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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05433714
Other study ID # ipekkrmc
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2022
Est. completion date October 6, 2022

Study information

Verified date October 2022
Source Kahramanmaras Sutcu Imam University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Balance disorder is common in people with MS. As the disease worsens, it is associated with impaired balance, difficulty walking, decreased mobility, and an increased risk of falling. Given the prevalence and clinical significance of balance dysfunction in individuals with MS, the assessment of balance has become an important focus in MS clinical practice and research. The figure of 8 Walk Test is a standard clinical measure used to evaluate the forward walking performance required in daily life. Beyond walking straight, turning ability is required in many situations in daily life such as walking around a table, avoiding obstacles and navigating the street. The gait characteristics of walking on a straight and curved road are different. During curved walking, the center of mass of the body shifts to the inner leg as the stance time of the inner leg increases, as opposed to walking on a straight track. Compared to other standardized tests, scoring is not dependent on the subjectivity of the examiner, can be administered by a person with minimal training, and requires minimal time, space, and equipment. The test assesses the ability to quickly change direction of movement and is a timed test involving the use of assistive devices.


Description:

Multiple sclerosis (MS) is a progressive disease of the central nervous system characterized by demyelination and destruction of motor and sensory axons. As the disease worsens, it is associated with impaired balance, difficulty walking, decreased mobility, and an increased risk of falling. The prevalence of balance dysfunction in individuals with MS and Given its clinical relevance, the assessment of balance has become an important focus in MS clinical practice and research. The figure of 8 Walk Test is a standard clinical measure used to evaluate the forward walking performance required in daily life.In the figure of 8 walk test, two cones are placed 1.5 meters apart. The individual stands in the middle of this distance. At the start of the test, he goes around the first cone as fast as he can walk around the first cone, then when he comes to the other starting point, this time around the other cone. The elapsed time is recorded. The aim of the study is to examine the validity and reliability of the 8-shape walking test in MS patients.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date October 6, 2022
Est. primary completion date October 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Having an EDSS score of 4 and below, - Being between the ages of 18-65 - Willingness to participate in the study Exclusion Criteria: - Being pregnant or within the first 3 months after giving birth, - Receiving corticosteroid therapy in the last 1 month, - Using drugs that will affect walking in the last 1 month

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Assesment
The figure of walk test, Berg Balance scale, Timed 25-Foot Walk, Timed up and go test, Foursquare walk test

Locations

Country Name City State
Turkey Kahramanmaras Sutcu Imam University Kahramanmaras

Sponsors (1)

Lead Sponsor Collaborator
Kahramanmaras Sutcu Imam University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Figure of Walk Test Two cones are placed 1.5 meters apart. The individual stands in the middle of this distance. At the start of the test, he goes around the first cone as fast as he can walk around the first cone, then when he comes to the other starting point, this time around the other cone. Elapsed time is recorded First day
Primary The Figure of Walk Test Two cones are placed 1.5 meters apart. The individual stands in the middle of this distance. At the start of the test, he goes around the first cone as fast as he can walk around the first cone, then when he comes to the other starting point, this time around the other cone. Elapsed time is recorded second day
Secondary Berg Balance scale It is a 14-item scale that measures the ability to maintain balance while performing functional tasks. Each item is scored between 0 and 4. Balance is considered good if the total score is 45 and above. First day
Secondary Timed up and go test At the beginning of the test, individuals sit in a chair. A distance of 3 m is set in front of it. With the start command, he gets up from his seat and walks 3 m, turns around and walks back and sits. With the start command, the time to sit on the chair is recorded in seconds. Short duration indicates good functional mobility. First day
Secondary Timed 25-Foot Walk test It is an evaluation to evaluate mobility and leg functions. Individuals are asked to safely walk 7.62 m on a flat surface at their highest speed. First day
Secondary Four Square Step Test It aims to assess dynamic balance and step objects forward, sideways and backwards. The square drawn on the floor is divided into 4 equal parts. The number 1 is written in the lower right corner, up to 4 clockwise. With the start command, individuals are asked to step on the numbers in order. First day
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