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临床试验/NCT05844800
NCT05844800已完成不适用

The Effect of Surgical Repair of Chest on Postural Stability Among Patients With Pectus Excavatum

Poznan University of Physical Education2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2011年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
43
试验地点
2
主要终点
Postural Stability

研究概览

简要总结

The goal of this study is to determine the effect of Nuss minimally-invasive repair technique of pectus excavatum (PE) on the postural stability in patients with PE.

The main questions it aims to answer are:

  • How surgical chest wall repair will affect postural stability of PE patients?
  • What is the difference in postural stability between patients with PE and healthy controls? Participants will undergo the Nuss repair surgery and will be tested before and afterwards for their postural stability with the use of the posturography method.

Researchers will compare PE male patients and healthy young men to see if PE posture defect affects postural stability.

详细描述

The experiment was designed as a pretest-posttest control trial. The clinical examination and surgery intervention (minimally invasive repair of pectus excavatum - MIRPE) of pectus excavatum patients are done in Wielkopolska Centre of Pulmonology and Thoracosurgery in Poznań, Poland. Other postural stability assessment of both, experimental group and control group subjects are done in the Poznań University of Physical Education in Poland. The measurements are carried out twice, before and three months after the intervention for experimental group, and twice for control group as well. Before the experiment initial measurements connected to basic and somatic characteristics assessments are recorded. Participants are also familiarized with measurement methods.

All PE patients included in the study after preoperative examination undergo the Nuss surgery procedure (MIRPE): curved metal bars are inserted behind the sternum to correct the shape of the anterior chest wall. The bars are left in situ for three years and then removed. The operation is performed under general anesthesia in a hospital setting.

Postural stability as a dependent variable was examined with the use of the posturography method based on the measurement of centre of pressure (COP) displacements. The stabilometric platform CQStab2P in two-plates version (CQ Electronic System, Poland) is used for collecting COP data during trials. The platforms are equipped with strain gauges that facilitated the monitoring of the changes in ground reaction forces. It is connected to a computer equipped with software provided by the manufacturer of the platforms. Based on the data of ground reaction forces the position and displacements of COP are estimated in the software.

The sampling frequency of 200 Hz is used during data acquisition. According to producer declaration processing accurancy is equal to 0.1% (12-bit processing, effective 10-bit) during reproduction of statokinesiogram with accurancy of 1 mm with radius fluctuation of 10cm.

The force platforms are placed on a hard and flat floor surface. Before the start of the testing procedures, the participants rest in a sitting position for 5 min. During the measurement, only the researcher and the participant are present in the room. Participants need to perform trials in three conditions: 1) double stance with eyes open (EO); 2) double stance with eyes closed (EC); 3) one-leg standing with eyes open (OLS).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
14 Years 至 —(Child, Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • pectus excavatum (experimental group)
  • no posture defects (control group)
  • no neurological disorders
  • consent to the surgical intervention procedure (experimental group)

排除标准

  • co-existence of defects in the anterior chest wall other than pectus excavatum
  • presence of musculoskeletal anomalies

研究组 & 干预措施

Pectus Excavatum

Experimental

Patients included in the study after preoperative examination underwent the Nuss surgery procedure - a minimally-invasive repair technique of Pectus Excavatum (MIRPE)

干预措施: Nuss repair of Pectus Excavatum (Procedure)

Pectus Excavatum

Experimental

Patients included in the study after preoperative examination underwent the Nuss surgery procedure - a minimally-invasive repair technique of Pectus Excavatum (MIRPE)

干预措施: Epidural anesthesia (Drug)

结局指标

主要结局

Postural Stability

时间窗: Three months

Postural stability as a dependent variable examined with the use of the posturography method based on the measurement of Centre of Pressure displacements.

次要结局

  • BMI(Single measurement)

研究者

发起方
Poznan University of Physical Education
申办方类型
Other
责任方
Sponsor

研究点 (2)

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