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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Assesment

Detailed 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 Four Square Step Test is a standard clinical measure used to assess dynamic standing balance.The individual rapidly forwards over a low obstacle (a cane), is a timed test in which instructed to step backward and to the right and left.The four-frame stepping test was developed to document deficiencies in stance balance, predict falls, assess self-perceived limitations in walking, and compare changes in standing balance following exercise training. 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. 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.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Zekiye İpek KATIRCI KIRMACI; Phone Number: +90 544 261 82 85; Email: ipekkatirci@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Multiple Sclerosis Patients

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Modified Four Square Step Test, Berg Balance Scale, Dynamic Gait Index ,Activity-Specific Balance Confidence Scale

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Dynamic Gait Index	It consists of 8 walking activities: normal walking, fast-slow walking, walking with horizontal and vertical head movements, walking by jumping from the disabled floor and walking around the obstacle, and turning 360 degrees abruptly on command, going up and down the stairs. During these 8 activities, the patient's performance is scored between 0-3 (0=severe, 3=normal) and the total score is recorded.	First day
Activity-Specific Balance Confidence Scale	It is a scale that evaluates how confidently people can do 16 activities outside and inside the home. Activities are scored between 0 (unsafe) and 100 (completely confident). A score is obtained by dividing the total score by 16. A higher score indicates greater confidence.	First day

Collaborators and Investigators

• Sponsor: Kahramanmaras Sutcu Imam University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 15, 2022
• Primary Completion (Anticipated): July 15, 2022
• Study Completion (Anticipated): August 15, 2022

Study Registration Dates

• First Submitted: December 15, 2021
• First Submitted That Met QC Criteria: January 6, 2022
• First Posted (Actual): January 10, 2022

Study Record Updates

• Last Update Posted (Actual): April 19, 2022
• Last Update Submitted That Met QC Criteria: April 18, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Balance; Multiple sclerosis; Fall; Modified Four Square Step Test
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: ipekkatircikirmaci

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No