ACL InjuryPhase 2NCT01591941
Effectiveness of a Novel Warm-up in Decreasing Risk Factors for ACL Injury in Female Youth Soccer Players
A Phase 2 study testing Core-PAC in people with ACL Injury, run by University of British Columbia at 1 site in Canada.
Trial summary
There is a large number of young women who sustain serious knee injuries from playing soccer. Female athletes are at high risk of knee injuries from soccer than males. We will conduct a research project to assess the effect of a warm-up on changing some of the movement patterns thought to contribute to these serious… Read more about this study
- Who is it for?
- Ages 14 to 17 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- ACL Injury
- What is being tested?
- Core-PAC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2006to Aug 2007
- Phase
- Phase 2
- 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 14 to 17 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- 14-17 years of age;
- have no injuries for six weeks prior to testing;
- have no medical problems preventing them from participating in the study.
Who cannot join
- have a previous ACL injury or repair;
- have a back or lower limb injury that kept them from playing or training for greater than 30 days in the past year;
- presently using a supplemental exercise based program;
- have any medical or neurologic condition that would impair their ability to perform the tasks.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Rehab Research Lab, GF Strong Rehab Centre
Vancovuer, British Columbia, V5Z 2G9
About this study
Official title: The Effectiveness of a Novel Warm-up in Decreasing Risk Factors for Anterior Cruciate Ligament Injury in Female Youth Soccer Players
There is a large number of young women who sustain serious knee injuries from playing soccer. Female athletes are at high risk of knee injuries from soccer than males. We will conduct a research project to assess the effect of a warm-up on changing some of the movement patterns thought to contribute to these serious knee injuries.
It is hypothesized that a core position and control movement strategy (Core-PAC) group reduce biomechanical risk factors at the knee compared to a control after the training program.
Read the detailed description
There is a large number of young women who sustain serious knee injuries from playing soccer. Female athletes are at high risk of knee injuries from soccer than males. We will conduct a research project to assess the effect of a warm-up on changing some of the movement patterns thought to contribute to these serious knee injuries.
A core position and control movement strategy (Core-PAC) may be one method of modifying high-risk movements such as side-cutting. The Core-PAC is a simple method of getting the centre of mass (COM) closer to the plant foot or base of support (BOS). Moving the COM closer to the BOS may bias joint loading to the sagittal rather than the frontal and transverse planes, which often occurs in female athletes and poses a risk for ACL injury.
In this study, we will conduct a randomized controlled trial to compare a Core-PAC trained group to a control group for peak flexion angles and peak abduction moments at the knee during a side-cut and an unanticipated side-cut prior to kicking a soccer ball and a side-hop task after a six-week training program.
It is hypothesized that a Core-PAC group would have greater peak flexion angles and lower peak abduction moments at the knee compared to a control after the training program.
- Conditions
- ACL Injury
- Being tested
- Core-PAC
- Keywords
- ACL, Knee , Injury,
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core-PACOther
Core position and control movement strategy (Core-PAC):
Do warm-up prior to 6 weeks of regular soccer training for peak flexion angles and peak abduction moments at the knee during a side-cut (SC) and an unanticipated side-cut (USC) prior to kicking a soccer ball and a side-hop (SH) task.
| Study group | Role | What they receive |
|---|---|---|
| CON group | Active comparator | Control Group underwent a standard soccer warm-up Receives: Other: Core-PAC |
| Core-PAC | Experimental | Experimental took part in the Core position and control movement strategy (Core-PAC) warm-up Receives: Other: Core-PAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak knee flexion angle and peak abduction moment
Intervention group will be instructed to move from the trunk first during a series of athletic tasks. The Control group will be instructed to move with their usual athletic movements during the same tasks.
After 6 weeks of this training, subjects will be asked to return to the GF Strong Rehabilitation Center for biomechanical testing.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2012 (estimated)
- Study startJun 2006
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL InjuryStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suan R Harris, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01591941
- Sponsor's protocol ID
- BCM06-0007
- Status last verified
- May 2012
- First submitted
- 2 May 2012
- Last updated
- 7 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Novel Warm-up in Decreasing Risk Factors for Anterior Cruciate Ligament Injury in Female Youth Soccer Players
- ClinicalTrials.gov ID
- NCT01591941
- Acronym / sponsor ID
- BCM06-0007
- Conditions
- ACL Injury
- Keywords
- ACL, Knee , Injury,
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 4 May 2012 (estimated)
- 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.
There is a large number of young women who sustain serious knee injuries from playing soccer. Female athletes are at high risk of knee injuries from soccer than males. We will conduct a research project to assess the effect of a warm-up on changing some of the movement patterns thought to contribute to these serious knee injuries.
It is hypothesized that a core position and control movement strategy (Core-PAC) group reduce biomechanical risk factors at the knee compared to a control after the training program.
Detailed description
There is a large number of young women who sustain serious knee injuries from playing soccer. Female athletes are at high risk of knee injuries from soccer than males. We will conduct a research project to assess the effect of a warm-up on changing some of the movement patterns thought to contribute to these serious knee injuries.
A core position and control movement strategy (Core-PAC) may be one method of modifying high-risk movements such as side-cutting. The Core-PAC is a simple method of getting the centre of mass (COM) closer to the plant foot or base of support (BOS). Moving the COM closer to the BOS may bias joint loading to the sagittal rather than the frontal and transverse planes, which often occurs in female athletes and poses a risk for ACL injury.
In this study, we will conduct a randomized controlled trial to compare a Core-PAC trained group to a control group for peak flexion angles and peak abduction moments at the knee during a side-cut and an unanticipated side-cut prior to kicking a soccer ball and a side-hop task after a six-week training program.
It is hypothesized that a Core-PAC group would have greater peak flexion angles and lower peak abduction moments at the knee compared to a control after the training program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CON group | Active comparator | Other: Core-PACControl Group underwent a standard soccer warm-up |
| Core-PAC | Experimental | Other: Core-PACExperimental took part in the Core position and control movement strategy (Core-PAC) warm-up |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 14-17 years of age;
- have no injuries for six weeks prior to testing;
- have no medical problems preventing them from participating in the study.
Key exclusion criteria (4 listed)
- have a previous ACL injury or repair;
- have a back or lower limb injury that kept them from playing or training for greater than 30 days in the past year;
- presently using a supplemental exercise based program;
- have any medical or neurologic condition that would impair their ability to perform the tasks.
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-PACCore position and control movement strategy (Core-PAC): Do warm-up prior to 6 weeks of regular soccer training for peak flexion angles and peak abduction moments at the knee during a side-cut (SC) and an unanticipated side-cut (USC) prior to kicking a soccer ball and a side-hop (SH) task. | Other | CON group, Core-PAC |
Primary outcome
Peak knee flexion angle and peak abduction moment
Time frame: 6 weeks
Intervention group will be instructed to move from the trunk first during a series of athletic tasks. The Control group will be instructed to move with their usual athletic movements during the same tasks. After 6 weeks of this training, subjects will be asked to return to the GF Strong Rehabilitation Center for biomechanical testing.
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 7 May 2012.
Related trials for ACL Injury
Not yet recruiting
Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Recruiting
Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
Anterior Cruciate Ligament Injuries
Not yet recruiting
Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Not yet recruiting
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Recovery Quality in Patients Undergoing Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Injuries, Recovery Quality
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.
Suan R Harris, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Core-PAC in people with ACL Injury, run by University of British Columbia at 1 site in Canada.
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 3 inclusion and 4 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 7 May 2012. 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 Canada. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Peak knee flexion angle and peak abduction moment (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2012.