The Reliability and Validity of the Functional Reach Test in Patients With Multiple Sclerosis

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Functional Reach Test

Detailed Description

At baseline, the functional reach test, limits of stability test by using Biodex Balance System, Berg Balance Scale, four step square test, and timed up and go test was applied to the patients with Multiple Sclerosis. The functional reach test was repeated after seven days from the first application to evaluate its reliability.

• Study Type: Observational
• Enrollment (Actual): 79

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06560
    • Fatih Söke

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• other neurologic disorder,
• pregnancy,
• orthopedic problems affecting gait and stance,
• visual, auditory, orientational problems that could affect study results,
• cardiovascular, pulmonary, and humoral disease.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Reach Test	Functional Reach Test is clinically used to assess limits of stability.	30 seconds

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biodex Balance System	Biodex Balance System is used to assess limits of stability.	2 minutes
Berg Balance Scale	Berg Balance Scale is used to assess functional balance. Berg Balance Scale is a 14-item related to daily living activities that is scored between 0 and 4. The maximum score is 56 points and higher scores represent better balance.	10 minutes
Four Square Step Test	Four Square Step Test is used to assess dynamic balance.	20 seconds
Timed Up and Go Test	Timed Up and Go Test is used to assess functional mobility.	15 seconds

Collaborators and Investigators

• Sponsor: Gazi University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2019
• Primary Completion (Actual): February 7, 2020
• Study Completion (Actual): February 7, 2020

Study Registration Dates

• First Submitted: December 2, 2019
• First Submitted That Met QC Criteria: December 2, 2019
• First Posted (Actual): December 4, 2019

Study Record Updates

• Last Update Posted (Actual): May 4, 2020
• Last Update Submitted That Met QC Criteria: April 30, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Validity; Reliability; Functional reach test
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 2019-153

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No