clinical measure of balance. J Gerontol. 1990 Nov;45(6):M192-7. doi: 10.1093/geronj/45.6.m192.

    PMID: 2229941BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

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

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

December 2, 2019

First Posted

December 4, 2019

Study Start

December 6, 2019

Primary Completion

February 7, 2020

Study Completion

February 7, 2020

Last Updated

May 4, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations