Validation of a Kinematic Functional Shoulder Score Including Only Essential Movements

This study has been completed.
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: August 20, 2014
Last verified: August 2014
  Purpose

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.


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

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 (Western Ontario Shoulder Instability Index; 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


Enrollment: 108
Study Start Date: July 2011
Study Completion Date: May 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

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

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: NCT01431417

Locations
Switzerland
Département de l'Appareil Locomoteur - CHUV
Lausanne, Switzerland, 1005
Sponsors and Collaborators
Haute Ecole Cantonale Vaudoise de Santé
Swiss National Science Foundation
Investigators
Study Director: Claude A. Pichonnaz, PT MSc HESAV and University Hospital of Lausanne
Study Chair: Farron Alain, MER PD University of Lausanne Hospitals
  More Information

Additional Information:
Publications:
Responsible Party: Haute Ecole Cantonale Vaudoise de Santé
ClinicalTrials.gov Identifier: NCT01431417     History of Changes
Other Study ID Numbers: FNS-DORE 13DPD6_135061
Study First Received: September 6, 2011
Last Updated: August 20, 2014
Health Authority: Switzerland: Ethikkommission

Keywords provided by Haute Ecole Cantonale Vaudoise de Santé:
Shoulder
Outcome treatment
Validation Studies as topic
Biomechanics
Shoulder, Joint Instability

Additional relevant MeSH terms:
Joint Instability
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on October 19, 2014