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临床试验 NCT06931522 针对多发性硬化症目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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加齐大学Effects of Mat and Reformer Pilates in Multiple Sclerosis
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临床试验NCT06931522是一项针对多发性硬化症的干预性研究试验，目前试验状态为招募中。试验始于2025年6月10日，计划招募10名患者。该研究由加齐大学主导，预计于2025年9月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年6月13日。
简要概括
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.
官方标题
Effects of Mat and Reformer Pilates Training on Postural Adjustments, Balance, and Walking in Patients With Multiple Sclerosis
疾病
多发性硬化症出版物
关于此临床试验发表的科学文章和研究论文：- 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.
其他研究标识符
- 2023 - 960
NCT编号
实际开始日期
2025-06-10
最近更新发布
2025-06-13
预计完成日期
2025-09-01
计划入组人数
10
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
招募中
关键词
Multiple Sclerosis
balance
Pilates
gait
balance
Pilates
gait
主要目的
治疗方法
分配方式
随机
干预模型
平行
盲法
单盲
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性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. | 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. |
实验性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. | 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. |
无干预Control group The control group will perform the relaxing exercise at home. | 不适用 |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
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 |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
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 |
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- 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
加齐大学119 个活跃的临床试验可供探索研究责任方
Cagla Ozkul, 主要研究者, PhD, Gazi University
研究中心联系人
联系人: Cagla Ozkul, PhD, +903122162678, [email protected]
1 位于 1 个国家/地区的研究中心