Clinical trial NCT05641714: The Reliability and Validity of the L-test in Patients With Multiple Sclerosis
Official title: The Reliability and Validity of the L-test in Patients With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: L test
multiple sclerosis
functional mobility
reliability
validity
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2022-12-08
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: L test
timeFrame: baseline
measure: L test-second assessment
timeFrame: the second assessment will be conducted after the seven days
Secondary outcomes:
measure: Timed Up and Go test
timeFrame: Baseline
measure: 10 meter walk test
timeFrame: Baseline
measure: 6 minute walk test
timeFrame: Baseline
measure: the timed 360° turn test
timeFrame: Baseline
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
References:
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.
citation: 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.