Efficacy of Square- Stepping Exercises in Individuals With Multiple Sclerosis

NCT05682963 | Completed

• 1 other identifier: PU-FTR-MI-01
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Mobility; Balance; Position Sense

Outcome Measures

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.

  8 weeks

Secondary Outcomes (5)

• Five Times Sit to Stand Test

  8 week

• Four Step Square Test (FSST)

  8 week

• Activity-Specific Balance Confidence Scale

  8 week

• Knee Joint Position Sense

  8 week

• Expanded Disability Status Scale (EDSS)

  8 week

Study Arms (2)

Square-Stepping Exercise Program Group

ACTIVE COMPARATOR

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

Home Exercise Program Group

ACTIVE COMPARATOR

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

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.

Square-Stepping Exercise Program Group

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.

Home Exercise Program Group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University Denizli Health Services Vocational School of Higher Education

Denizli, Centre, 20160, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Müge İçelli, M.Sc.

  Pamukkale University Denizli Health Services Vocational School of Higher Education

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: Total of two groups: Square stepping exercise program group and home exercise program group

Study Record Dates

• First Submitted: December 24, 2022
• First Posted: January 12, 2023
• Study Start: November 29, 2022
• Primary Completion: June 30, 2023
• Study Completion: December 25, 2023
• Last Updated: January 8, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)