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

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ClinicalTrials.gov Identifier: NCT05182398
Recruitment Status : Not yet recruiting
First Posted : January 10, 2022
Last Update Posted : April 19, 2022
Sponsor:
Information provided by (Responsible Party):
Zekiye İpek KATIRCI KIRMACI, Kahramanmaras Sutcu Imam University

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.


Condition or disease Intervention/treatment
Multiple Sclerosis 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Investigation of Validity and Reliability of the Modified Four Square Step Test in Multiple Sclerosis Patients
Estimated Study Start Date : May 15, 2022
Estimated Primary Completion Date : July 15, 2022
Estimated Study Completion Date : August 15, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Modified Four Square Step Test [ Time Frame: First day ]
    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

  2. Modified Four Square Step Test [ Time Frame: second day ]
    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


Secondary Outcome Measures :
  1. Berg Balance scale [ Time Frame: First day ]
    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.

  2. Dynamic Gait Index [ Time Frame: First day ]
    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.

  3. Activity-Specific Balance Confidence Scale [ Time Frame: First day ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Multiple Sclerosis Patients
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05182398


Contacts
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Contact: Zekiye İpek KATIRCI KIRMACI +90 544 261 82 85 ipekkatirci@hotmail.com

Sponsors and Collaborators
Kahramanmaras Sutcu Imam University
Investigators
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Principal Investigator: Zekiye İpek Katırcı Kırmacı Kahramanmaraş Sütçü İmam University
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Responsible Party: Zekiye İpek KATIRCI KIRMACI, Asst. Prof., Kahramanmaras Sutcu Imam University
ClinicalTrials.gov Identifier: NCT05182398    
Other Study ID Numbers: ipekkatircikirmaci
First Posted: January 10, 2022    Key Record Dates
Last Update Posted: April 19, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zekiye İpek KATIRCI KIRMACI, Kahramanmaras Sutcu Imam University:
Fall
Modified Four Square Step Test
Multiple sclerosis
Balance
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases