Validation of a Kinematic Functional Shoulder Score Including Only Essential Movements

NCT01431417 | Completed

• 1 other identifier: FNS-DORE 13DPD6_135061
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Shoulder; Outcome treatment; Validation Studies as topic; Biomechanics; Shoulder, Joint Instability

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (2)

• Functional scores as determined by several currently used shoulder scores

  Baseline

• Changes in functional shoulder scores

  Change from Baseline in functional shoulder scores at 6 months

Study Arms (5)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Haute Ecole de Santé Vaud: lead
• Swiss National Science Foundation: collaborator

Study Sites (1)

Département de l'Appareil Locomoteur - CHUV

Lausanne, 1005, Switzerland

Location

Related 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. doi: 10.1016/j.gaitpost.2006.06.016. Epub 2006 Aug 28.

  PMID: 16934979 BACKGROUND

• 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.

  PMID: 21925353 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Syndrome; Bursitis; Humeral Fractures; Joint Instability

Condition Hierarchy (Ancestors)

Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Joint Diseases; Musculoskeletal Diseases; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Claude A. Pichonnaz, PT MSc

  HESAV and University Hospital of Lausanne

  STUDY DIRECTOR

• Farron Alain, MER PD

  University of Lausanne Hospitals

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2011
• First Posted: September 9, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: May 1, 2014
• Last Updated: June 4, 2015

Record last verified: 2015-06

Locations

CH (1)