NCT05641714

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 8, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

December 15, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2023

Completed
Last Updated

February 23, 2023

Status Verified

February 1, 2023

Enrollment Period

1 month

First QC Date

November 24, 2022

Last Update Submit

February 22, 2023

Conditions

Keywords

L testmultiple sclerosisfunctional mobilityreliabilityvalidity

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Timed Up and Go test

    Baseline

  • 10 meter walk test

    Baseline

  • 6 minute walk test

    Baseline

  • the timed 360° turn test

    Baseline

Study Arms (2)

multiple sclerosis

Patients with Multiple Sclerosis

Other: L testOther: Timed Up and Go testOther: 10 meter walk testOther: Six Minute Walk TestOther: The timed 360° turn test

healthy controls

healthy controls

Other: L test

Interventions

L testOTHER

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.

healthy controlsmultiple sclerosis

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.

multiple sclerosis

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.

multiple sclerosis

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.

multiple sclerosis

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

multiple sclerosis

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with Multiple Sclerosis who apply to Gazi University, Department of Physiotherapy and Rehabilitation will be invited to this study.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 25555897BACKGROUND
  • 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.

    PMID: 15982169BACKGROUND
  • Eldemir K, Eldemir S, Ozkul C, Irkec C, Guclu-Gunduz A. Reliability and validity of the L test in people with multiple sclerosis. Physiotherapy. 2025 Mar;126:101429. doi: 10.1016/j.physio.2024.101429. Epub 2024 Sep 24.

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

November 24, 2022

First Posted

December 8, 2022

Study Start

December 15, 2022

Primary Completion

January 16, 2023

Study Completion

January 16, 2023

Last Updated

February 23, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations