NCT04252053

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable multiple-sclerosis

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

February 6, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2021

Completed
Last Updated

January 7, 2021

Status Verified

January 1, 2021

Enrollment Period

11 months

First QC Date

January 27, 2020

Last Update Submit

January 6, 2021

Conditions

Keywords

Multiple sclerosisPilatesCore stabilityIsokinetic strengthPostural sway

Outcome Measures

Primary Outcomes (2)

  • Isokinetic strength

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

    8 weeks

  • Postural sways

    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,

    8 weeks

Secondary Outcomes (7)

  • Core strength

    8 weeks

  • Core endurance

    8 weeks

  • Balance

    8 weeks

  • Mobility

    8 weeks

  • Fatigue

    8 weeks

  • +2 more secondary outcomes

Study Arms (2)

Supervised Pilates-Based Core Stability Training Group

EXPERIMENTAL

In order to detect the effects of pilates-based core stabilization training (PBCST) on isokinetic knee strength and postural sways, individuals with MS will receive pilates-based core stabilization training for 8 weeks and 2 days a week. One educational session will perform to teach basic principles of pilates based training. Individuals in this group will receive treatment at the clinic by physiotherapist supervision. All sessions will be individualized (not group training).

Other: Pilates Based Core Stabilization Training

Home exercise group

ACTIVE COMPARATOR

The home exercise group will perform the same PBCST exercises at home during the same period (8 weeks, 2 days a week) as the brochures prepared for them. Individuals in this group will receive one educational session which includes basic principles of pilates and one session which includes two-week exercise program. Participants will be invited to the clinic every two weeks to ensure the progression of the exercises and the exercise program will be updated.

Other: Home based exercise

Interventions

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

Supervised Pilates-Based Core Stability Training Group

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.

Home exercise group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, 34147, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist, Research Assistant

Study Record Dates

First Submitted

January 27, 2020

First Posted

February 5, 2020

Study Start

February 6, 2020

Primary Completion

January 3, 2021

Study Completion

January 3, 2021

Last Updated

January 7, 2021

Record last verified: 2021-01

Locations