Validation of a Kinematic Functional Shoulder Score Including Only Essential Movements

NCT ID: NCT01431417

Last Updated: 2015-06-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 108 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2014-05-31

Brief Summary

A lot of shoulder function evaluation scores exist but none has been universally accepted as a gold standard.

Recent studies have demonstrated the potential of computerized movement analysis with embedded sensors for objective evaluation of shoulder functional outcome following surgery.

A very simple testing procedure is possible as just a few repetitions of two simple shoulder movements are sufficient. This could potentially facilitate implementation of shoulder function movement analysis in current clinical practice.

However, at the present stage of development, the method needs to be extensively validated. This means that the research will intend to determine precisely for which current shoulder pathology it can be applied, what the outcome of healthy people is, what the reliability of the score is and how it can monitor patient evolution.

Detailed Description

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 testing procedure.

Indeed, 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.

A pilot study (ClinicalTrials.gov identifier: NCT01281085) has been conducted to prepare this study. it contributed to determine the number of replications of movements needed and to refine the testing procedure.

The aim of this study is to proceed to an extensive validation study of the simplified testing procedure. Kinematic measurements 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) and a group of healthy people. Measurement procedure includes two consecutive measurements, alternatively conducted by two evaluators and measured simultaneously by two different movement analysis systems. Currently used functional questionnaires will be completed at both stages for comparison. Measurement will be performed at baseline and 6 months later.

Statistical analysis will address reproducibility, responsiveness, minimal clinically important difference and correlation with current clinical scores.

Conditions

Rotator Cuff, Syndrome; Frozen Shoulder; Humerus, Fracture; Other Instability of Joint, Shoulder Region

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy volunteers

Healthy volunteers, less than 35 years old and presenting with no shoulder condition

No interventions assigned to this group

Patients with rotator cuff condition

Patients with rotator cuff condition, conservative treatment indicated

No interventions assigned to this group

Patients with shoulder instability

Patients with shoulder instability, conservative treatment indicated

No interventions assigned to this group

Patients with proximal humerus fracture

Patients with diaphyseal humerus fracture or subcapital humerus fracture treated surgically or conservatively, at 6 weeks post stabilization. (Surgical and conservative treatment will be considered as the same population from the functional point of view as functional outcome is similar) (Handoll et al. 2003).

No interventions assigned to this group

Patients with frozen shoulder

Patients with frozen shoulder, conservative treatment indicated

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Rotator cuff condition, conservative treatment indicated
• Shoulder instability, conservative treatment indicated
• Diaphyseal humerus fracture or subcapital humerus fracture treated surgically or conservatively, at 6 weeks post stabilization. (Surgical and conservative treatment will be considered as the same population from the functional point of view as functional outcome is similar) (Handoll et al. 2003).
• Frozen shoulder, conservative treatment indicated

• 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

Exclusion Criteria

• Medical contraindication to execute movements required for score completion
• Tumor
• Neurological condition interfering with test

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Swiss National Science Foundation

OTHER

Sponsor Role: collaborator

Haute Ecole de Santé Vaud

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claude A. Pichonnaz, PT MSc

Role: STUDY_DIRECTOR

HESAV and University Hospital of Lausanne

Farron Alain, MER PD

Role: STUDY_CHAIR

University of Lausanne Hospitals

Locations

Département de l'Appareil Locomoteur - CHUV

Lausanne, , Switzerland

Countries

Switzerland

References

Coley B, Jolles BM, Farron A, Bourgeois A, Nussbaumer F, Pichonnaz C, Aminian K. Outcome evaluation in shoulder surgery using 3D kinematics sensors. Gait Posture. 2007 Apr;25(4):523-32. doi: 10.1016/j.gaitpost.2006.06.016. Epub 2006 Aug 28.

Reference Type: BACKGROUND

PMID: 16934979 (View on PubMed)

Jolles BM, Duc C, Coley B, Aminian K, Pichonnaz C, Bassin JP, Farron A. Objective evaluation of shoulder function using body-fixed sensors: a new way to detect early treatment failures? J Shoulder Elbow Surg. 2011 Oct;20(7):1074-81. doi: 10.1016/j.jse.2011.05.026.

Reference Type: BACKGROUND

PMID: 21925353 (View on PubMed)

Related Links

http://p3.snf.ch/project-135061

Lay summary in French language on the sponsor's website (Swiss National Science Foundation)

Other Identifiers

FNS-DORE 13DPD6_135061

Identifier Type: -

Identifier Source: org_study_id