L Test in Multiple Sclerosis

April 6, 2022 updated by: Furkan BİLEK, Firat University

Validity and Reliability of L Test in Persons With Multiple Sclerosis

Multiple Sclerosis (MS), a chronic inflammatory disease of the central nervous system, is a disease characterized by myelin, oligodendrocyte and axon damage [1]. Research continues on the autoimmune, infectious, environmental, vascular and genetic origins of this disease, which affects approximately 2.5 million people in the world and is seen 2-3 times more in women than in men. Although the signs and symptoms of the disease vary according to the location of the lesion; Loss of balance and strength, spasticity, sensory disturbances, fatigue, ataxia, autonomic dysfunction, and decreased visual acuity is frequently observed.

There are no studies in the literature investigating the validity and reliability of this test in individuals with MS. Reliability is population-specific and it is important to investigate the reliability of the L test in MS patients. Therefore, the aim of our study is to reveal the test-retest reliability and validity of the L test.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

General Information about the Research, Rationale and Objectives:

Multiple Sclerosis (MS), a chronic inflammatory disease of the central nervous system, is a disease characterized by myelin, oligodendrocyte and axon damage [1]. Research continues on the autoimmune, infectious, environmental, vascular and genetic origins of this disease, which affects approximately 2.5 million people in the world and is seen 2-3 times more in women than in men [1, 2]. Although the signs and symptoms of the disease vary according to the location of the lesion; Loss of balance and strength, spasticity, sensory disturbances, fatigue, ataxia, autonomic dysfunction, and decreased visual acuity are frequently observed [1].

Abnormalities and losses in balance management are frequently seen in individuals with MS [3-6] . This abnormality, together with other risk factors, increases the risk of falling [7] and causes limitations in patients' activities of daily living. Studies on balance problems in elderly individuals are frequently investigated in the literature. However, the frequency of falls in this population was found to be 1.5 falls per year [8], while another study investigating individuals with MS found an average of 9 falls per year [7]. In order to develop fall prevention or reduction strategies, it is necessary to evaluate different aspects of motor impairment and to accurately identify factors contributing to falls [9-11]. Since falls among MS patients have a multifactorial etiology, multiple evaluations are necessary to explore the balance problem.

Although various scales have been developed to evaluate the functional level of MS patients [12, 13], the use of frequently applied scales in this patient group allows the results to be compared with other studies and other pathologies. In addition, the use of frequently applied scales does not require special training of raters. Previous studies have used the Berg Balance Scale, the Functional Reach Test, the Timed Get Up and Walk test, and general measures of fall risk (eg, questioning the date of fall) [14-16]. These tests primarily assess the ability to walk forward, turn back, and take a step.

The reliability of the TUG in people with MS has ranged from 'good' to 'excellent' [17,18], but the TUG is only an opportunity for unilateral disorders to turn in a preferred direction [19]. Thus, despite good reliability and validity, TUG currently has limitations in MS that can only be overcome by adding complex and potentially excessively expensive instrumentation. The L test is a modification of the TUG that extends the walking distance from 6 to 20 m and also requires participants to make both clockwise and counterclockwise turns. Therefore, it may have limited sensitivity and the potential to overcome ceiling effects. The L test was originally designed for individuals following lower limb amputation and has since been evaluated in stroke and hospitalized elderly subjects [19-21]. In all three studies, the L test showed good reliability and also showed good correlation with the TUG. The aim of this study is to evaluate the L test in terms of test/retest reliability and concurrent validity with TUG in individuals with MS. There are no studies in the literature investigating the validity and reliability of this test in individuals with MS. Reliability is population specific and it is important to investigate the reliability of the L test in MS patients. Therefore, the aim of our study is to reveal the test-retest reliability and validity of the L test.

10. Detailed Material and Methodology of the Research: The methodological model of the study is the validity and reliability study. Our study will include individuals who applied to Fırat University Training and Research Hospital after ethical approval and were diagnosed with Relapsin-Remitting MS by a neurologist. It is planned to collect the Helsinki Declaration on a voluntary basis from individuals whose data meet the inclusion criteria. As demographic characteristics; The age, gender, body weight, height, EDSS score, occupation and education level of the patients, the history of the disease, the number of falls in the last year and the type of MS will be recorded. Inclusion criteria for volunteers; Individuals with relapsing-remitting type MS, who are between 18-65, EDSS scores between 1 ≤ and ≤ 5.5, individuals who score 24 and above in Mini Mental State Examination and who can walk a minimum of 20 m independently will be included. In addition, exclusion criteria for volunteers; Severe spasticity of the lower extremities (Ashworth score 3 or 4), having an acute MS attack or a history of an attack in the last 1 month, having an orthopedic or systemic problem that would prevent participation in the tests, having another neuromuscular disorder other than MS, visual involvement or diplopia, and is that he has a cardio-pulmonary problem that will prevent him from participating in the tests.

Our study will be carried out as a "test-retest" design and the psychometric properties of the L test in MS patients will be examined. 3 m walk back test, Timed Up and Go, 4-Square Step Test test will be applied to the patients. All assessments will be done by the same physiotherapist. The second evaluation will be performed by the same physiotherapist two days after the first evaluation (test) to measure test-retest reliability. Data collection with the same rater will be preferred to avoid inter-rater variability and error rate between evaluations.

According to Lexell and Downham, 30-50 participants should be included in reliability studies [22]. Considering this recommendation, which defines the reliability of the L test, it is planned to include 50 individuals with MS in our study.

L Test; It is an expanded version of the TUG and is designed to assess advanced functional ambulation with more detail available elsewhere. It is recorded when the participant gets up from the chair, walks 3 m to a cone, turns 90° to the right, continues to walk 7 m to the next cone, turns 180° left around the cone, then returns to the chair the same way. The test duration is recorded, beginning with the word "go" and ending with the participant's back touching the back of the chair [23].

3-meter Walk Back Test; The 3-meter distance is marked with a black tape and participants are asked to align their heels with the black tape. Individuals are asked to walk backwards as soon as possible with the "walk" command and stop when they reach 3 meters. Meanwhile, the elapsed time is recorded in seconds. Evaluation will be done three times and the average time will be recorded [24].

Timed Get Up and Go Test; It is applied to assess the balance and fall risk of individuals. The patient is first asked to sit leaning on the chair. The patient is then asked to stand up, walk with regular steps for a predetermined distance of 3 meters, return at the end of 3 meters and sit in a chair. During the test, the patient's walking time is recorded in seconds with a stopwatch. The test was repeated three times and the mean value will be recorded [25].

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Caner F Demir, MD Professor
  • Phone Number: 2617 04242370000
  • Email: cfdemir@yahoo.com

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Individuals who applied to Fırat University Training and Research Hospital and were diagnosed with Relapsin-Remitting MS by a neurologist will be included in our study.

Description

Inclusion Criteria:

  • Inclusion criteria for volunteers; Individuals with relapsing-remitting type MS, who are between 18-65, EDSS scores between 1 ≤ and ≤ 5.5, individuals who score 24 and above in Mini Mental State Examination and who can walk a minimum of 20 m independently will be included.

Exclusion Criteria:

  • In addition, exclusion criteria for volunteers; Severe spasticity of the lower extremities (Ashworth score 3 or 4), having an acute MS attack or a history of an attack in the last 1 month, having an orthopedic or systemic problem that would prevent participation in the tests, having another neuromuscular disorder other than MS, visual involvement or diplopia, and is that he has a cardio-pulmonary problem that will prevent him from participating in the tests.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Multiple sclerosis
. Inclusion criteria for volunteers; Individuals with relapsing-remitting type MS, who are between 18-65, EDSS scores between 1 ≤ and ≤ 5.5, individuals who score 24 and above in Mini Mental State Examination and who can walk a minimum of 20 m independently will be included. In addition, exclusion criteria for volunteers; Severe spasticity of the lower extremities (Ashworth score 3 or 4), having an acute MS attack or a history of an attack in the last 1 month, having an orthopedic or systemic problem that would prevent participation in the tests, having another neuromuscular disorder other than MS, visual involvement or diplopia, and is that he has a cardio-pulmonary problem that will prevent him from participating in the tests.
Behavioral: L test
It is an expanded version of the TUG and is designed to assess advanced functional ambulation with more detail available elsewhere. It is recorded when the participant gets up from the chair, walks 3 m to a cone, turns 90° to the right, continues to walk 7 m to the next cone, turns 180° left around the cone, then returns to the chair the same way. The test time is recorded, starting with the word "go" and ending with the participant's back touching the back of the chair.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
L test
Time Frame: 1 week
It is an expanded version of the TUG and is designed to assess advanced functional ambulation with more detail available elsewhere. It is recorded when the participant gets up from the chair, walks 3 m to a cone, turns 90° to the right, continues to walk 7 m to the next cone, turns 180° left around the cone, then returns to the chair the same way. The test time is recorded, starting with the word "go" and ending with the participant's back touching the back of the chair.
1 week
Timed Get Up and Go Test
Time Frame: 1 week
It is applied to assess the balance and fall risk of individuals. The patient is first asked to sit leaning on the chair. The patient is then asked to stand up, walk with regular steps for a predetermined distance of 3 meters, return at the end of 3 meters and sit in a chair. During the test, the patient's walking time is recorded in seconds with a stopwatch. The test was repeated three times and the average value will be recorded
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-meter Walk Back Test
Time Frame: 1 week
The 3-meter distance is marked with a black tape and participants are asked to align their heels with the black tape. Individuals are asked to walk backwards as soon as possible with the "walk" command and stop when they reach 3 meters. Meanwhile, the elapsed time is recorded in seconds. Evaluation will be done three times and average time will be recorded
1 week
10-Meter Walk Test (10MeWT)
Time Frame: 1 week
The 10MeWT was measured concurrently in the 2MWT (10MeWT-2M) and 6MWT (10MeWT-6M) to obtain the walking speeds of the participants. One reason for the simultaneous measurements was that the test protocols and the environmental set-up of the 2MWT, 6MWT and 10MeWT were very similar. Combining these tests could reduce the number of repeated walking and the resulting fatigue for the participants, and thus maximized their compliance to the tests. The walking speeds achieved in the 2MWT (10MeWT-2M) and 6MWT (10MeWT-6M) were treated as distinctive outcomes and analyzed separately because we believed that the instructions given to the participants in the 2MWT and 6MWT were different, possibly resulting in differences in the timed walk tests.
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Firat University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2022

Primary Completion (Anticipated)

April 18, 2022

Study Completion (Anticipated)

May 9, 2022

Study Registration Dates

First Submitted

April 6, 2022

First Submitted That Met QC Criteria

April 6, 2022

First Posted (Actual)

April 13, 2022

Study Record Updates

Last Update Posted (Actual)

April 13, 2022

Last Update Submitted That Met QC Criteria

April 6, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fırat Univers

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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