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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: 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

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 Type: Observational
• Enrollment (Actual): 68

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Gazi University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• 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:

• 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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
healthy controls	Other: L test; 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.
multiple sclerosis; Patients with Multiple Sclerosis	Other: L test; 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.; Other: Timed Up and Go test; 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.; Other: 10 meter walk test; 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.; Other: Six Minute Walk Test; 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.; Other: The timed 360° turn test; Each participant turns around in place in a standing position for both sides.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Gazi University

Publications and helpful links

General Publications

• Kim JS, Chu DY, Jeon HS. Reliability and validity of the L test in participants with chronic stroke. Physiotherapy. 2015 Jun;101(2):161-5. doi: 10.1016/j.physio.2014.09.003. Epub 2014 Oct 28.
• Deathe AB, Miller WC. The L test of functional mobility: measurement properties of a modified version of the timed "up & go" test designed for people with lower-limb amputations. Phys Ther. 2005 Jul;85(7):626-35.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2022
• Primary Completion (Actual): January 16, 2023
• Study Completion (Actual): January 16, 2023

Study Registration Dates

• First Submitted: November 24, 2022
• First Submitted That Met QC Criteria: December 7, 2022
• First Posted (Actual): December 8, 2022

Study Record Updates

• Last Update Posted (Estimate): February 23, 2023
• Last Update Submitted That Met QC Criteria: February 22, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: multiple sclerosis; validity; reliability; L test; functional mobility
• 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: 1-MS-L-Test-reliability

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