NCT06931522

Brief Summary

Our study aims to investigate the effects of core stability-based Mat Pilates and Equipment-Based Pilates training on anticipatory postural adjustments (APA), balance, and gait in individuals with Multiple Sclerosis (MS). Participants diagnosed with MS will be randomly assigned to Mat Pilates, Equipment-Based Pilates, or a control group. Both Pilates programs will be conducted twice a week for eight weeks. Assessments will be conducted before and after the training period. Anticipatory postural adjustments (APA) will be evaluated using electromyography (EMG) electrodes placed on the Erector Spinae and Tibialis Anterior muscles while participants take a step. Biomechanical responses related to APAs, specifically center of pressure displacement, will be measured using a force platform (Biodex® BioSway). Core endurance will be assessed using the lateral bridge test, Modified Biering-Sorensen test, trunk flexion test, and prone bridge test, while core strength will be evaluated through sit-ups and push-ups. Balance will be measured using posturography. The Activities-Specific Balance Confidence (ABC) Scale will assess confidence in performing daily activities requiring balance. Functional mobility will be evaluated using the Timed Up and Go (TUG) test. Spatiotemporal gait parameters and variability will be analyzed with the BTS® G-WALK system. The Multiple Sclerosis Quality of Life Questionnaire (MSQOL-54) will assess quality of life. This study is unique in that, unlike previous Pilates studies, it will be the first to examine the effects of different Pilates methods on APAs, which are crucial for both locomotor activities and postural stability in individuals with MS. Additionally, it will be the first study to evaluate two commonly used Pilates techniques in terms of their impact on balance and gait.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Jun 2025

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2025

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 17, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

June 10, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2026

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2026

Completed
Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

March 21, 2025

Last Update Submit

March 25, 2026

Conditions

Keywords

Multiple SclerosisbalancePilatesgait

Outcome Measures

Primary Outcomes (3)

  • Anticipatory postural adjustments (APA)

    Data will be collected using an EMG-IMU system (Trigno Avanti, Delsys), with an accelerometer detecting perturbation onset and EMG recording tibialis anterior activity (1000 Hz, 16-bit; SENIAM placement). Participants will stand barefoot on a force platform (feet shoulder-width apart) while perturbations are applied via a 4-kg pendulum. They will receive impacts with both hands at shoulder level and maintain balance. Three trials will be performed. EMG signals will be rectified, low-pass filtered (100 Hz), and analyzed from -600 to +500 ms around perturbation onset (T0). APAs (-100 to +50 ms) will be baseline-corrected and normalized, with mean values used for analysis. CoP data will be recorded during 30-s trials with perturbation at 15 s. CoP ellipse area will be calculated, and the mean of three trials will be analyzed.

    8 weeks

  • Postural stability

    Postural stability will be assessed using a force plate (K-Force, K-Invent), a validated and reliable tool for CoP analysis. Measurements will be taken under eyes-open and eyes-closed conditions, each lasting 30 seconds and repeated three times, with 10-second rests between trials and a 1-minute break between conditions. The primary outcome will be CoP ellipse area (mm²), representing postural sway. Mean values from the three trials for each condition will be used for analysis.

    8 weeks

  • Gait Parameters

    Spatiotemporal gait parameters will be assessed using a wearable inertial sensor system (G-Walk, BTS Bioengineering, Italy). Participants will walk a 10-m distance at a self-selected comfortable speed in three trials. Acceleration data will be sampled at 100 Hz and transmitted via Bluetooth to G-Studio software for analysis. Measured parameters will include gait velocity, cadence, stride length, gait cycle duration, and double support time (% of gait cycle). The mean of the three trials will be used for statistical analysis.

    8 weeks

Secondary Outcomes (1)

  • Mobility

    8 weeks

Study Arms (3)

Mat Pilates

EXPERIMENTAL

In Mat Pilates training, exercise balls and elastic bands will be used. The exercises will be done with 10 repetitions for the first 4 weeks, and with 20 repetitions for the last 4 weeks. The difficulty level of the exercises will be increased in the following weeks according to the patient's condition.

Other: Mat Pilates

Reformer Pilates

EXPERIMENTAL

In the Reformer Pilates group, the difficulty level of the exercises will be provided by different positions, and the springs' resistance will be increased.

Other: Reformer Pilates

Control group

NO INTERVENTION

The control group will perform the relaxing exercise at home.

Interventions

In Mat Pilates training, exercise balls and elastic bands will be used. The exercises will be done with 10 repetitions for the first 4 weeks, and with 20 repetitions for the last 4 weeks. The difficulty level of the exercises will be increased in the following weeks according to the patient's condition.

Mat Pilates

In the Reformer Pilates group, the difficulty level of the exercises will be provided by different positions, and the springs' resistance will be increased.

Reformer Pilates

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of Multiple Sclerosis by a specialist physician
  • Having a disability level between 0-4.5 according to the Expanded Disability Status Scale (EDSS)
  • Being between the ages of 18-65
  • Not having had an attack in the last 3 months
  • Mini-Mental Test score \> 25

You may not qualify if:

  • Having another neurological disorder
  • Having orthopedic, cardiovascular, and pulmonary problems that may affect the research results
  • Having vision, hearing, and perception problems
  • Having a disease that may affect the immune system, such as infection, cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, Turkey (Türkiye)

Location

Related Publications (4)

  • Rodriguez-Fuentes G, Silveira-Pereira L, Ferradans-Rodriguez P, Campo-Prieto P. Therapeutic Effects of the Pilates Method in Patients with Multiple Sclerosis: A Systematic Review. J Clin Med. 2022 Jan 28;11(3):683. doi: 10.3390/jcm11030683.

  • Massot C, Simoneau-Buessinger E, Agnani O, Donze C, Leteneur S. Anticipatory postural adjustment during gait initiation in multiple sclerosis patients: A systematic review. Gait Posture. 2019 Sep;73:180-188. doi: 10.1016/j.gaitpost.2019.07.253. Epub 2019 Jul 19.

  • Sever J, Babic J, Kozinc Z, Sarabon N. Postural Responses to Sudden Horizontal Perturbations in Tai Chi Practitioners. Int J Environ Res Public Health. 2021 Mar 7;18(5):2692. doi: 10.3390/ijerph18052692.

  • 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.

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

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

Study Officials

  • Cagla Ozkul, PhD

    Gazi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 21, 2025

First Posted

April 17, 2025

Study Start

June 10, 2025

Primary Completion

January 23, 2026

Study Completion

February 10, 2026

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations