CClinicalTrials.gg
CompletedNCT05682963Updated Jan 8, 2024

Efficacy of Square- Stepping Exercises in Individuals With Multiple Sclerosis

An interventional study of Square Step Exercises Program and Home Exercise Program in Multiple Sclerosis, sponsored by Pamukkale University. Completed at 1 site in Turkey. Open to participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-01-08.

Sponsored by Pamukkale University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Multiple Sclerosis

Keywords

  • Multiple Sclerosis
  • Mobility
  • Balance
  • Position Sense
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 34 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Pamukkale University is the lead sponsor of 331 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • Active comparator
    Square-Stepping Exercise Program Group

    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.

    Other: Square Step Exercises Program

  • Active comparator
    Home Exercise Program Group

    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.

    Other: Home Exercise Program

Interventions

  • OtherSquare Step Exercises Program

    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.

  • OtherHome Exercise Program

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 8 weeks

Secondary outcomes

  1. 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.

    Time frame: 8 week

  2. 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.

    Time frame: 8 week

  3. 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).

    Time frame: 8 week

  4. 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.

    Time frame: 8 week

  5. 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.

    Time frame: 8 week

07

Study locations

1 site
  • Pamukkale University Denizli Health Services Vocational School of Higher Education
    Denizli, Centre 20160, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05682963
Lead sponsor
Pamukkale University
Responsible party
müge içelli (lecturer, Pamukkale University) — Principal investigator
First posted
Jan 12, 2023
Start date
Nov 29, 2022
Primary completion
Jun 30, 2023
Completion
Dec 25, 2023
Last update
Jan 8, 2024

Study contacts

Müge İçelli, M.Sc.
principal investigator · Pamukkale University Denizli Health Services Vocational School of Higher Education

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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