Validation of a Score for Shoulder Function Evaluation Based on Movement Analysis
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|ClinicalTrials.gov Identifier: NCT01281085|
Recruitment Status : Completed
First Posted : January 21, 2011
Last Update Posted : April 14, 2011
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.
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||16 participants|
|Official Title:||Validation of a Kinematic Functional Shoulder Score Including Only Essential Movements: a Pilot Study|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||April 2011|
Shoulder conditions including rotator cuff condition treated conservatively, shoulder instability treated conservatively, diaphyseal humerus fracture or subcapital humerus fracture treated surgically and frozen shoulder
- variability of kinematic simplified functional score [ Time Frame: only one measurement session ]This pilot study mainly aims at defining how many tests replications are needed to obtain a reliable shoulder function measurement
- intra- and inter-reproducibility of kinematic functional shoulder score [ Time Frame: only one measurement session ]As measurement are performed twice respectively by two evaluators, this pilot study will provide a first insight of test reliability
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01281085
|Département de l'Appareil Locomoteur - CHUV|
|Lausanne, Switzerland, 1005|
|Principal Investigator:||Claude A. Pichonnaz, PT MSc||HECVSanté and CHUV-UNIL|