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Core Stability Measures as a Risk Factor for the Development of Lower Extremity Injuries in Physical Education Students

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ClinicalTrials.gov Identifier: NCT03343379
Recruitment Status : Completed
First Posted : November 17, 2017
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
University Ghent

Tracking Information
First Submitted Date  ICMJE November 10, 2017
First Posted Date  ICMJE November 17, 2017
Last Update Posted Date November 17, 2017
Actual Study Start Date  ICMJE September 1, 2014
Actual Primary Completion Date December 31, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 10, 2017)
  • Core muscle strength [ Time Frame: 2 hours ]
    Isometric strength of trunk flexor and trunk extensor musculature measured in Newton
  • Hip strength [ Time Frame: 2 hours ]
    Isometric strength of hip flexor, hip extensor, hip abductor, hip adductor and hip rotator muscles measured in Newton
  • Postural control [ Time Frame: 2 hours ]
    Anterior, posterolateral and posteromedial reaching distance during unipodal stance, measured in cm
  • Core muscle endurance [ Time Frame: 2 hours ]
    Endurance capacity of ventral, dorsal and lateral core musculature, measured in seconds
  • Sensorimotor control of core musculature [ Time Frame: 2 hours ]
    Propriocention and neuromuscular control of the lumbopelvic muscles using a qualitative assessment sheet
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2017)
Injury history [ Time Frame: 2 hours ]
Previous lower extremity injuries, recorded using a questionnaire
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 Core Stability Measures as a Risk Factor for the Development of Lower Extremity Injuries in Physical Education Students
Official Title  ICMJE Core Stability as a Risk Factor for the Development of Lower Extremity Injuries: a Prospective Study
Brief Summary Male and female physical education students were subjected to a clinical test battery comprised of valid and reliable tests to measure different aspects of core stability at the start of the study. After a period of 2 months testing, the injury registration procedure started with the use of an online injury registration platform and regular call back moments. After 2 years of injury registration, all data was gathered and will be analysed statistically to link the measured core stability aspects as risk factors for certain lower extremity injuries.
Detailed Description

September 2014 - December 2014: 139 male and female participants 18+ were subjected to different test to evaluate corresponding aspects of core stability. The following test were performed: Star excursion balance test; Lumbopelvic proprioception test; Lumbopelvic neuromuscular control test; Lateral step down test; Hip strength test measured with a handheld dynamometer(flexion/extension/abduction/adduction/internal rotation/external rotation); Trunk strength tests measured with a handheld dynamometer (trunk flexion and trunk extension) and core muscle endurance tests (prone bridging test/Biering-Sorenson test/side bridging tests).

January 2015 - April 2017: Prospective follow up of lower extremity injury contracted during sports activity. The injuries were confirmed by a medical examiner and were recorded in an online injury registry platform (Survey Monkey).

Statistical analysis will be performed to evaluate which core stability outcome measure can be considered a risk factor for the development of lower extremity injuries.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
1 group of participants was screened at the start of the study and followed prospectively for 2 years
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Leg Injuries
Intervention  ICMJE Other: Core stability tests
A test battery comprised of field tests to evaluate core stability
Study Arms  ICMJE Healthy cohort
Core stability test
Intervention: Other: Core stability tests
Publications *

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: November 10, 2017)
139
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 1, 2017
Actual Primary Completion Date December 31, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

- 1st year of physical education study (enrolled at the Artevelde graduate school or the Ghent graduate school

Exclusion Criteria:

  • Musculoskeletal injury at the time of study participation
  • Pre-existing lower back injury
  • Pre-existing lower extremity injury (less than 6 months prior to study participation)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03343379
Other Study ID Numbers  ICMJE 2014/0780
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No individual participant data will be shared after completion of the study
Responsible Party University Ghent
Study Sponsor  ICMJE University Ghent
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Philip Roosen, PT, PhD University Ghent
PRS Account University Ghent
Verification Date November 2017

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