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NCT Number: NCT05682963

Efficacy of Square- Stepping Exercises in Individuals With Multiple Sclerosis

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pamukkale University Denizli Health Services Vocational School of Higher Education

Denizli, Centre, 20160, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Square Step Exercises Program

Other

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.

Home exercise program

Other

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 outcomes

  1. Timed 25-Foot Walk (T25-FW) Test

    Time frame: 8 weeks

    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 outcomes

  1. Five Times Sit to Stand Test

    Time frame: 8 week

    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.

  2. Four Step Square Test (FSST)

    Time frame: 8 week

    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.

  3. Activity-Specific Balance Confidence Scale

    Time frame: 8 week

    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).

  4. Knee Joint Position Sense

    Time frame: 8 week

    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.

  5. Expanded Disability Status Scale (EDSS)

    Time frame: 8 week

    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.

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

Effect of Square- Stepping Exercises on Mobility, Balance and Knee Joint Position Sense in Individuals With Multiple Sclerosis

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 12, 2023
Registry last updated
Jan 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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