NCT04548206

Brief Summary

Knee flexor and extensor muscle weakness in MS patients causes a decrease in walking distance and is an important determinant of walking capacity. Exercise training has beneficial effects on muscle strength, balance, and walking in MS patients. Although the effects of aerobic and resistant exercise training in MS patients are often emphasized, today the effect of different exercise types is also wondered. Pilates is a core stability-based exercise method that improves endurance, flexibility, movement, posture, and respiratory control. The aim of this study is to examine the effect of Pilates training on sensation, muscle strength, balance, and walking in MS patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Sep 2020

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 14, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

September 14, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2022

Completed
Last Updated

August 5, 2022

Status Verified

August 1, 2022

Enrollment Period

1.9 years

First QC Date

September 7, 2020

Last Update Submit

August 4, 2022

Conditions

Keywords

Multiple SclerosissensationgaitPilates

Outcome Measures

Primary Outcomes (9)

  • Gait

    Gait parameters will be assessed via the G-Walk on two separate occasions. The G-Walk is a device that is worn on the waist via an elastic belt. The G-Walk is built with a triaxial accelerometer 16 bit/axes with multiple sensitivity, a triaxial magnetometer 13 bit and a triaxial gyroscope 16 bit/axes with multiple sensitivity. This hardware is capable of acquiring and transmitting data to a computer through a Bluetooth connection and at the end of each analysis an automatic report containing the gait assessment results is ready to be analyzed. Gait symmetry values of the right and left sides are obtained within this report. While the symmetry index ranges from 0 to 100, a value closer to 100 indicates that the gait is more symmetrica.

    5 minutes

  • Balance

    The Modified Sensory Organization Test, which is performed using computerized posturography, measures postural sway in response to 4 different sensory conditions is measured using a force platform.

    10 minutes

  • Light touch-pressure sensation

    Light touch-pressure sensation will be assessed using a full Semmes-Weinstein Monofilament (SWM) test kit (North Coast Medical, San Jose, CA, USA).

    10 minutes

  • Vibration sensation

    Duration of vibration sensation will be measured using 128-Hz frequency tuning fork (Elcon1 Medical Instruments, Tuttlingen, Germany).

    10 minutes

  • Two-point discrimination

    Two-point discrimination sensation of the foot sole will be evaluated using an aesthesiometer (Baseline1, White Plains, New York, USA).

    10 minutes

  • Position sensation of knee joint

    Open kinetic chain position of both knees will be evaluated using a Dualer IQ Digital Inclinometer (J-Tech Medical, Midvale, UT, USA).

    5 minutes

  • Knee proprioception

    Knee proprioception will be evaluated with the active joint reposition test using the isokinetic system (Cybex Norm, Humac, CA, USA).

    10 minutes

  • Position sensation of trunk

    Position sensation of trunk will be evaluated using a Dualer IQ Digital Inclinometer (J-Tech Medical, Midvale, UT, USA).

    10 minutes

  • Knee strength

    Knee strength will be evaluated using the isokinetic system (Cybex Norm, Humac, CA, USA).

    20 minutes

Study Arms (2)

Pilates training

EXPERIMENTAL

60 minutes of Pilates training will be performed for 8 weeks.

Other: Pilates training

Control group

PLACEBO COMPARATOR

The control group will be taught relaxation exercises and will be asked to perform the exercises at home.

Other: control

Interventions

The program consisted of core-based Pilates exercises on the mat for 60 minutes.

Pilates training
controlOTHER

The program consisted of progressive relaxation exercises at home.

Control group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • Having a diagnosis of "Multiple Sclerosis"
  • Relapse free in the last 3 mounts
  • Having an ambulatory status (Expanded Disability Status Scale score ≤ 6 )
  • No diagnosis of depression

You may not qualify if:

  • Any cardiovascular, orthopedic, visual, hearing and perception problems that may affect the results of the research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, Turkey (Türkiye)

Location

Related Publications (2)

  • Citaker S, Gunduz AG, Guclu MB, Nazliel B, Irkec C, Kaya D. Relationship between foot sensation and standing balance in patients with multiple sclerosis. Gait Posture. 2011 Jun;34(2):275-8. doi: 10.1016/j.gaitpost.2011.05.015. Epub 2011 Jun 16.

    PMID: 21683600BACKGROUND
  • Bulguroglu I, Guclu-Gunduz A, Yazici G, Ozkul C, Irkec C, Nazliel B, Batur-Caglayan HZ. The effects of Mat Pilates and Reformer Pilates in patients with Multiple Sclerosis: A randomized controlled study. NeuroRehabilitation. 2017;41(2):413-422. doi: 10.3233/NRE-162121.

    PMID: 28946576BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Study Officials

  • Cagla Ozkul, Phd

    Gazi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: prospective randomize controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

September 7, 2020

First Posted

September 14, 2020

Study Start

September 14, 2020

Primary Completion

July 29, 2022

Study Completion

July 29, 2022

Last Updated

August 5, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations