Skip to main content
OpenTrials
Completed

NCT Number: NCT05641714

The Reliability and Validity of the L-test in Patients With Multiple Sclerosis

Walking safely inside or outside is an important function in patients with Multiple Sclerosis (PwMS) that affects their daily life activity and participation. Loss of functional mobility is the major component of walking disorders in PwMS. Therefore, it is important to evaluate functional mobility.

Many functional mobility tests have been used for PwMS; however, these tests generally focus on walking speed and endurance. On the other hand, the L test, a variation of the timed up and go test (TUG), is a functional mobility measurement tool that extends the total walking distance to 20 meters and also requires the patients to turn both clockwise and counterclockwise.

Although L the test is an easy-to-use, short-term test method that evaluates higher-level components of functional mobility such as turns and transfers, to our knowledge, no study has systematically examined the reliability and validity of the L test in PwMS yet. In addition, the cut-off times that best discriminate PwMS from healthy people and fallers with non-fallers with Multiple Sclerosis (MS) have not been reported. Therefore, this study planned to investigate the reliability, validity, and discrimination of the L test in PwMS.

Completed

Looking for future studies?

Notify Me

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–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gazi University

Ankara, Turkey (Türkiye)

About this study

At baseline, the L test, Timed Up and Go test, 10 meter walk test, six minute walk test, and the timed 360 turn test will be applied to the Multiple Sclerosis group. The L test will be repeated after seven days after the first application in PwMS. Healthy controls are going to perform only the L test.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age at least 18 years,
  • Neurologist-diagnosed Multiple Sclerosis,
  • Expanded Disability Status Scale (EDSS) score between 0-5,
  • No MS exacerbation within the last 3 months,
  • Use of stable medication in the last 3 months.

Exclusion criteria

  • Having any vision, hearing, or perception problems that may affect the research results,
  • Having an orthopedic problem that will prevent walking and standing
  • Having a cardiovascular, pulmonary, or hormonal disorder

Treatment and study plan

L test

Other

The test includes standing up from a chair, walking in a straight line for 3 m, turning to the right, walking in a straight line for 7 m, turning around, walking back 7 m along the same line, turning to the left, walk 3 m in a straight line to the chair, and then sit down.

Timed Up and Go test

Other

The test requires the individual to stand up from an armed chair, walk 3m, turn around, walk back to the armed chair, and sit down again.

10 meter walk test

Other

In the test, the clinician measures the time taken to walk a distance of 10 m from a standing position. Participants are asked to walk along a 14 m long walkway.

Six Minute Walk Test

Other

This test measures the distance (in m) that an individual is able to walk at a comfortable speed for 6 minutes. Starting from a standing position, participants walk continuously around two pylons placed 30 m apart for 6 minutes. The distance is recorded end of the test.

The timed 360° turn test

Other

Each participant turns around in place in a standing position for both sides.

Primary outcomes

  1. L test

    Time frame: baseline

    The L test evaluates functional mobility. Higher durations indicate worse functional mobility performance.

  2. L test-second assessment

    Time frame: the second assessment will be conducted after the seven days

    The L test evaluates functional mobility. Higher durations indicate worse functional mobility performance.

Secondary outcomes

  1. Timed Up and Go test

    Time frame: Baseline

    Timed Up and Go test evaluates functional mobility. Higher durations indicate worse functional mobility.

  2. 10 meter walk test

    Time frame: Baseline

    10 meter walk test is a performance measure used to assess walking speed in meters per second over a short distance. It can be employed to determine functional mobility and gait.

  3. 6 minute walk test

    Time frame: Baseline

    This test measures the distance (in m) that an individual is able to walk at a comfortable speed for 6 minutes. Starting from a standing position, participants walk continuously around two pylons placed 30 m apart for 6 minutes. The distance is measured end of the test.

  4. the timed 360° turn test

    Time frame: Baseline

    The timed 360° turn test is an easily administered, not time-consuming, and specific measurement tool to assess turning ability. It measures the time taken for an individual to 360° turn around in a standing position. The timed 360° turn test is also correlated with balance and functional mobility.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 8, 2022
Registry last updated
Feb 23, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.