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临床试验/NCT06201403
NCT06201403招募中不适用

Mechanical Properties of Peripheral and Accessory Respiratory Muscles in Chronic Obstructive Pulmonary Disease Patients

Istanbul Medipol University Hospital1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2024年1月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
66
试验地点
1
主要终点
M.Sternocleidomastoideus (SCM) myotonometric measurement

研究概览

简要总结

The biomechanical properties of accessory respiratory muscles and peripheral muscles of COPD and healthy subjects will be measured and compared with the MyotonPro device.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being diagnosed with group C and D COPD according to GOLD staging
  • Having been using the same medications for the last 4 weeks
  • No additional comorbid diseases of the orthopedic, neurological or cardiac system

排除标准

  • Presence of another respiratory system disease other than COPD
  • Patients who have had an acute COPD exacerbation in the last 4 weeks
  • Patients experiencing COPD exacerbations during the study protocol
  • Presence of fatty tissue at the measurement points, which may impair the measurement quality.
  • Have already participated in another clinical trial within the last 30 days that may affect the results of the study.
  • Inclusion Criteria for Healthy Cases
  • Being over 18 years of age
  • Not having any diagnosed chronic disease
  • Not being a smoker

结局指标

主要结局

M.Sternocleidomastoideus (SCM) myotonometric measurement

时间窗: 107 millisecond

To measure the tension of the SCM, participants will be asked to lie supine on the bed. The evaluator will mark the central point with a pencil on the line connecting the mastoid process and the clavicle bone and then take the measurement. The physiotherapist will hold the device vertically and apply downward pressure (18N) to the muscle body. When the red light on the plexiglass frame of the device probe turns green, the pressure application will be stopped and will remain constant until 5 strokes are made. In every 5 beats, the duration of 1 beat is 15 ms and the time between beats is 8 ms. The SENIAM sensor location guide will be considered as a reference for the estimated motor point determination in the MyotonPRO measurement

M. Pectoralis Major (PM) myotonometric measurement

时间窗: 107 millisecond

To measure the muscular characteristics of the PM, participants will be asked to lie in a supine position with their hips neutrally positioned and their knees fully extended. The measurement point of PM is the intersection of the vertical line from the midpoint of the clavicle and the horizontal line from the axilla. The physiotherapist will hold the device vertically and apply downward pressure (18N) to the muscle body. When the red light on the plexiglass frame of the device probe turns green, the pressure application will be stopped and will remain constant until 5 strokes are made. In every 5 beats, the duration of 1 beat is 15 ms and the time between beats is 8 ms. The SENIAM sensor location guide will be considered as a reference for the estimated motor point determination in the MyotonPRO measurement

M. Trapezius myotonometric measurement

时间窗: 107 millisecond

Participants will be instructed to sit comfortably in a chair with back support, lean their hips against the back of the chair, and keep their pelvis stationary with their feet on the floor and their hands in their lap. The shoulders will be in a neutral position, the knee and hip joints will be flexed to 90 degrees, and the trunk will remain upright. The measurement point of the upper trapezius is the midpoint of the connection between C7 and the acromion. The physiotherapist will hold the device vertically and apply downward pressure (18N) to the muscle body. When the red light on the plexiglass frame of the device probe turns green, the pressure application will be stopped and will remain constant until 5 strokes are made. In every 5 beats, the duration of 1 beat is 15 ms and the time between beats is 8 ms. The SENIAM sensor location guide will be considered as a reference for the estimated motor point determination in the MyotonPRO measurement

M. Biceps brachii myotonometric measurement

时间窗: 107 millisecond

While the participants are in a supine position, measurements will be taken from the middle between the lateral acromion and the medial border of the cubital fossa. The physiotherapist will apply downward pressure (18N) to the muscle body by holding the device vertically. When the red light on the plexiglass frame of the device probe turns green, the pressure application will be stopped and will remain constant until 5 strokes are made. In every 5 beats, the duration of 1 beat is 15 ms and the time between beats is 8 ms. The SENIAM sensor location guide will be considered as a reference for the estimated motor point determination in the MyotonPRO measurement

M.Vastus lateralis myotonometric measurement

时间窗: 107 millisecond

While the participants are in the supine position, measurement will be taken from the midpoint of the line from the upper pole of the patella to the greater trochanter. The physiotherapist will apply downward pressure (18N) to the muscle body by holding the device vertically. When the red light on the plexiglass frame of the device probe turns green, the pressure application will be stopped and will remain constant until 5 strokes are made. In every 5 beats, the duration of 1 beat is 15 ms and the time between beats is 8 ms. The SENIAM sensor location guide will be considered as a reference for the estimated motor point determination in the MyotonPRO measurement

M. Tibialis anterior myotonometric measurement

时间窗: 107 millisecond

While the participants are in the supine position, measurements will be taken from the head of the fibula to the medial malleolus and 2 cm laterally from one-third of the tibia. The physiotherapist will apply downward pressure (18N) to the muscle body by holding the device upright. When the red light on the plexiglass frame of the device probe turns green, the pressure application will be stopped and will remain constant until 5 strokes are made. In every 5 beats, the duration of 1 beat is 15 ms and the time between beats is 8 ms. The SENIAM sensor location guide will be considered as a reference for the estimated motor point determination in the MyotonPRO measurement

M. Rectus abdominis (RA) myotonometric measurement

时间窗: 107 millisecond

Participants will lie in a supine position, with bilateral legs hip-knee flexed, feet supported on the bed. The muscle tone of the RA muscle portion will be measured from a point approximately 3 cm next to the belly button. The probe will be placed perpendicular to the surface and pressure will be applied until the probe turns green. The physiotherapist will hold the device vertically and apply downward pressure (18N) to the muscle body. When the red light on the plexiglass frame of the device probe turns green, the pressure application will be stopped and will remain constant until 5 strokes are made. In every 5 beats, the duration of 1 beat is 15 ms and the time between beats is 8 ms. The SENIAM sensor location guide will be considered as a reference for the estimated motor point determination in the MyotonPRO measurement

M.Rectus femoris myotonometric measurement

时间窗: 107 millisecond

While the participants are in the supine position, measurements will be taken from the midpoint between the SIPS and the top of the patella. The physiotherapist will hold the device upright and apply downward pressure (18N) to the muscle body. When the red light on the plexiglass frame of the device probe turns green, the pressure application will be stopped and will remain constant until 5 strokes are made. In every 5 beats, the duration of 1 beat is 15 ms and the time between beats is 8 ms. The SENIAM sensor location guide will be considered as a reference for the estimated motor point determination in the MyotonPRO measurement

次要结局

未报告次要终点

研究者

发起方
Istanbul Medipol University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

esra pehlivan

Assoc. Prof. Dr.

Saglik Bilimleri Universitesi

研究点 (1)

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