- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06931522
Effects of Mat and Reformer Pilates in Multiple Sclerosis
Effects of Mat and Reformer Pilates Training on Postural Adjustments, Balance, and Walking in Patients With Multiple Sclerosis
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ankara, Turkey (Türkiye)
- Gazi University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mat Pilates
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.
|
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.
|
|
Experimental: Reformer 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.
|
In the Reformer Pilates group, the difficulty level of the exercises will be provided by different positions, and the springs' resistance will be increased.
|
|
No Intervention: Control group
The control group will perform the relaxing exercise at home.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anticipatory postural adjustments (APA)
Time Frame: 8 weeks
|
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
Time Frame: 8 weeks
|
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
Time Frame: 8 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mobility
Time Frame: 8 weeks
|
Functional mobility will be assessed using the Timed Up and Go (TUG) test, a reliable and valid clinical measure.
Participants will stand up from a chair, walk 3 m, turn, return, and sit down.
After one familiarization trial, three trials will be recorded, and the mean value will be used for analysis.
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Cagla Ozkul, PhD, Gazi University
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023 - 960
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Multiple Sclerosis
-
University Hospital, Basel, SwitzerlandSwiss National Science FoundationRecruitingMultiple Sclerosis (MS) | Relapsing-remitting Multiple Sclerosis (RRMS) | Secondary-progressive Multiple Sclerosis (SPMS) | Primary Progressive Multiple Sclerosis (PPMS)Switzerland
-
University of California, Los AngelesUnknownRelapsing-remitting Multiple Sclerosis | Secondary-progressive Multiple Sclerosis | Primary-progressive Multiple SclerosisUnited States
-
BiogenCompletedMultiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Remittent ProgressiveJapan
-
Cabaletta BioNot yet recruitingProgressive Multiple Sclerosis | Multiple Sclerosis | Multiple Sclerosis (Relapsing Remitting) | Relapsing Multiple Sclerosis (RMS) | Progressive Multiple Sclerosis (PMS) | Multiple Sclerosis (MS) - Relapsing-remitting | Multiple Sclerosis - Relapsing Remitting
-
Rigshospitalet, DenmarkOdense University Hospital; Aarhus University Hospital; Hvidovre University Hospital and other collaboratorsActive, not recruitingRelapsing Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisDenmark
-
The Cleveland ClinicUniversity Hospitals Cleveland Medical CenterCompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Progressive Relapsing Multiple SclerosisUnited States
-
Icahn School of Medicine at Mount SinaiColumbia University; New York Stem Cell Foundation Research InstituteCompletedClinically Isolated Syndrome | Relapsing-Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
-
Novartis PharmaceuticalsCompletedRelapsing-remitting Multiple Sclerosis | Active Secondary Progressive Multiple SclerosisJapan
-
Banc de Sang i TeixitsVall d'Hebron Research Institute (VHIR)CompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple SclerosisSpain
-
BiogenElan PharmaceuticalsCompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
Clinical Trials on Mat Pilates
-
Uskudar UniversityCompletedOccupational DiseasesTurkey (Türkiye)
-
Uskudar UniversityCompletedLow Back Pain | Kinesiophobia | Disc HerniationTurkey (Türkiye)
-
Osmaniye Korkut Ata UniversityCompletedSports, MechanicalTurkey
-
Bulent Ecevit UniversityIstanbul Arel UniversityCompletedExercise | Health-Related Behavior | Healthcare ProvidersTurkey
-
Izmir Katip Celebi UniversityEnrolling by invitation
-
Marymount UniversityTexas Tech University; University of Isfahan; Busan UniversityCompleted
-
Riphah International UniversityCompletedObese WomenPakistan
-
Badr UniversityNot yet recruiting
-
Federal University of São PauloFundação de Amparo à Pesquisa do Estado de São PauloCompleted
-
Universidade Federal de Santa MariaCompleted