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Impact of Anthropometrics Data and of Physical Activity Level in Closed kineTic Chain Upper Extremity Stability Test (EPOLTEST)

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ClinicalTrials.gov Identifier: NCT04090632
Recruitment Status : Recruiting
First Posted : September 16, 2019
Last Update Posted : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Tracking Information
First Submitted Date  ICMJE August 12, 2019
First Posted Date  ICMJE September 16, 2019
Last Update Posted Date November 15, 2019
Actual Study Start Date  ICMJE November 14, 2019
Estimated Primary Completion Date November 14, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2019)
Closed Kinetic Chain Upper Extremity Stability Test (CKCUEST) score [ Time Frame: Day 1 ]
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. The outcome measure will be the mean of the three test realisation.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04090632 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2019)
Global Physical Activity Questionnaire (GPAQ) [ Time Frame: Day 1 ]
Global Physical Activity Questionnaire. It is a standardized questionnaire which evaluate the global physical activity. GPAQ takes into account both number and intensity of activity. There are 4 parts (profession activities,day to day ways of moving, hobbies, sedentarity) in total being 16 questions.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Anthropometrics Data and of Physical Activity Level in Closed kineTic Chain Upper Extremity Stability Test
Official Title  ICMJE Impact of Anthropometrics Data and of Physical Activity Level in Closed kineTic Chain Upper Extremity Stability Test (CKCUEST) - EPOLTEST Study
Brief Summary The purpose of this study is to evaluate impact of anthropometric criteria to CKCUEST score.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
This study is a monocentric interventional prospective study
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Shoulder Pain
Intervention  ICMJE Diagnostic Test: Closed Kinetic Chain Upper Extremity Stability Test
Each patient receive the same intervention, the 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.
Study Arms  ICMJE Experimental: closed kineTic chain upper Extremity Stability Test
Each patient receive the same intervention, the 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: Diagnostic Test: Closed Kinetic Chain Upper Extremity Stability Test
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 13, 2019)
82
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 14, 2020
Estimated Primary Completion Date November 14, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged to 18 to 25 years
  • Capacity to consent
  • Who has signed the consent

Exclusion Criteria:

  • fracture history or upper limb luxation
  • is not possible to do the test because of pain
  • pregnant or nursing
  • refuse to participate
  • guardianship or protection of vulnerable adult
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 25 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Marc Beaumont +33 (0)2 98 62 61 60 mbeaumont@ch-morlaix.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04090632
Other Study ID Numbers  ICMJE 29BRC19.0147
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: All collected data that underlie results in a publication
Supporting Materials: 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.
Responsible Party University Hospital, Brest
Study Sponsor  ICMJE University Hospital, Brest
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital, Brest
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP