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Validation of a Score for Shoulder Function Evaluation Based on Movement Analysis

2011年4月13日 更新者:Haute Ecole de Santé Vaud

Validation of a Kinematic Functional Shoulder Score Including Only Essential Movements: a Pilot Study

Questionnaires are frequently used to evaluate shoulder function in various diseases or after surgery. However, measurement of shoulder function is presently a controversial issue. Shoulder movement analysis based on embedded sensors could be a promising alternative to questionnaires. Some studies already demonstrated the relevance of this approach. It has also been demonstrated that a simple testing procedure including only two arm movements produces comparable results to more complicated testing procedures. However, more studies are needed to extensively establish if this simplified testing procedure provides a trustworthy evaluation of patient shoulder function and its evolution.

This study is a preliminary study which aims to develop a precise testing procedure which will be used in a future study aiming to evaluate measurement properties of a simple shoulder function test based on movement sensors.

研究概览

地位

完全的

条件

详细说明

Background Measurement of shoulder function is a controversial issue. There is a great variety of measurement tools but none of them has been universally accepted. There is therefore a need to develop extensively validated and convenient measurement tools.

Embedded computerized movement analysis can potentially meet these requirements for measurement of shoulder function. Ambulatory measurement devices allow application in various clinical conditions, display adequate precision and accuracy, and are considerably more straightforward than laboratory-based systems.

Using a Physilog ® II embedded system, Coley (2007) developed a relatively simple score of shoulder function (P Score). The method is based on arm power measurement by three-dimensional accelerometers and gyroscopes during seven consecutive shoulder movements. It demonstrated reliability, responsiveness and criterion-based validity. However, additional knowledge and technological progress could now contribute to further simplification of the.

A secondary analysis of Coley's study data based on principal component analysis and multiple regressions highlighted that a procedure including only two selected movements produces comparable results to P Score. Moreover, the development of wireless systems considerably simplifies set up. Consequently, simpler but equivalent measurement procedure can now be considered.

However some important issues have to be clarified before an extensive validation study can be undertaken. The simplicity of the testing procedure allows test replication. However, the number of movement replications needed to obtain a reliable outcome is presently unknown. Relevance of testing procedure and study feasibility have also to be evaluated. A pilot study is needed to clarify these issues.

Aim The aim of this pilot study is to determine the number of movement replications needed to obtain a reliable result using a simplified cinematic shoulder measurement procedure as well as to evaluate testing procedure and study protocol.

Methods Measurement will be carried out with four groups of patients presenting with frequent shoulder conditions (rotator cuff condition, shoulder instability, diaphyseal or subcapital humerus fracture, frozen shoulder). Measurement procedure includes two consecutive measurements, alternatively conducted by two evaluators. Currently used functional questionnaires will be completed at both stages.

Statistical analysis will address outcome variability according to number of replications and reproducibility.

研究类型

观察性的

注册 (实际的)

16

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Lausanne、瑞士、1005
        • Département de l'Appareil Locomoteur - CHUV

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients diagnosed with a shoudler condition, as stated during the medical examination performed at the specialized shoulder consultation of the hospital

描述

Inclusion Criteria:

  • Rotator cuff condition, conservative treatment indicated
  • Shoulder instability, conservative treatment indicated
  • Diaphyseal humerus fracture or subcapital humerus fracture treated surgically, at 6 weeks post surgery
  • Frozen shoulder, conservative treatment indicated

Exclusion Criteria:

  • Bilateral shoulder condition or other shoulder condition than the ones mentioned in inclusion criteria
  • Any concomitant pain or condition involving upper limb
  • Cervical spine condition involving upper limb pain or mobility restriction
  • Insufficient French language level to understand patient information form, consent form or questionnaires
  • Insufficient ability to give truly informed consent or to understand questionnaires. It will be proceeded to a Mini Mental State score in case of uncertainty, with exclusion criteria at 24 points/30 (ANAES 2000).
  • Medical contraindication to execute movements required for score completion
  • Tumor
  • Neurological condition interfering with test

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
No treatment
Shoulder conditions including rotator cuff condition treated conservatively, shoulder instability treated conservatively, diaphyseal humerus fracture or subcapital humerus fracture treated surgically and frozen shoulder

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
variability of kinematic simplified functional score
大体时间:only one measurement session
This pilot study mainly aims at defining how many tests replications are needed to obtain a reliable shoulder function measurement
only one measurement session

次要结果测量

结果测量
措施说明
大体时间
intra- and inter-reproducibility of kinematic functional shoulder score
大体时间:only one measurement session
As measurement are performed twice respectively by two evaluators, this pilot study will provide a first insight of test reliability
only one measurement session

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Claude A. Pichonnaz, PT MSc、HECVSanté and CHUV-UNIL

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年10月1日

初级完成 (实际的)

2011年4月1日

研究完成 (实际的)

2011年4月1日

研究注册日期

首次提交

2011年1月20日

首先提交符合 QC 标准的

2011年1月20日

首次发布 (估计)

2011年1月21日

研究记录更新

最后更新发布 (估计)

2011年4月14日

上次提交的符合 QC 标准的更新

2011年4月13日

最后验证

2011年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • SAGEX-24519

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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