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NCT Number: NCT04252053

The Effects of Pilates-Based Core Stabilization Training in Multiple Sclerosis

Multiple Sclerosis (MS) is a chronic, autoimmune and neurodegenerative disease characterized by inflammation and progressive demyelination of the central nervous system. It is characterized by muscle weakness, balance and coordination disorder, which is more common in the lower extremities and trunk muscles. Over time, these symptoms decrease the individual's level of physical activity, mobility and quality of life, leading to further deterioration of the disorder. One of the most important problems that cause these problems in individuals with MS is reduced core stabilization. Decrease in core stabilization affects the quality of limb movements as well as trunk stability when considering the kinetic chain in the body. Pilates-based core stabilization training (PBCST) are a controlled exercise form used to improve the stabilization of trunk muscles. There are no studies on the effect of this training on lower extremity isokinetic muscle strength in individuals with MS. The aim of this study is to determine the effect of PBCST on lower extremity muscle strength, postural sway and kinetic chain in individuals with MS.

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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–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University-Cerrahpasa

Istanbul, 34147, Turkey (Türkiye)

About this study

The study was planned as randomized controlled. Individuals included in the study wiil randomly allocate to the group receiving the supervised PBCST and the home exercise group. While the supervised exercise group receives PBCST for 2 days and 8 weeks in the clinic, the home exercise group will perform the same exercises at home for the same time as the brochures prepared for them. The exercise program will show progression at 2-week intervals. A session will be held for both groups to teach the basic principles of pilates and will not be counted in the 8-week program. At the beginning and end of treatment, individuals will be evaluated for isokinetic muscle strength, balance and postural sway, fatigue level, quality of life and functional capacity parameters. PBCST is thought to reduce postural sways and increase lower extremity muscle strength by increasing core stability with the effect of kinetic chain and increased stabilization.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Being diagnosed with MS according to McDonald's criteria
  • Disability level less than 6 according to EDSS (Expanded Disability Status Scale) score
  • No attacks during the last 3 months
  • Being an ambulatory
  • Volunteering to participate in the study

Exclusion criteria

  • Having orthopedic, neurological, psychological, etc. diseases that accompany MS and may affect treatment outcomes
  • Doing regular sports
  • Being involved in another physiotherapy and rehabilitation program related to MS

Treatment and study plan

Pilates Based Core Stabilization Training

Other

Pilates-based core stabilization training (PBCST) is a controlled form of exercise provided improvement in stabilization of abdominal and back muscles.

Home based exercise

Other

Home exercises which include pilates based core stabilization training will be structured for the people with MS according to their physical condition and will perform at home by them.

Primary outcomes

  1. Isokinetic strength

    Time frame: 8 weeks

    Concentric isokinetic muscle strength of the knee flexor and extensor muscles will be evaluated at angular velocities of 30,60 and 90°/s.

  2. Postural sways

    Time frame: 8 weeks

    Postural sways will be evaluated with biodex balance system in different condition such as open eyes on firm and foam surface, closed eyes on firm and foam surface, tandem stance on firm and foam surface,

Secondary outcomes

  1. Core strength

    Time frame: 8 weeks

    Core strength will be evaluated within the scope of core assessment. Curl-Up and Modified Push-Up test will be used for the evaluation of core strength.

  2. Core endurance

    Time frame: 8 weeks

    Core endurance will be evaluated within the scope of core assessment. Trunk Flexor Endurance Test, Trunk Extensor Endurance Test, Trunk Lateral Endurance Test and Plank Test will be used in the evaluation of core endurance.

  3. Balance

    Time frame: 8 weeks

    Berg Balance Scale (BBS) will be used to evaluate balance. BBS is a test developed for functional evaluation of balance in adults. BBS consists of 14 general equilibrium activities that change the orientation of the body center of gravity relative to the support surface and the ability to maintain the static position during the reduction of the support surface. The highest score is 56. The decrease in the score indicates poorer balance.

  4. Mobility

    Time frame: 8 weeks

    Two-minute walk test (2-MWT) will be used to evaluate the mobility of the people with MS. 2-MWT is a measure of self-paced walking ability and functional capacity.

  5. Fatigue

    Time frame: 8 weeks

    Fatigue Severity Scale (FSS) will be used to evaluate fatigue levels. This scale evaluates the severity of fatigue with 9 questions. Each question scores between 1 (I do not agree) and 7 (fully agree). The FSS score is the average value of nine sections. A high score indicates increased fatigue severity.

  6. Quality of life

    Time frame: 8 weeks

    Multiple Sclerosis Quality of Life -54 (MSQOL-54) will be used to evaluate the effectiveness of the treatment on quality of life. The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items into a single instrument.

  7. Fall risk

    Time frame: 8 weeks

    Timed Up and Go (TUG) will be used. TUG is a test used to determine fall risk and measure the progress of balance, sit to stand and walking.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

The Effects of Pilates-Based Core Stabilization Training on Isokinetic Knee Strength and Postural Sway in People With Multiple Sclerosis

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 5, 2020
Registry last updated
Jan 7, 2021

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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