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L'essai clinique NCT06931522 pour Sclérose en plaques est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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Effects of Mat and Reformer Pilates in Multiple Sclerosis

En recrutement
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L'étude clinique NCT06931522 est un essai interventionnel pour Sclérose en plaques. Son statut actuel est : en recrutement. L'étude a débuté le 10 juin 2025 et vise à recruter 10 participants. Dirigé par l'Université Gazi, l'essai devrait être terminé d'ici le 1 septembre 2025. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 13 juin 2025.
Résumé succinct
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.

Titre officiel

Effects of Mat and Reformer Pilates Training on Postural Adjustments, Balance, and Walking in Patients With Multiple Sclerosis

Conditions
Sclérose en plaques
Publications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:
Autres identifiants de l'essai
  • 2023 - 960
Numéro NCT
NCT06931522
Date de début (réel)
2025-06-10
Dernière mise à jour publiée
2025-06-13
Date de fin (estimée)
2025-09-01
Inscription (estimée)
10
Type d'essai
Interventionnel
PHASE
N/A
Statut
En recrutement
Mots clés
Multiple Sclerosis
balance
Pilates
gait
Objectif principal
Traitement
Plan d'attribution
Randomisé
Modèle d'intervention
Parallèle
Masquage
Simple aveugle
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalMat 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.
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.
ExpérimentalReformer 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
In the Reformer Pilates group, the difficulty level of the exercises will be provided by different positions, and the springs' resistance will be increased.
Aucune interventionControl group
The control group will perform the relaxing exercise at home.
N/A
Critère principal d'évaluation
Critères d'évaluationDescription de critèresPériode
Anticipatory postural adjustments (APA)
Measurement Tool: Biodex-BioSway™ Portable Balance System Parameters Assessed: Maximum posterior displacement (cm), maximum lateral displacement (cm) Procedure: Participants will take a step following an auditory cue. The magnitude, duration, and latency of medio-lateral and anterior-posterior APAs, as well as the magnitude and speed of the first step, will be recorded separately.
8 weeks
Neuromuscular activation
Measurement Tool: Wireless surface EMG sensors Muscles Assessed: Erector spinae (µV), Tibialis anterior (µV) Procedure: EMG amplitude will be recorded at the onset of APAs, following SENIAM project (Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles) guideline.
8 weeks
Core stability
Core stability will be evaluated in terms of endurance and strength. Core endurance will be measured using the McGill Protocol, which includes the Modified Biering-Sorensen trunk extension test, lateral bridge test, trunk flexion test, and prone bridge test. The results will be recorded in seconds. Core strength will be assessed using sit-ups and modified push-ups, where participants will be asked to complete as many repetitions as possible within 30 seconds.
8 weeks
Postural stability
Measurement Tool: Portable Balance System Parameters Assessed: Total stability index Anterior-posterior stability index Medio-lateral stability index Procedure: Tests performed for 30 seconds (both feet stance) and 10 seconds (single leg stance), repeated three times. Average values will be reported.
8 weeks
Gait kinematics
Measurement Tool: BTS G-WALK sensor system Parameters Assessed: Walking speed (m/s) Cadence (steps/min) Step length (m) Step time (s) Stance time (s) Swing time (s) Double support time (s) Single support time (%) Pelvic angle changes (degrees) Procedure: Participants will walk naturally over a 7-meter course while spatiotemporal parameters are recorded.
8 weeks
Critère secondaire d'évaluation
Critères d'évaluationDescription de critèresPériode
Balance Confidence
The Activities-Specific Balance Confidence (ABC) Scale will be used to assess participants' perceived balance confidence in 16 daily activities, scored from 0% (completely unconfident) to 100% (completely confident). Lower scores indicate a higher risk of balance impairment and falls.
8 weeks
Mobility
Functional mobility will be evaluated using the Timed Up and Go (TUG) test. Participants will be asked to stand up from a chair, walk 3 meters, turn around, return, and sit back down. The test will begin with a verbal "go" command, and the completion time will be recorded in seconds using a stopwatch.
8 weeks
Fatigue severity
Fatigue levels will be assessed using the Fatigue Severity Scale (FSS), a 9-item scale where each item is scored from 1 to 7. A total score of 28 or higher indicates severe fatigue, making it particularly useful for individuals with Multiple Sclerosis (MS).
8 weeks
Quality of life
Quality of life will be evaluated using the Multiple Sclerosis Quality of Life-54 (MSQOL-54) questionnaire. This 54-item instrument generates 12 subscales along with two summary scores, and two additional single-item measures. The subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function. The summary scores are the physical health composite summary and the mental health composite summary. The single item measures are satisfaction with sexual function and change in health. This questionnaire, which has been validated in Turkish, will offer a comprehensive assessment of the quality of life in individuals with MS.
8 weeks
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
  • 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

  • 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
Gazi University logoUniversité Gazi119 essais cliniques actifs à explorer
Partie responsable de l'essai
Cagla Ozkul, Investigateur principal, PhD, Gazi University
Contact central de l'essai
Contact: Cagla Ozkul, PhD, +903122162678, [email protected]
1 Centres de l'essai dans 1 pays
Gazi University, Ankara, Turkey (Türkiye)
Cagla Ozkul, Contact, [email protected]
Cagla Ozkul, Investigateur principal
En recrutement