NCT04753411

Brief Summary

The 3-m backward walk test (3MBWT) is used to evaluate neuromuscular control, proprioception, protective reflexes, fall risk and balance. The aim of our study was to reveal the test-retest reliability and validity of the 3MBWT in Multiple Sclerosis patients. Our study will be done as a "test-retest" design and psychometric properties of 3 m backward walking test in MS patients will be examined. Mini Mental State Examination, 3 m walk back test, Berg Balance Scale, Timed Up and Go, Timed 25 Step Walking Test and 4-Square Step Test will be applied to the patients. All evaluations will be made by the same physiotherapist. The second and third evaluation (retest) will be performed by the same physiotherapist two days after the first evaluation (test) and 2 weeks later to measure test-retest reliability. It will be preferable to collect data with the same evaluator to avoid inter-rater error rate between evaluations. It will be preferable to collect data with the same evaluator to avoid inter-rater error rate between evaluations. The sample size, according to Lexell and Downham (2005), 40-50 participants should be included in reliability studies. Considering this recommendation, which defines the reliability of 3MBWT, it is planned to include 50 individuals with MS in our study.

Trial Health

35
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 2021

Shorter than P25 for all trials

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 5, 2021

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 15, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2021

Completed
Last Updated

February 15, 2021

Status Verified

February 1, 2021

Enrollment Period

2 months

First QC Date

February 10, 2021

Last Update Submit

February 10, 2021

Conditions

Keywords

Multiple SclerosisBalanceBackward

Outcome Measures

Primary Outcomes (4)

  • 3 Meter Backward Walking Test

    The 3-meter distance is marked with a black tape and the participants are asked to align their heels with 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. The evaluation will take place three times and the average time will be recorded.

    2 weeks

  • Berg Balance Scale

    It was designed for quantitative evaluation of balance and determination of fall risk, and was chosen because it evaluates individuals' ability to maintain their balance while performing functional activities. According to the scores obtained from the test in question, the cases were divided into groups as "high fall risk (0-20 points)", "medium fall risk (21-40 points)", "low fall risk (41-56)". score) ". Fifty-six, the highest score, is considered to show the best balance. Turkish validity and reliability study of the scale was conducted by Şahin et al.

    1 day

  • 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 on a chair. The patient is then asked to stand up, walk regularly at a predetermined distance of 3 meters, return at the end of 3 meters and sit on a chair. The walking time of the patient during the test is recorded with the stopwatch in seconds. The test was repeated three times and the average value will be recorded

    1 day

  • 4-Square Step Test

    Aims to evaluate dynamic balance and stepping forward, side and back over objects. Using tape, 1 horizontal and 1 vertical line is made in the form of diagonal 4 divisions. At the start of the test, the individual stands in the upper left square. Then they step clockwise with both feet before moving on to the next frame: first to the right, then back, then to the left, and finally to the back position. They immediately follow this by stepping counterclockwise. After 1 application attempt, the time is saved for the next 2 attempts and the best 1 attempt is counted. Among older adults living in the community, over 15 seconds has been associated with an increased risk of falling

    1 day

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 diagnosed with MS by a neurologist will be included.

You may qualify if:

  • Individuals with relapsing-remitting MS, with an EDSS score between 05≤ and ≤5.5, with an EDSS score between 18-65, and individuals with a score of 24 and above in the Mini Mental State Examination and who can independently walk a minimum of 10 m will be included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (18)

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    PMID: 16510748BACKGROUND
  • Pelfrey CM, Cotleur AC, Lee JC, Rudick RA. Sex differences in cytokine responses to myelin peptides in multiple sclerosis. J Neuroimmunol. 2002 Sep;130(1-2):211-23. doi: 10.1016/s0165-5728(02)00224-2.

    PMID: 12225904BACKGROUND
  • Frzovic D, Morris ME, Vowels L. Clinical tests of standing balance: performance of persons with multiple sclerosis. Arch Phys Med Rehabil. 2000 Feb;81(2):215-21. doi: 10.1016/s0003-9993(00)90144-8.

    PMID: 10668778BACKGROUND
  • Williams NP, Roland PS, Yellin W. Vestibular evaluation in patients with early multiple sclerosis. Am J Otol. 1997 Jan;18(1):93-100.

    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
  • Cattaneo D, De Nuzzo C, Fascia T, Macalli M, Pisoni I, Cardini R. Risks of falls in subjects with multiple sclerosis. Arch Phys Med Rehabil. 2002 Jun;83(6):864-7. doi: 10.1053/apmr.2002.32825.

    PMID: 12048669BACKGROUND
  • 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
  • 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
  • Thomas MA, Fast A. One step forward and two steps back: the dangers of walking backwards in therapy. Am J Phys Med Rehabil. 2000 Sep-Oct;79(5):459-61. doi: 10.1097/00002060-200009000-00011.

    PMID: 10994888BACKGROUND
  • Carter V, Jain T, James J, Cornwall M, Aldrich A, de Heer HD. The 3-m Backwards Walk and Retrospective Falls: Diagnostic Accuracy of a Novel Clinical Measure. J Geriatr Phys Ther. 2019 Oct/Dec;42(4):249-255. doi: 10.1519/JPT.0000000000000149.

    PMID: 29095771BACKGROUND
  • Rose DK, DeMark L, Fox EJ, Clark DJ, Wludyka P. A Backward Walking Training Program to Improve Balance and Mobility in Acute Stroke: A Pilot Randomized Controlled Trial. J Neurol Phys Ther. 2018 Jan;42(1):12-21. doi: 10.1097/NPT.0000000000000210.

    PMID: 29232308BACKGROUND
  • Abit Kocaman A, Aydogan Arslan S, Ugurlu K, Katirci Kirmaci ZI, Keskin ED. Validity and Reliability of The 3-Meter Backward Walk Test in Individuals with Stroke. J Stroke Cerebrovasc Dis. 2021 Jan;30(1):105462. doi: 10.1016/j.jstrokecerebrovasdis.2020.105462. Epub 2020 Nov 13.

    PMID: 33197801BACKGROUND
  • 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
  • Sahin F, Yilmaz F, Ozmaden A, Kotevolu N, Sahin T, Kuran B. Reliability and validity of the Turkish version of the Berg Balance Scale. J Geriatr Phys Ther. 2008;31(1):32-7. doi: 10.1519/00139143-200831010-00006.

    PMID: 18489806BACKGROUND
  • 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

Study Design

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

Study Record Dates

First Submitted

February 10, 2021

First Posted

February 15, 2021

Study Start

February 5, 2021

Primary Completion

April 4, 2021

Study Completion

May 4, 2021

Last Updated

February 15, 2021

Record last verified: 2021-02