Clinical trial NCT04185688: The Reliability and Validity of the Functional Reach Test in Patients With Multiple Sclerosis
Official title: The Reliability and Validity of the Functional Reach Test in Patients With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Functional reach test
Reliability
Validity
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2019-12-04
Enrollment: 79
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: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Functional Reach Test
timeFrame: 30 seconds
Secondary outcomes:
measure: Biodex Balance System
timeFrame: 2 minutes
measure: Berg Balance Scale
timeFrame: 10 minutes
measure: Four Square Step Test
timeFrame: 20 seconds
measure: Timed Up and Go Test
timeFrame: 15 seconds
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Fatih Söke
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.