Clinical trial NCT05182398: Validity and Reliability of the Modified Four Square Step Test in Multiple Sclerosis Patients
Official title: Investigation of Validity and Reliability of the Modified Four Square Step Test in Multiple Sclerosis Patients
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Multiple Sclerosis
Keywords: Fall
Modified Four Square Step Test
Multiple sclerosis
Balance
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2022-01-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Multiple Sclerosis Patients

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Modified Four Square Step Test
timeFrame: First day
measure: Modified Four Square Step Test
timeFrame: second day
Secondary outcomes:
measure: Berg Balance scale
timeFrame: First day
measure: Dynamic Gait Index
timeFrame: First day
measure: Activity-Specific Balance Confidence Scale
timeFrame: First day
Other outcomes:
Locations:
Study officials:
affiliation: Kahramanmaras Sutcu Imam University
name: Zekiye İpek Katırcı Kırmacı
role: PRINCIPAL_INVESTIGATOR
References: