Validation of a Kinematic Functional Shoulder Score Including Only Essential Movements

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Swiss National Science Foundation
Information provided by (Responsible Party):
Haute Ecole Cantonale Vaudoise de Santé
ClinicalTrials.gov Identifier:
NCT01431417
First received: September 6, 2011
Last updated: March 4, 2014
Last verified: March 2014

September 6, 2011
March 4, 2014
July 2011
December 2013   (final data collection date for primary outcome measure)
  • Kinematic functional score [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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)
  • Changes in kinematic functional shoulder scores [ Time Frame: Change from Baseline in kinematic functional shoulder scores at 6 months ] [ Designated as safety issue: No ]
    Aforementioned score will be measured again 6 months after baseline to evaluate its responsiveness to patients' evolution
Kinematic functional score [ Time Frame: Baseline ] [ Designated as safety issue: No ]
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 developped during the movement of the pathological shoulder reaches 70% of the power developped on the healthy side)
Complete list of historical versions of study NCT01431417 on ClinicalTrials.gov Archive Site
  • Functional scores as determined by several currently used shoulder scores [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Questionnaires include Constant score, Quick DASH, subjective shoulder value, Simple shoulder test, WOSI (when relevant i.e. for shoulder instability), stiffness and pain EVA
  • Changes in functional shoulder scores [ Time Frame: Change from Baseline in functional shoulder scores at 6 months ] [ Designated as safety issue: No ]
    All aforementioned scores will be measured again 6 months after baseline to compare their respective responsiveness to patients' evolution
  • Functional scores as determined by several currently used shoulder scores [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Questionnaires include Constant score, Quick DASH, subjective shoulder value, Simple shoulder test, WOSI (when relevant i.e. for shoulder instability), stifness and pain EVA
  • Changes in functional shoulder scores [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    All aforementioned scores will be measured again 6 months after baseline to compare their respective responsiveness to patients' evolution
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Validation of a Kinematic Functional Shoulder Score Including Only Essential Movements
Validation of a Kinematic Functional Shoulder Score Including Only Essential Movements

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients consulting at the specialized shoulder consultation of the University Hospital of Lausanne

  • Rotator Cuff, Syndrome
  • Frozen Shoulder
  • Humerus, Fracture
  • Other Instability of Joint, Shoulder Region
Not Provided
  • Healthy volunteers
    Healthy volunteers, less than 35 years old and presenting with no shoulder condition
  • Patients with rotator cuff condition
    Patients with rotator cuff condition, conservative treatment indicated
  • Patients with shoulder instability
    Patients with shoulder instability, conservative treatment indicated
  • 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).
  • Patients with frozen shoulder
    Patients with frozen shoulder, conservative treatment indicated
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
108
April 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01431417
FNS-DORE 13DPD6_135061
No
Haute Ecole Cantonale Vaudoise de Santé
Haute Ecole Cantonale Vaudoise de Santé
Swiss National Science Foundation
Study Director: Claude A. Pichonnaz, PT MSc HESAV and University Hospital of Lausanne
Study Chair: Farron Alain, MER PD University of Lausanne Hospitals
Haute Ecole Cantonale Vaudoise de Santé
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP