Leg InjuriesNCT03343379
Core Stability Measures as a Risk Factor for the Development of Lower Extremity Injuries in Physical Education Students
A study testing Core stability tests in people with Leg Injuries, run by University Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Leg Injuries
- What is being tested?
- Core stability tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2014to 1 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1st year of physical education study (enrolled at the Artevelde graduate school or the Ghent graduate school
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Vakgroep REVAKI (Ghent University - Ghent University hospital)
Ghent, 9000
About this study
Official title: Core Stability as a Risk Factor for the Development of Lower Extremity Injuries: a Prospective Study
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.
Read the 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.
- Conditions
- Leg Injuries
- Being tested
- Core stability tests
- Keywords
- Abdominal muscles, Back muscles, Core stability, Field test, Muscle strength dynamometer, Lower extremity injury, Risk assessment, Prospective studies
- Medical subject headings
- Leg Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core stability testsOther
A test battery comprised of field tests to evaluate core stability
| Study group | Role | What they receive |
|---|---|---|
| Healthy cohort | Other | Core stability test Receives: Other: Core stability tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core muscle strength
Isometric strength of trunk flexor and trunk extensor musculature measured in Newton
Measured: 2 hours
Hip strength
Isometric strength of hip flexor, hip extensor, hip abductor, hip adductor and hip rotator muscles measured in Newton
Measured: 2 hours
Postural control
Anterior, posterolateral and posteromedial reaching distance during unipodal stance, measured in cm
Measured: 2 hours
Core muscle endurance
Endurance capacity of ventral, dorsal and lateral core musculature, measured in seconds
Measured: 2 hours
Sensorimotor control of core musculature
Propriocention and neuromuscular control of the lumbopelvic muscles using a qualitative assessment sheet
Measured: 2 hours
Secondary outcomes (1)
Injury history
Previous lower extremity injuries, recorded using a questionnaire
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Sep 2014
- Primary completion31 Dec 2015
- Study completion1 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Leg InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 1 group of participants was screened at the start of the study and followed prospectively for 2 years
- Masking
- None (open label)
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philip Roosen, PT, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03343379
- Sponsor's protocol ID
- 2014/0780
- Status last verified
- Nov 2017
- First submitted
- 10 Nov 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No individual participant data will be shared after completion of the study
Publications
De Blaiser C, De Ridder R, Willems T, Danneels L, Vanden Bossche L, Palmans T, Roosen P. Evaluating abdominal core muscle fatigue: Assessment of the validity and reliability of the prone bridging test. Scand J Med Sci Sports. 2018 Feb;28(2):391-399. doi: 10.1111/sms.12919. Epub 2017 Jun 28.
PubMed 28544083De Blaiser C, Roosen P, Willems T, Danneels L, Bossche LV, De Ridder R. Is core stability a risk factor for lower extremity injuries in an athletic population? A systematic review. Phys Ther Sport. 2018 Mar;30:48-56. doi: 10.1016/j.ptsp.2017.08.076. Epub 2017 Aug 24.
PubMed 29246794Kibler WB, Press J, Sciascia A. The role of core stability in athletic function. Sports Med. 2006;36(3):189-98. doi: 10.2165/00007256-200636030-00001.
PubMed 16526831Willson JD, Dougherty CP, Ireland ML, Davis IM. Core stability and its relationship to lower extremity function and injury. J Am Acad Orthop Surg. 2005 Sep;13(5):316-25. doi: 10.5435/00124635-200509000-00005.
PubMed 16148357
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Core Stability as a Risk Factor for the Development of Lower Extremity Injuries: a Prospective Study
- ClinicalTrials.gov ID
- NCT03343379
- Acronym / sponsor ID
- 2014/0780
- Conditions
- Leg Injuries
- Keywords
- Abdominal muscles, Back muscles, Core stability, Field test, Muscle strength dynamometer, Lower extremity injury, Risk assessment, Prospective studies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 1 Apr 2017 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 1 group of participants was screened at the start of the study and followed prospectively for 2 years
| Arm | Type | Receives |
|---|---|---|
| Healthy cohort | Other | Other: Core stability testsCore stability test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1st year of physical education study (enrolled at the Artevelde graduate school or the Ghent graduate school
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Core stability testsA test battery comprised of field tests to evaluate core stability | Other | Healthy cohort |
Primary outcome
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
1 secondary outcome
Injury history
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Background: PubMed 28544083De Blaiser C, De Ridder R, Willems T, Danneels L, Vanden Bossche L, Palmans T, Roosen P. Evaluating abdominal core muscle fatigue: Assessment of the validity and reliability of the prone bridging test. Scand J Med Sci Sports. 2018 Feb;28(2):391-399. doi: 10.1111/sms.12919. Epub 2017 Jun 28.
- Background: PubMed 29246794De Blaiser C, Roosen P, Willems T, Danneels L, Bossche LV, De Ridder R. Is core stability a risk factor for lower extremity injuries in an athletic population? A systematic review. Phys Ther Sport. 2018 Mar;30:48-56. doi: 10.1016/j.ptsp.2017.08.076. Epub 2017 Aug 24.
- Background: PubMed 16526831Kibler WB, Press J, Sciascia A. The role of core stability in athletic function. Sports Med. 2006;36(3):189-98. doi: 10.2165/00007256-200636030-00001.
- Background: PubMed 16148357Willson JD, Dougherty CP, Ireland ML, Davis IM. Core stability and its relationship to lower extremity function and injury. J Am Acad Orthop Surg. 2005 Sep;13(5):316-25. doi: 10.5435/00124635-200509000-00005.
- Individual participant dataSharing planned: No. No individual participant data will be shared after completion of the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Roosen, PT, PhD principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core stability tests in people with Leg Injuries, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Core muscle strength (time frame: 2 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03343379, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017; AzTrials last refreshed its copy on 27 Oct 2026.