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临床试验/NCT04548206
NCT04548206已完成不适用

Effect of Pilates Training on Sensory, Muscle Strength, Balance, and Gait in Patients With Multiple Sclerosis

Gazi University1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2020年9月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
1
主要终点
Vibration sensation

研究概览

简要总结

Knee flexor and extensor muscle weakness in MS patients causes a decrease in walking distance and is an important determinant of walking capacity. Exercise training has beneficial effects on muscle strength, balance, and walking in MS patients. Although the effects of aerobic and resistant exercise training in MS patients are often emphasized, today the effect of different exercise types is also wondered. Pilates is a core stability-based exercise method that improves endurance, flexibility, movement, posture, and respiratory control. The aim of this study is to examine the effect of Pilates training on sensation, muscle strength, balance, and walking in MS patients.

详细描述

Patients with MS between 0-5,5 score according to the Extended Disability Status Scale (EDSS) will be included in the study. The balance, gait, position sense, and muscle strength will be evaluated. The study was designed as a prospective, randomized controlled study. The patients will be randomly assigned to two groups, the "Pilates training" group, and the control group. Pilates training will be performed by the Pilates training group 2 times for 8 weeks under supervision in the outpatient clinic. The control group will be taught relaxation exercises and will be asked to perform the exercises 2 times for 8 weeks at home. Statistical analyses will be performed using the SPSS software version 15 (SPSS Inc. Chicago, IL, USA). The pre-training and post-training measurements of groups will be compared with the paired sample t-test.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •18-65 years of age
  • •Having a diagnosis of "Multiple Sclerosis"
  • •Relapse free in the last 3 mounts
  • •Having an ambulatory status (Expanded Disability Status Scale score ≤ 6 )
  • •No diagnosis of depression

排除标准

  • •Any cardiovascular, orthopedic, visual, hearing and perception problems that may affect the results of the research.

研究组 & 干预措施

Pilates training

Experimental

60 minutes of Pilates training will be performed for 8 weeks.

干预措施: Pilates training (Other)

Control group

Placebo Comparator

The control group will be taught relaxation exercises and will be asked to perform the exercises at home.

干预措施: control (Other)

结局指标

主要结局

Vibration sensation

时间窗: 10 minutes

Duration of vibration sensation will be measured using 128-Hz frequency tuning fork (Elcon1 Medical Instruments, Tuttlingen, Germany).

Two-point discrimination

时间窗: 10 minutes

Two-point discrimination sensation of the foot sole will be evaluated using an aesthesiometer (Baseline1, White Plains, New York, USA).

Position sensation of knee joint

时间窗: 5 minutes

Open kinetic chain position of both knees will be evaluated using a Dualer IQ Digital Inclinometer (J-Tech Medical, Midvale, UT, USA).

Gait

时间窗: 5 minutes

Gait parameters will be assessed via the G-Walk on two separate occasions. The G-Walk is a device that is worn on the waist via an elastic belt. The G-Walk is built with a triaxial accelerometer 16 bit/axes with multiple sensitivity, a triaxial magnetometer 13 bit and a triaxial gyroscope 16 bit/axes with multiple sensitivity. This hardware is capable of acquiring and transmitting data to a computer through a Bluetooth connection and at the end of each analysis an automatic report containing the gait assessment results is ready to be analyzed. Gait symmetry values of the right and left sides are obtained within this report. While the symmetry index ranges from 0 to 100, a value closer to 100 indicates that the gait is more symmetrica.

Balance

时间窗: 10 minutes

The Modified Sensory Organization Test, which is performed using computerized posturography, measures postural sway in response to 4 different sensory conditions is measured using a force platform.

Light touch-pressure sensation

时间窗: 10 minutes

Light touch-pressure sensation will be assessed using a full Semmes-Weinstein Monofilament (SWM) test kit (North Coast Medical, San Jose, CA, USA).

Knee proprioception

时间窗: 10 minutes

Knee proprioception will be evaluated with the active joint reposition test using the isokinetic system (Cybex Norm, Humac, CA, USA).

Position sensation of trunk

时间窗: 10 minutes

Position sensation of trunk will be evaluated using a Dualer IQ Digital Inclinometer (J-Tech Medical, Midvale, UT, USA).

Knee strength

时间窗: 20 minutes

Knee strength will be evaluated using the isokinetic system (Cybex Norm, Humac, CA, USA).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cagla Ozkul

Research Assistant

Gazi University

研究点 (1)

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