Validity and Reliability of the Modified Four Square Step Test in Multiple Sclerosis Patients

NCT05182398 | Withdrawn

• 1 other identifier: ipekkatircikirmaci
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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 Four Square Step Test is a standard clinical measure used to assess dynamic standing balance. It is a timed test in which the individual is instructed to step rapidly forward, backward, and to the right and left over a low obstacle (a cane). The test assesses the ability to quickly change direction of movement and is a timed test involving the use of assistive devices. In the modified four-square stepping test, the floor is divided into four equal squares with tape instead of a cane. Performing the test with tape, instead of patients at risk of being stuck with a cane, will ensure its applicability to a wider patient population. The aim of the study is to examine the validity and reliability of the modified four-frame stepping test in MS patients.

Conditions

Multiple Sclerosis

Keywords

Fall; Modified Four Square Step Test; Multiple sclerosis; Balance

Outcome Measures

Primary Outcomes (2)

• Modified Four Square Step Test

  The square drawn on the floor is divided by tape into 4 equal parts. The number 1 is written in the lower right corner, and the number 4 is written clockwise. With the start command, individuals are asked to step on the numbers in order. First of all, he is asked to take a step forward (to the number 1 and 2), then to the left (to the number 3), then to the back (to the number 4). Then he is asked to take steps from 4 to 1 again. Time is saved

  First day

• Modified Four Square Step Test

  The square drawn on the floor is divided by tape into 4 equal parts. The number 1 is written in the lower right corner, and the number 4 is written clockwise. With the start command, individuals are asked to step on the numbers in order. First of all, he is asked to take a step forward (to the number 1 and 2), then to the left (to the number 3), then to the back (to the number 4). Then he is asked to take steps from 4 to 1 again. Time is saved

  second day

Secondary Outcomes (3)

• Berg Balance scale

  First day

• Dynamic Gait Index

  First day

• Activity-Specific Balance Confidence Scale

  First day

Study Arms (1)

Multiple sclerosis patient

First day, first evaluator will perform all tests, and second day, second evaluator will perform Modified Four Square Step Test.

Other: Assesment

Interventions

Assesment OTHER

Modified Four Square Step Test, Berg Balance Scale, Dynamic Gait Index ,Activity-Specific Balance Confidence Scale

Multiple sclerosis patient

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Multiple Sclerosis Patients

You may qualify if:

• Having an EDSS score of 4 and below,
• Being between the ages of 18-65
• Willingness to participate in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Zekiye İpek Katırcı Kırmacı

  Kahramanmaras Sutcu Imam University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 10, 2022
• Study Start: May 15, 2022
• Primary Completion: July 15, 2022
• Study Completion: August 15, 2022
• Last Updated: March 10, 2025

Record last verified: 2025-03