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Efficacy of Square- Stepping Exercises in Individuals With Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Square Step Exercises Program
Home Exercise Program
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Mobility, Balance, Position Sense

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Having a disability score of less than 4 Being between 20-50 years old Not having an attack in the last month Patients without lower extremity spasticity according to Modified Ashworth Scale (MAS) Exclusion Criteria: Having a neurological disease other than Multiple Sclerosis Having an Multiple Sclerosis attack during the study Having had orthopedic surgery affecting balance Presence of cognitive and psychiatric influences that will affect participation in the study Having a cardiovascular or pulmonary history that would inhibit participation in the study Have received steroid and/or immunosuppressive therapy in the past four weeks

Sites / Locations

  • Pamukkale University Denizli Health Services Vocational School of Higher EducationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Square-Stepping Exercise Program Group

Home Exercise Program Group

Arm Description

Square stepping exercise is performed on a thin exercise mat divided into 40 small squares of 250 cm x 100 cm. Participants practice a set of step patterns on the mat. Square step exercises are a low-cost, highly accessible and fun exercise method. It is known that it improves motor performance and muscle strength in healthy young individuals, and has positive effects on functional fitness and gait parameters in individuals with osteoarthritis. It is known to have positive effects on balance, fall risk, walking ability, physical and cognitive function in elderly individuals. It will be applied to examine the effects on mobility, balance and position sense in individuals with multiple sclerosis.

The home exercise program group will implement a protocol of frenkel's coordination exercises developed for balance and coordination therapy. The exercise protocol, which includes frenkel's coordination exercises, will be delivered to the patient in the form of a brochure and in the form of a Compact Disc (CD) with video images.

Outcomes

Primary Outcome Measures

Timed 25-Foot Walk (T25-FW) Test
With the Timed 25-Foot Walk (T25-FW) Test, the patient's walking speed and lower extremity functions are evaluated. The patient is asked to walk a distance of 7.62 m (25 feet) safely and as quickly as possible. The passing time is recorded in seconds with the chronometer. The T25-FW is the best-defined measurement method for the measurement of gait disturbance in patients with MS and the evaluation of gait speeds of patients with many gait disorders in the clinical setting.

Secondary Outcome Measures

Five Times Sit to Stand Test
The patient is asked to sit down and stand up from a standard chair as fast as possible with 5 repetitions. The test starts from a sitting position and ends in a sitting position. The result is recorded in seconds. This method, which is valid and reliable in MS, has been shown to be associated with lower extremity muscle strength and balance. Low times are indicative of high performance.
Four Step Square Test (FSST)
It is a test method used to evaluate the dynamic balance status of individuals. Four squares are formed by placing two canes on a flat surface. All squares are numbered. At the beginning of the test, the patient is told to step into each square as fast as possible, without touching the canes, in consecutive order (2-3-4-1-4-3-2-1). (Requires the patient to step forward, backward, to the right and left side). The time to complete the test is recorded as a score. Low times are indicative of high performance.
Activity-Specific Balance Confidence Scale
It measures the effect of balance disorder on the psychology of the patient. It is a self-report scale in which patients evaluate how confidently they can perform 16 activities that require balance skills, both inside and outside the home, between 0% (unsafe) and 100% (with complete confidence).
Knee Joint Position Sense
The knee joint position sense will be evaluated with the KFORCE Sens® electrogoniometer. For standardization of sensory measurements, the patient is evaluated in a sitting position with the back supported and the hips and knees flexed to 90°. The knee extension angles of 30 and 60 degrees according to the initial position are determined as the target angle, and the repositioning error of the participant is checked. When the participant brings the knee joint to the target angle, the participant is asked to learn the angle by waiting five seconds at this point. Then the knee is brought to the neutral position and the patient is asked to find the target angle. For the target angles, the measurements are repeated three times, the average value is calculated and the reposition error degree of the patients is recorded.
Expanded Disability Status Scale (EDSS)
The EDSS scale is a scale that provides information about the disability status of the patient. Functional systems evaluated by EDSS are pyramidal, cerebral, cerebellar, visual, sensory, brain stem, bladder and bowel functions. Scoring is done between 0 and 10. Scoring between 0 and 3.5 indicates mild disability, scoring between 4.0 and 6.5 indicates moderate disability, and scoring between 7.0 and 10.0 indicates severe disability.

Full Information

First Posted
December 24, 2022
Last Updated
April 10, 2023
Sponsor
Pamukkale University
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1. Study Identification

Unique Protocol Identification Number
NCT05682963
Brief Title
Efficacy of Square- Stepping Exercises in Individuals With Multiple Sclerosis
Official Title
Effect of Square- Stepping Exercises on Mobility, Balance and Knee Joint Position Sense in Individuals With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2023 (Actual)
Primary Completion Date
December 30, 2025 (Anticipated)
Study Completion Date
January 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Square stepping exercises can promote correct foot placement, fast and coordinated step patterns, and sensory-motor interaction. The aim of this study is to examine the effect of square stepping exercises on mobility, balance and knee joint position sense in individuals with multiple sclerosis.
Detailed Description
Multiple sclerosis (MS) is a chronic, inflammatory, autoimmune disease of the central nervous system that results in neurological disability. Complex gene-environment interactions play a role in the etiology of multiple sclerosis. Multiple sclerosis is more common in women than men, with a ratio ranging from 2:1 to 3:1. MS is a very heterogeneous disease and it can have very variable clinical signs and symptoms, including motor, sensory, autonomic and cognitive disorders, depending on the region of the central nervous system. Balance and mobility disorders are the leading symptoms of MS. In addition, somatosensory disorders are frequently encountered as the initial symptom. Disorders in position sense, which is one of the components of somatosensory sense, is an important determinant of limitations during dynamic activities such as walking and balance. In order to reduce disability and improve function in individuals with Multiple Sclerosis, square stepping exercises protocol will be given to one group and a home exercise program protocol to the other group. Created by Shigematsu and Okura to improve balance and reduce the risk of falling, the square stepping exercises is performed on a thin exercise mat divided into 40 small squares of 250 cm x 100 cm. There are a number of step patterns that must be followed by the participants. Certain step patterns will be repeated 3-5 times to the participants and the participant will be asked to repeat the same pattern. As a home exercise protocol, a program consisting of frenkel exercises developed by Professor Heinrich Sebastian Frenkel for the treatment of gait, balance and coordination will be applied. Square stepping exercises can promote correct foot placement, fast and coordinated step patterns, and sensory-motor interaction. The aim of this study is to examine the effect of square stepping exercises on mobility, balance and knee joint position sense in individuals with multiple sclerosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, Mobility, Balance, Position Sense

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Total of two groups: Square stepping exercise program group and home exercise program group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Square-Stepping Exercise Program Group
Arm Type
Active Comparator
Arm Description
Square stepping exercise is performed on a thin exercise mat divided into 40 small squares of 250 cm x 100 cm. Participants practice a set of step patterns on the mat. Square step exercises are a low-cost, highly accessible and fun exercise method. It is known that it improves motor performance and muscle strength in healthy young individuals, and has positive effects on functional fitness and gait parameters in individuals with osteoarthritis. It is known to have positive effects on balance, fall risk, walking ability, physical and cognitive function in elderly individuals. It will be applied to examine the effects on mobility, balance and position sense in individuals with multiple sclerosis.
Arm Title
Home Exercise Program Group
Arm Type
Active Comparator
Arm Description
The home exercise program group will implement a protocol of frenkel's coordination exercises developed for balance and coordination therapy. The exercise protocol, which includes frenkel's coordination exercises, will be delivered to the patient in the form of a brochure and in the form of a Compact Disc (CD) with video images.
Intervention Type
Other
Intervention Name(s)
Square Step Exercises Program
Intervention Description
Intervention description: patient will be treated for eight weeks, two days a week, one session a day, and total 16 session. Each session will be 45 minute.
Intervention Type
Other
Intervention Name(s)
Home Exercise Program
Intervention Description
Frenkel's coordination exercises will be applied as a home program for 8 weeks, 2 days a week, with each exercise session 15-30 minutes excluding rest periods.
Primary Outcome Measure Information:
Title
Timed 25-Foot Walk (T25-FW) Test
Description
With the Timed 25-Foot Walk (T25-FW) Test, the patient's walking speed and lower extremity functions are evaluated. The patient is asked to walk a distance of 7.62 m (25 feet) safely and as quickly as possible. The passing time is recorded in seconds with the chronometer. The T25-FW is the best-defined measurement method for the measurement of gait disturbance in patients with MS and the evaluation of gait speeds of patients with many gait disorders in the clinical setting.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Five Times Sit to Stand Test
Description
The patient is asked to sit down and stand up from a standard chair as fast as possible with 5 repetitions. The test starts from a sitting position and ends in a sitting position. The result is recorded in seconds. This method, which is valid and reliable in MS, has been shown to be associated with lower extremity muscle strength and balance. Low times are indicative of high performance.
Time Frame
8 week
Title
Four Step Square Test (FSST)
Description
It is a test method used to evaluate the dynamic balance status of individuals. Four squares are formed by placing two canes on a flat surface. All squares are numbered. At the beginning of the test, the patient is told to step into each square as fast as possible, without touching the canes, in consecutive order (2-3-4-1-4-3-2-1). (Requires the patient to step forward, backward, to the right and left side). The time to complete the test is recorded as a score. Low times are indicative of high performance.
Time Frame
8 week
Title
Activity-Specific Balance Confidence Scale
Description
It measures the effect of balance disorder on the psychology of the patient. It is a self-report scale in which patients evaluate how confidently they can perform 16 activities that require balance skills, both inside and outside the home, between 0% (unsafe) and 100% (with complete confidence).
Time Frame
8 week
Title
Knee Joint Position Sense
Description
The knee joint position sense will be evaluated with the KFORCE Sens® electrogoniometer. For standardization of sensory measurements, the patient is evaluated in a sitting position with the back supported and the hips and knees flexed to 90°. The knee extension angles of 30 and 60 degrees according to the initial position are determined as the target angle, and the repositioning error of the participant is checked. When the participant brings the knee joint to the target angle, the participant is asked to learn the angle by waiting five seconds at this point. Then the knee is brought to the neutral position and the patient is asked to find the target angle. For the target angles, the measurements are repeated three times, the average value is calculated and the reposition error degree of the patients is recorded.
Time Frame
8 week
Title
Expanded Disability Status Scale (EDSS)
Description
The EDSS scale is a scale that provides information about the disability status of the patient. Functional systems evaluated by EDSS are pyramidal, cerebral, cerebellar, visual, sensory, brain stem, bladder and bowel functions. Scoring is done between 0 and 10. Scoring between 0 and 3.5 indicates mild disability, scoring between 4.0 and 6.5 indicates moderate disability, and scoring between 7.0 and 10.0 indicates severe disability.
Time Frame
8 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Having a disability score of less than 4 Being between 20-50 years old Not having an attack in the last month Patients without lower extremity spasticity according to Modified Ashworth Scale (MAS) Exclusion Criteria: Having a neurological disease other than Multiple Sclerosis Having an Multiple Sclerosis attack during the study Having had orthopedic surgery affecting balance Presence of cognitive and psychiatric influences that will affect participation in the study Having a cardiovascular or pulmonary history that would inhibit participation in the study Have received steroid and/or immunosuppressive therapy in the past four weeks
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Müge İçelli, M.Sc.
Phone
+905077325823
Email
micelli@pau.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Tuba Can Akman, Assoc. Prof
Email
tubacan@pau.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Müge İçelli, M.Sc.
Organizational Affiliation
Pamukkale University Denizli Health Services Vocational School of Higher Education
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pamukkale University Denizli Health Services Vocational School of Higher Education
City
Denizli
State/Province
Centre
ZIP/Postal Code
20160
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
müge içelli, M.Sc.
Phone
+905077325823
Email
micelli@pau.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of Square- Stepping Exercises in Individuals With Multiple Sclerosis

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