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임상시험 NCT06931522은(는) 다발성 경화증에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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가지 대학교Effects of Mat and Reformer Pilates in Multiple Sclerosis
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임상시험 NCT06931522은(는) 다발성 경화증에 대해 알아보는 중재연구입니다. 현재 상태는 모집중이며, 연구는 2025년 6월 10일에 시작되어 10명의 참여자를 모집하고 있습니다. 가지 대학교이(가) 진행하며, 2025년 9월 1일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 6월 13일에 갱신되었습니다.
간단한 개요
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.
공식 제목
Effects of Mat and Reformer Pilates Training on Postural Adjustments, Balance, and Walking in Patients With Multiple Sclerosis
질환/상태
다발성 경화증출판물
이 임상 시험에 대해 발표된 과학 논문 및 연구 자료.- 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.
기타 연구 식별자
- 2023 - 960
NCT 번호
실제 연구 시작일
2025-06-10
최신 업데이트 게시
2025-06-13
예상 연구 완료일
2025-09-01
계획된 등록 인원
10
연구종류
중재연구
단계/상
해당 없음
상태
모집중
키워드
Multiple Sclerosis
balance
Pilates
gait
balance
Pilates
gait
주요 목적
치료
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
단일맹검
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Mat 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. |
실험적Reformer 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. |
비개입Control group The control group will perform the relaxing exercise at home. | 해당 없음 |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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 |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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 |
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
- 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
가지 대학교119개의 진행 중인 임상시험 탐색 가능연구 책임자
Cagla Ozkul, 책임연구자, PhD, Gazi University
연구 대표 연락처
연락처: Cagla Ozkul, PhD, +903122162678, [email protected]
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