NCT05291273

Brief Summary

A previous study of the Closed Kinetic Chain Upper Extremity Stability Test (EPOLTEST) in a population aged 18 to 25 years isolated 3 main factors influencing the CKCUEST score: upper extremity span, weight, and sex of the individual. A predictive equation for the CKCUEST score was thus established and to date has a capacity to determine the real score of approximately 51%. The results of this first study show that a certain number of variables have not been studied. The purpose of this study, EPOLTEST 2, is to take into account the variables already studied on a larger population (18-50 years old) and to add an assessment of shoulder muscle strength and abdominolumbar endurance.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
247

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

March 11, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 22, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

June 8, 2022

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2025

Completed
Last Updated

February 6, 2025

Status Verified

February 1, 2025

Enrollment Period

3.5 years

First QC Date

March 11, 2022

Last Update Submit

February 4, 2025

Conditions

Keywords

CKCUESTPhysical activityRehabilitation

Outcome Measures

Primary Outcomes (10)

  • Closed Kinetic Chain Upper Extremity Stability Test (CKCUEST) score

    Closed Kinetic Chain Upper Extremity Stability Test/ The CKCUEST is a functional test which assess shoulder's stability. Patient is in push-up position, with 91 cm between his hands. His body is straight and his foots are squeeze. Patient has to touch his hand with his other one and returns in the initial position. Then, patient repeats this movement with his other hand, etc, during 15 secondes. The CKCUEST score is the movement's number performed. Three tests are performed. The outcome measure will be the mean of the score of the three tests realisation.

    Day 1

  • Anthropometric data

    Measurement of the subject's weight in kilograms

    Day 1

  • Anthropometric data

    Measurement of the subject's height in centimeters

    Day 1

  • Anthropometric data

    Measurement of the subject's BMI in kg/m\^2

    Day 1

  • Anthropometric data

    Measurement of the subject's upper extremity length in centimeters

    Day 1

  • Anthropometric data

    Measurement of the subject's upper extremity span in centimeters

    Day 1

  • Anthropometric data

    Measurement of the subject's distance between acromion and radial styloid of the right upper limb in centimeters

    Day 1

  • Anthropometric data

    Measurement of the subject's distance between olecranon and radial styloid of the right upper limb in centimeters

    Day 1

  • Muscular strength of the shoulder complex

    Maximum isometric force of the external and internal rotators and abductors/adductors measured by a dynamometer in Newton.

    Day 1

  • Abdominal-lumbar stability

    The prone bridge test also known as the "plank" or "hover" measures the muscular endurance of the abdominal muscles. Subjects will start in the "down" push up position with their feet together and their hands shoulder width apart. When the test starts the subject will push up to the prone bridge position so they are resting on their hands and toes making sure they maintain a straight line from the shoulders through the hips to the knees. The outcome measure will be the time where the subject stay in this position.

    Day 1

Study Arms (1)

Intervention

EXPERIMENTAL

All subjects will perform the same tests.

Diagnostic Test: Closed Kinetic Chain Upper Extremity Stability TestDiagnostic Test: Prone Bridge TestDiagnostic Test: Measurement of the muscle strength of the shoulder complex

Interventions

Each patient receive the same intervention, the Closed Kinetic Chain Upper Extremity Stability Test (CKCUEST). The CKCUEST is a functional test which assess shoulder's stability. Patient is in push-up position, with 91 cm between his hands. His body is straight and his foots are squeeze. patient has to touch his hand with his other one and returns in the initial position. Then, patient repeats this movement with his other hand, etc, during 15 secondes. The CKCUEST score is the movement's number performed.

Intervention
Prone Bridge TestDIAGNOSTIC_TEST

The prone bridge test also known as the "plank" or "hover" measures the muscular endurance of the abdominal muscles. Subjects will start in the "down" push up position with their feet together and their hands shoulder width apart. When the test starts the subject will push up to the prone bridge position so they are resting on their hands and toes making sure they maintain a straight line from the shoulders through the hips to the knees. The outcome measure will be the time where the subject stay in this position.

Intervention

Maximum isometric force of the external and internal rotators and abductors/adductors measured by a dynamometer.

Intervention

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged to 18 to 50 years
  • Capacity to consent
  • Who has signed the consent

You may not qualify if:

  • Fracture history or upper limb luxation \< 1 year
  • Pain or discomfort that prevents the test from being performed
  • History of abdominal surgery or hernia \< 1 year
  • Pregnant or nursing
  • Refuse to participate
  • Guardianship or protection of vulnerable adult

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Brest

Brest, 29200, France

RECRUITING

MeSH Terms

Conditions

Shoulder PainMotor Activity

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: This study is a monocentric interventional prospective study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2022

First Posted

March 22, 2022

Study Start

June 8, 2022

Primary Completion

December 8, 2025

Study Completion

December 8, 2025

Last Updated

February 6, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

All collected data that underlie results in a publication

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available after the publication of result and ending fifteen years following the last visit of the last patient.
Access Criteria
Data access requests will be reviewed by the internal committee of Brest University Hospital. Requestors will be required to sign and complete a data access agreement.

Locations