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OpenTrials
Completed

NCT Number: NCT04185688

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fatih Söke

Ankara, 06560, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Functional Reach Test

Other

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.

Primary outcomes

  1. Functional Reach Test

    Time frame: 30 seconds

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

Secondary outcomes

  1. Biodex Balance System

    Time frame: 2 minutes

    Biodex Balance System is used to assess limits of stability.

  2. Berg Balance Scale

    Time frame: 10 minutes

    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.

  3. Four Square Step Test

    Time frame: 20 seconds

    Four Square Step Test is used to assess dynamic balance.

  4. Timed Up and Go Test

    Time frame: 15 seconds

    Timed Up and Go Test is used to assess functional mobility.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 4, 2019
Registry last updated
May 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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