Validation of a Kinematic Functional Shoulder Score Including Only Essential Movements

Frozen Shoulder Clinical Trial

Official title:

Validation of a Kinematic Functional Shoulder Score Including Only Essential Movements

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01431417
• Other study ID #: FNS-DORE 13DPD6_135061
• Status: Completed
• Phase: N/A
• First received: September 6, 2011
• Last updated: June 2, 2015
• Start date: August 2011
• Est. completion date: May 2014

Study information

• Verified date: June 2015
• Source: Haute Ecole Cantonale Vaudoise de Santé
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: May 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Switzerland	Département de l'Appareil Locomoteur - CHUV	Lausanne

Sponsors (2)

Lead Sponsor	Collaborator
Haute Ecole Cantonale Vaudoise de Santé	Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

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. Epub 2006 Aug 28. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kinematic functional score	The kinematic functional score will be determined as the percentage of power of the pathological shoulder compared to the healthy shoulder (e.g. 70% means that the power developed during the movement of the pathological shoulder reaches 70% of the power developed on the healthy side)	Baseline	No
Primary	Changes in kinematic functional shoulder scores	Aforementioned score will be measured again 6 months after baseline to evaluate its responsiveness to patients' evolution	Change from Baseline in kinematic functional shoulder scores at 6 months	No
Secondary	Functional scores as determined by several currently used shoulder scores	Questionnaires include Constant score, Quick DASH, subjective shoulder value, Simple shoulder test, WOSI (Western Ontario Shoulder Instability Index; when relevant i.e. for shoulder instability), stiffness and pain EVA	Baseline	No
Secondary	Changes in functional shoulder scores	All aforementioned scores will be measured again 6 months after baseline to compare their respective responsiveness to patients' evolution	Change from Baseline in functional shoulder scores at 6 months	No

External Links

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