Multiple SclerosisNCT05641714
The Reliability and Validity of the L-test in Patients With Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Gazi University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- L test, Timed Up and Go test and 10 meter walk test
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2022to 16 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Multiple Sclerosis who apply to Gazi University, Department of Physiotherapy and Rehabilitation will be invited to this study.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- L test, Timed Up and Go test, 10 meter walk test, Six Minute Walk Test, The timed 360° turn test
- Keywords
- L test, multiple sclerosis, functional mobility, reliability, validity
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Timed Up and Go testOther
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 testOther
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 TestOther
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 testOther
Each participant turns around in place in a standing position for both sides.
| Study group | Role | What they receive |
|---|---|---|
| multiple sclerosis | Patients with Multiple Sclerosis Receives: 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 | |
| healthy controls | healthy controls Receives: Other: L test |
What is being measured
The primary outcome is the main question the study is designed to answer.
L test
The L test evaluates functional mobility. Higher durations indicate worse functional mobility performance.
Measured: baseline
L test-second assessment
The L test evaluates functional mobility. Higher durations indicate worse functional mobility performance.
Measured: the second assessment will be conducted after the seven days
Secondary outcomes (4)
Timed Up and Go test
Timed Up and Go test evaluates functional mobility. Higher durations indicate worse functional mobility.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start15 Dec 2022
- Primary completion16 Jan 2023
- Study completion16 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kader Eldemir, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05641714
- Sponsor's protocol ID
- 1-MS-L-Test-reliability
- Status last verified
- Feb 2023
- First submitted
- 24 Nov 2022
- Last updated
- 23 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 25555897Deathe 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.
PubMed 15982169Eldemir 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.
PubMed 39541755
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reliability and Validity of the L-test in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05641714
- Acronym / sponsor ID
- 1-MS-L-Test-reliability
- Conditions
- Multiple Sclerosis
- Keywords
- L test, multiple sclerosis, functional mobility, reliability, validity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 16 Jan 2023 (actual)
- Study completion
- 16 Jan 2023 (actual)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| multiple sclerosis | – | Other: L test, Other: Timed Up and Go test, Other: 10 meter walk test, Other: Six Minute Walk Test, Other: The timed 360° turn testPatients with Multiple Sclerosis |
| healthy controls | – | Other: L testhealthy controls |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Multiple Sclerosis who apply to Gazi University, Department of Physiotherapy and Rehabilitation will be invited to this study.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L testThe 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 | healthy controls, multiple sclerosis |
| Timed Up and Go testThe 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 | multiple sclerosis |
| 10 meter walk testIn 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 | multiple sclerosis |
| Six Minute Walk TestThis 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 | multiple sclerosis |
| The timed 360° turn testEach participant turns around in place in a standing position for both sides. | Other | multiple sclerosis |
Primary outcome
L test
Time frame: baseline
The L test evaluates functional mobility. Higher durations indicate worse functional mobility performance.
L test-second assessment
Time frame: the second assessment will be conducted after the seven days
The L test evaluates functional mobility. Higher durations indicate worse functional mobility performance.
4 secondary outcomes
Timed Up and Go test
Time frame: Baseline
10 meter walk test
Time frame: Baseline
6 minute walk test
Time frame: Baseline
the timed 360° turn test
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Background: PubMed 25555897Kim 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.
- Background: PubMed 15982169Deathe 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.
- Derived from this study: PubMed 39541755Eldemir 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
L test (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05641714, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2023.