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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05641714
• Other study ID #: 1-MS-L-Test-reliability
• Status: Completed
• Start date: December 15, 2022
• Est. completion date: January 16, 2023

Study information

• Verified date: February 2023
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: January 16, 2023
• Est. primary completion date: January 16, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.
• 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.
• 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.
• 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.
• The timed 360° turn test
Each participant turns around in place in a standing position for both sides.

Locations

Country	Name	City	State
Turkey	Gazi University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	L test	The L test evaluates functional mobility. Higher durations indicate worse functional mobility performance.	baseline
Primary	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	Timed Up and Go test	Timed Up and Go test evaluates functional mobility. Higher durations indicate worse functional mobility.	Baseline
Secondary	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
Secondary	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
Secondary	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