NCT06671366

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 4, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

November 8, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2025

Completed
Last Updated

June 15, 2025

Status Verified

September 1, 2024

Enrollment Period

3 months

First QC Date

October 30, 2024

Last Update Submit

June 11, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Correlation between each measurement at peak torque

    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. * Concentric internal rotation 60degrees/sec * Concentric external rotation 60 degrees/sec * Concentric internal rotation 180 degrees/sec * Concentric external rotation 180 degrees/sec * Eccentric internal rotation 60degrees/sec * Eccentric external rotation 60degrees/sec Evaluation of results using an intraclass correlation coefficient (ICC).

    1hour

Secondary Outcomes (2)

  • Data in healthy patients

    1hour

  • Establishing the test's external validity

    1hour

Study Arms (1)

External and internal shoulder rotation force

EXPERIMENTAL

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)

Device: external and internal shoulder rotation using a Cybex dynamometer

Interventions

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 : * Concentric internal rotation 60degrees/sec * Concentric external rotation 60 degrees/sec * Concentric internal rotation 180 degrees/sec * Concentric external rotation 180 degrees/sec * Eccentric internal rotation 60degrees/sec * Eccentric external rotation 60degrees/sec

External and internal shoulder rotation force

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Student of the Montpellier School of Physical Therapy
  • Adult having received informed information about the study and signed the consent form

You may not qualify if:

  • Any history of shoulder pathology in the year preceding the tests.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique St Jean Sud de France

Saint-Jean-de-Védas, 34430, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2024

First Posted

November 4, 2024

Study Start

November 8, 2024

Primary Completion

January 29, 2025

Study Completion

January 29, 2025

Last Updated

June 15, 2025

Record last verified: 2024-09

Locations