NCT05325359

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

February 7, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 13, 2022

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2022

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2022

Completed
Last Updated

April 13, 2022

Status Verified

April 1, 2022

Enrollment Period

2 months

First QC Date

April 6, 2022

Last Update Submit

April 6, 2022

Conditions

Keywords

Multiple SclerosisBalanceL testValidityGait

Outcome Measures

Primary Outcomes (2)

  • 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.

    1 week

  • 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 average value will be recorded

    1 week

Secondary Outcomes (2)

  • 3-meter Walk Back Test

    1 week

  • 10-Meter Walk Test (10MeWT)

    1 week

Study Arms (1)

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

Interventions

L testBEHAVIORAL

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.

Multiple sclerosis

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fırat university

Elâzığ, 23100, Turkey (Türkiye)

RECRUITING

Related Publications (25)

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    PMID: 16510748BACKGROUND
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    PMID: 10668778BACKGROUND
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    PMID: 8989958BACKGROUND
  • Daley ML, Swank RL. Quantitative posturography: use in multiple sclerosis. IEEE Trans Biomed Eng. 1981 Sep;28(9):668-71. doi: 10.1109/TBME.1981.324761. No abstract available.

    PMID: 7319527BACKGROUND
  • Lanzetta D, Cattaneo D, Pellegatta D, Cardini R. Trunk control in unstable sitting posture during functional activities in healthy subjects and patients with multiple sclerosis. Arch Phys Med Rehabil. 2004 Feb;85(2):279-83. doi: 10.1016/j.apmr.2003.05.004.

    PMID: 14966714BACKGROUND
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    PMID: 12048669BACKGROUND
  • Guideline for the prevention of falls in older persons. American Geriatrics Society, British Geriatrics Society, and American Academy of Orthopaedic Surgeons Panel on Falls Prevention. J Am Geriatr Soc. 2001 May;49(5):664-72. No abstract available.

    PMID: 11380764BACKGROUND
  • DeBolt LS, McCubbin JA. The effects of home-based resistance exercise on balance, power, and mobility in adults with multiple sclerosis. Arch Phys Med Rehabil. 2004 Feb;85(2):290-7. doi: 10.1016/j.apmr.2003.06.003.

    PMID: 14966716BACKGROUND
  • Cattaneo D, Cardini R. Computerized system to improve voluntary control of balance in neurological patients. Cyberpsychol Behav. 2001 Dec;4(6):687-94. doi: 10.1089/109493101753376632.

    PMID: 11800176BACKGROUND
  • Cattaneo D, Marazzini F, Crippa A, Cardini R. Do static or dynamic AFOs improve balance? Clin Rehabil. 2002 Dec;16(8):894-9. doi: 10.1191/0269215502cr547oa.

    PMID: 12501952BACKGROUND
  • Hobart JC, Riazi A, Lamping DL, Fitzpatrick R, Thompson AJ. Measuring the impact of MS on walking ability: the 12-Item MS Walking Scale (MSWS-12). Neurology. 2003 Jan 14;60(1):31-6. doi: 10.1212/wnl.60.1.31.

    PMID: 12525714BACKGROUND
  • Tesio L, Perucca L, Franchignoni FP, Battaglia MA. A short measure of balance in multiple sclerosis: validation through Rasch analysis. Funct Neurol. 1997 Sep-Oct;12(5):255-65.

    PMID: 9439943BACKGROUND
  • Smith PS, Hembree JA, Thompson ME. Berg Balance Scale and Functional Reach: determining the best clinical tool for individuals post acute stroke. Clin Rehabil. 2004 Nov;18(7):811-8. doi: 10.1191/0269215504cr817oa.

    PMID: 15573838BACKGROUND
  • Tsang CS, Liao LR, Chung RC, Pang MY. Psychometric properties of the Mini-Balance Evaluation Systems Test (Mini-BESTest) in community-dwelling individuals with chronic stroke. Phys Ther. 2013 Aug;93(8):1102-15. doi: 10.2522/ptj.20120454. Epub 2013 Apr 4.

    PMID: 23559522BACKGROUND
  • Breisinger TP, Skidmore ER, Niyonkuru C, Terhorst L, Campbell GB. The Stroke Assessment of Fall Risk (SAFR): predictive validity in inpatient stroke rehabilitation. Clin Rehabil. 2014 Dec;28(12):1218-24. doi: 10.1177/0269215514534276. Epub 2014 May 21.

    PMID: 24849795BACKGROUND
  • Sebastiao E, Sandroff BM, Learmonth YC, Motl RW. Validity of the Timed Up and Go Test as a Measure of Functional Mobility in Persons With Multiple Sclerosis. Arch Phys Med Rehabil. 2016 Jul;97(7):1072-7. doi: 10.1016/j.apmr.2015.12.031. Epub 2016 Mar 2.

    PMID: 26944709BACKGROUND
  • Nilsagard Y, Lundholm C, Gunnarsson LG, Dcnison E. Clinical relevance using timed walk tests and 'timed up and go' testing in persons with multiple sclerosis. Physiother Res Int. 2007 Jun;12(2):105-14. doi: 10.1002/pri.358.

    PMID: 17536648BACKGROUND
  • Nguyen VC, Miller WC, Asano M, Wong RY. Measurement properties of the L test for gait in hospitalized elderly. Am J Phys Med Rehabil. 2007 Jun;86(6):463-8. doi: 10.1097/PHM.0b013e31805b8193.

    PMID: 17515685BACKGROUND
  • 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
  • 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
  • Lexell JE, Downham DY. How to assess the reliability of measurements in rehabilitation. Am J Phys Med Rehabil. 2005 Sep;84(9):719-23. doi: 10.1097/01.phm.0000176452.17771.20.

    PMID: 16141752BACKGROUND
  • Haas B, Clarke E, Elver L, Gowman E, Mortimer E, Byrd E. The reliability and validity of the L-test in people with Parkinson's disease. Physiotherapy. 2019 Mar;105(1):84-89. doi: 10.1016/j.physio.2017.11.218. Epub 2017 Dec 5.

    PMID: 29395266BACKGROUND
  • Bilek F, Demir CF. Validity and reliability of the 3-meter backward walk test in mildly disabled persons with multiple sclerosis. Mult Scler Relat Disord. 2022 Feb;58:103532. doi: 10.1016/j.msard.2022.103532. Epub 2022 Jan 19.

    PMID: 35066275BACKGROUND
  • Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.

    PMID: 1991946BACKGROUND
  • Roos MA, Reisman DS, Hicks G, Rose W, Rudolph KS. Development of the Modified Four Square Step Test and its reliability and validity in people with stroke. J Rehabil Res Dev. 2016;53(3):403-12. doi: 10.1682/JRRD.2014.04.0112.

    PMID: 27271003BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Furkan Bilek, Lecturer

CONTACT

Caner F Demir, MD Professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

April 6, 2022

First Posted

April 13, 2022

Study Start

February 7, 2022

Primary Completion

April 18, 2022

Study Completion

May 9, 2022

Last Updated

April 13, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations