Viewing Study NCT04753411



Ignite Creation Date: 2024-05-06 @ 3:46 PM
Last Modification Date: 2024-10-26 @ 1:56 PM
Study NCT ID: NCT04753411
Status: UNKNOWN
Last Update Posted: 2021-02-15
First Post: 2021-02-10

Brief Title: The 3-Meter Backward Walk Test in Individuals With Multiple Sclerosis
Sponsor: Firat University
Organization: Firat University

Study Overview

Official Title: Validity and Reliability of The 3-Meter Backward Walk Test in Individuals With Multiple Sclerosis
Status: UNKNOWN
Status Verified Date: 2021-02
Last Known Status: NOT_YET_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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
Detailed Description: The methodological model of the study is the validity and reliability study Individuals who applied to Fırat University Training and Research Hospital after ethical approval and diagnosed with MS by a neurologist will be included in our study It is planned to collect data from individuals who meet the inclusion criteria on a voluntary basis with the Helsinki Declaration As demographic characteristics Patients age gender body weight height EDSS score occupation and education status as a history of the disease the number of falls in the last year and the type of MS will be recorded Inclusion criteria for the volunteers Individuals with relapsing-remitting MS with an EDSS score between 05 and 55 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 Also exclusion criteria for volunteers High level spasticity of the lower limbs Ashworth score 3 or 4 who had an acute MS attack or had a history of an attack within the last 1 month had orthopedic or systemic problems that prevented participation in tests had another known neuromuscular disorder other than MS had visual involvement or diplopia and Having a cardio-pulmonary problem that will prevent him from participating in tests

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

The sample size according to Lexell and Downham 30-50 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

Statistical analysis SPSS for Windows 2000 computer package program will be used for all statistical analyzes Descriptive statistical information will be given as mean standard deviation x SD or Interclass Correlation Coefficients ICC and Cronbachs coefficients values will be examined for the reliability and internal consistency of 3MGDYT The data will be analyzed with appropriate statistical methods and the statistical significance level will be accepted as p 005

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None