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

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: L test; Other: Timed Up and Go test; Other: 10 meter walk test; Other: Six Minute Walk Test; Other: The timed 360° turn test

• Registration Number: NCT05641714
• Lead Sponsor: Gazi University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-11-24
• Study First Submitted QC: 2022-12-07
• Study First Posted: 2022-12-08
• Study Start: 2022-12-15
• Primary Completion: 2023-01-16
• Study Completion: 2023-01-16
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-22
• Last Update Posted: 2023-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
multiple sclerosis	10 meter walk test	Patients with Multiple Sclerosis
multiple sclerosis	The timed 360° turn test	Patients with Multiple Sclerosis
multiple sclerosis	L test	Patients with Multiple Sclerosis
multiple sclerosis	Timed Up and Go test	Patients with Multiple Sclerosis
multiple sclerosis	Six Minute Walk Test	Patients with Multiple Sclerosis
healthy controls	L test	healthy controls

Primary Outcome Measures

Name	Time	Method
L test	baseline	The L test evaluates functional mobility. Higher durations indicate worse functional mobility performance.
L test-second assessment	the second assessment will be conducted after the seven days	The L test evaluates functional mobility. Higher durations indicate worse functional mobility performance.

Secondary Outcome Measures

Name	Time	Method
the timed 360° turn test	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.
6 minute walk test	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.
Timed Up and Go test	Baseline	Timed Up and Go test evaluates functional mobility. Higher durations indicate worse functional mobility.
10 meter walk test	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.

Trial Locations

Locations (1)

Gazi University; 🇹🇷 Ankara, Turkey