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

This study has been completed.
Sponsor:
Collaborator:
Réseau d'études appliquées des pratiques de Santé de Réadapation (ré)insertion
Information provided by:
Haute Ecole Cantonale Vaudoise de Santé
ClinicalTrials.gov Identifier:
NCT01281085
First received: January 20, 2011
Last updated: April 13, 2011
Last verified: April 2011
  Purpose

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
Shoulder Pain

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Validation of a Kinematic Functional Shoulder Score Including Only Essential Movements: a Pilot Study

Further study details as provided by Haute Ecole Cantonale Vaudoise de Santé:

Primary Outcome Measures:
  • variability of kinematic simplified functional score [ Time Frame: only one measurement session ] [ Designated as safety issue: No ]
    This pilot study mainly aims at defining how many tests replications are needed to obtain a reliable shoulder function measurement


Secondary Outcome Measures:
  • intra- and inter-reproducibility of kinematic functional shoulder score [ Time Frame: only one measurement session ] [ Designated as safety issue: No ]
    As measurement are performed twice respectively by two evaluators, this pilot study will provide a first insight of test reliability


Enrollment: 16
Study Start Date: October 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01281085

Locations
Switzerland
Département de l'Appareil Locomoteur - CHUV
Lausanne, Switzerland, 1005
Sponsors and Collaborators
Haute Ecole Cantonale Vaudoise de Santé
Réseau d'études appliquées des pratiques de Santé de Réadapation (ré)insertion
Investigators
Principal Investigator: Claude A. Pichonnaz, PT MSc HECVSanté and CHUV-UNIL
  More Information

Publications:
Responsible Party: Claude Pichonnaz, HES professor, HECVSanté, filière physiothérapie
ClinicalTrials.gov Identifier: NCT01281085     History of Changes
Other Study ID Numbers: SAGEX-24519
Study First Received: January 20, 2011
Last Updated: April 13, 2011
Health Authority: Switzerland: Federal Office of Public Health

Keywords provided by Haute Ecole Cantonale Vaudoise de Santé:
Shoulder
Outcome treatment
Validation Studies
Biomechanics

Additional relevant MeSH terms:
Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 16, 2014