NCT01281085

Brief Summary

Questionnaires are frequently used to evaluate shoulder function in various diseases or after surgery. However, measurement of shoulder function is presently a controversial issue. Shoulder movement analysis based on embedded sensors could be a promising alternative to questionnaires. Some studies already demonstrated the relevance of this approach. It has also been demonstrated that a simple testing procedure including only two arm movements produces comparable results to more complicated testing procedures. However, more studies are needed to extensively establish if this simplified testing procedure provides a trustworthy evaluation of patient shoulder function and its evolution. This study is a preliminary study which aims to develop a precise testing procedure which will be used in a future study aiming to evaluate measurement properties of a simple shoulder function test based on movement sensors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 21, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

April 14, 2011

Status Verified

April 1, 2011

Enrollment Period

6 months

First QC Date

January 20, 2011

Last Update Submit

April 13, 2011

Conditions

Keywords

ShoulderOutcome treatmentValidation StudiesBiomechanics

Outcome Measures

Primary Outcomes (1)

  • variability of kinematic simplified functional score

    This pilot study mainly aims at defining how many tests replications are needed to obtain a reliable shoulder function measurement

    only one measurement session

Secondary Outcomes (1)

  • intra- and inter-reproducibility of kinematic functional shoulder score

    only one measurement session

Study Arms (1)

No treatment

Shoulder conditions including rotator cuff condition treated conservatively, shoulder instability treated conservatively, diaphyseal humerus fracture or subcapital humerus fracture treated surgically and frozen shoulder

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with a shoudler condition, as stated during the medical examination performed at the specialized shoulder consultation of the hospital

You may qualify if:

  • Rotator cuff condition, conservative treatment indicated
  • Shoulder instability, conservative treatment indicated
  • Diaphyseal humerus fracture or subcapital humerus fracture treated surgically, at 6 weeks post surgery
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Département de l'Appareil Locomoteur - CHUV

Lausanne, 1005, Switzerland

Location

Related Publications (1)

  • 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: 16934979BACKGROUND

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Claude A. Pichonnaz, PT MSc

    HECVSanté and CHUV-UNIL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 20, 2011

First Posted

January 21, 2011

Study Start

October 1, 2010

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

April 14, 2011

Record last verified: 2011-04

Locations