- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06671366
Test-retest Correlation in Isokinetic Shoulder Testing (ISO2024)
Evaluation of Test-retest Correlation in Isokinetic Shoulder Testing
This study is a prospective, monocentric interventional clinical study in 30 healthy volunteers.
The aim is to objectively assess shoulder external and internal rotation strength using a Cybex dynamometer in a specific position (seated with the arm at 45° abduction and 30° elevation).
The investigator would like here to determine the reproducibility of measurements in this precise evaluation position, but also to determine reference values in healthy subjects.
The results of this study will enable us to improve our management and establish a database for comparison with pathological subjects.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Saint Jean de Vedas, France, 34430
- Clinique St jean sud de france
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Student of the Montpellier School of Physical Therapy
- Adult having received informed information about the study and signed the consent form
Exclusion Criteria:
- Any history of shoulder pathology in the year preceding the tests.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: External and internal shoulder rotation force
shoulder external and internal rotation force objectively using a Cybex dynamometer in a specific position (seated with the arm at 45° abduction and 30° elevation)
|
Measurement of the reproducibility, in this precise evaluation position, of the results obtained between the different tests carried out 30 minutes apart, and thus the reliability of each measurement in this test. measures :
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation between each measurement at peak torque
Time Frame: 1hour
|
Correlation between each measurement at peak torque below, and for each arm (12 correlations) in seated position abduction at 45 and 30 degrees anterior elevation.
Evaluation of results using an intraclass correlation coefficient (ICC). |
1hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Data in healthy patients
Time Frame: 1hour
|
Evaluation of the peak torque of each measurement in healthy patients, have a database.
|
1hour
|
|
Establishing the test's external validity
Time Frame: 1hour
|
Validated external test : 1) External validity
|
1hour
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2024-A01269-38 (Other Identifier: ANSM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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