Rotator Cuff, SyndromeNCT01431417
Validation of a Kinematic Functional Shoulder Score Including Only Essential Movements
An observational study of Rotator Cuff, Syndrome and Frozen Shoulder, run by Haute Ecole de Santé Vaud at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff, Syndrome, Frozen Shoulder, Humerus, Fracture
- How many people
- 108 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2011to May 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients consulting at the specialized shoulder consultation of the University Hospital of Lausanne
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Département de l'Appareil Locomoteur - CHUV
Lausanne, 1005
About this study
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.
Read more
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.
Read the 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.
- 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
- Medical subject headings
- Syndrome, Bursitis, Humeral Fractures, Joint Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline
Changes in kinematic functional shoulder scores
Aforementioned score will be measured again 6 months after baseline to evaluate its responsiveness to patients' evolution
Measured: Change from Baseline in kinematic functional shoulder scores at 6 months
Secondary outcomes (2)
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
Measured: Baseline
Changes in functional shoulder scores
All aforementioned scores will be measured again 6 months after baseline to compare their respective responsiveness to patients' evolution
Measured: Change from Baseline in functional shoulder scores at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff, SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haute Ecole de Santé Vaud
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation
- Responsible party
- Sponsor
- Investigators
- Claude A. Pichonnaz, PT MSc, Study director, HESAV and University Hospital of LausanneFarron Alain, MER PD, Study chair, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01431417
- Sponsor's protocol ID
- FNS-DORE 13DPD6_135061
- Status last verified
- Jun 2015
- First submitted
- 6 Sep 2011
- Last updated
- 4 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16934979Jolles 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.
PubMed 21925353
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Kinematic Functional Shoulder Score Including Only Essential Movements
- ClinicalTrials.gov ID
- NCT01431417
- Acronym / sponsor ID
- FNS-DORE 13DPD6_135061
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Haute Ecole de Santé VaudUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation
- Study start
- Aug 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 9 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients consulting at the specialized shoulder consultation of the University Hospital of Lausanne
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Kinematic functional score
Time frame: Baseline
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
Aforementioned score will be measured again 6 months after baseline to evaluate its responsiveness to patients' evolution
2 secondary outcomes
Functional scores as determined by several currently used shoulder scores
Time frame: Baseline
Changes in functional shoulder scores
Time frame: Change from Baseline in functional shoulder scores at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2015.
- Background: PubMed 16934979Coley 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.
- Background: PubMed 21925353Jolles 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.
Related trials for Rotator Cuff, Syndrome
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Not yet recruiting
Spencer vs Positional Release Techniques for Chronic Subacromial Impingement
Chronic Subacromial Impingement Syndrome
RecruitingObservational study
Night Pain Module for Rotator Cuff-Related Shoulder Pain
Shoulder Pain, Rotator Cuff Related Shoulder Pain
Recruiting
Comparison of Surgery With Prehabilitation, Direct Surgery and Rehabilitation for Patients With Femoroacetabular Impingement
Femoroacetabular Impingement Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claude A. Pichonnaz, PT MSc study director
HESAV and University Hospital of Lausanne
Farron Alain, MER PD study chair
University of Lausanne Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff, Syndrome and Frozen Shoulder, run by Haute Ecole de Santé Vaud at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinematic functional score (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01431417, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2015.