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临床试验/NCT05782439
NCT05782439已完成不适用

Detection of the Ileotibial Band Tension Through Direct Palpation: a Reliability Assessment Study

Manusapiens2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年11月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
2
主要终点
Precision of the palpation test

研究概览

简要总结

The goal of this clinical-test study is to evaluate the reliability of the direct palpation of the ileotibial band. For this purpose, a group of 100 healthy subjects will be considered. The main question it aims to answer regards the reproducibility of the intra and inter examiner evaluation performed on the same day (intra-day) and the validation of the palpatory examination with an instrumental measure of the tissue tension.

Participants will undergo a manual and instrumental sampling of the ileotibial band tension of both legs.

详细描述

The project includes 6 phases:

I phase - agreement in principle on the method of collection; II phase - recruitment; III phase - first sampling; IV phase - training on perception and concordance; V phase - second sampling to verify the progression of the agreement; VI phase - third manual sampling and evaluation with Myoton.

Description of the phases

Phase I - Two examiners together with the principal investigator perform 2 hours of training to standardize the sampling method (localization of the point to be evaluated of the Iileotibial band -ITB- and intensity of pressure of the fingertips to be used) and discussion on the tension gradation detected on the ITB with some volunteers.

Phase II - The recruitment will be carried out through the search for volunteers among the students of the OSCE-Bologna school of osteopathy, through announcement in the classroom and publication of the recruitment in the FB social group of the school (OSCE planet) and WhatsApp groups of students organized by year .

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • healthy subjects

排除标准

  • clinically evident painful symptoms that, in the opinion of the subject himself or the examiner, may prevent the test from being carried out (for example, pain in the hip while maintaining the sampling position);
  • evident excess weight (BMI greater than 28 kg / m2) which may make the manual and instrumental result obtained doubtful.

结局指标

主要结局

Precision of the palpation test

时间窗: 5 seconds for each evaluation (day 1)

intra-day concordance intra and inter examiners by means of weighted Cohen's K with use of sampling evaluation divided into 3 intervals (+1, 0, -1) and 7 intervals (+3, +2, +1, 0, -1, -2, -3)

次要结局

  • Accuracy of the palpation test(5 seconds for each evaluation (day 1))
  • Effect of training(5 seconds for each evaluation (day 1))

研究者

发起方
Manusapiens
申办方类型
Other
责任方
Sponsor

研究点 (2)

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