Anterior Cruciate Ligament InjuryNCT02530333
Differential Biomechanical Effects of an ACL Injury Prevention Program in Women's Basketball and Soccer Players
A study testing Neuromuscular Prevention Program in people with Anterior Cruciate Ligament Injury, run by High Point University at 1 site in United States.
Trial summary
Anterior cruciate ligament injury programs are less successful in women's basketball than soccer players, yet the reason for this discrepancy is unknown. Thus, this study will recruit high school aged girl's basketball and soccer players, randomized teams into control and experimental groups, administer an ACL injury… Read more about this study
- Who is it for?
- Ages 12 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament Injury
- What is being tested?
- Neuromuscular Prevention Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Nov 2015
- 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 12 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Participants will need to be participating in high school aged, competitive-level basketball and/or soccer and are medically cleared to participate in sports.
Who cannot join
- Participants will be excluded if they have a history of lower extremity surgery in the past 6 months, or have been diagnosed with a vestibular, balance, or cardiovascular disorders that may preclude safe participation during landing and jumping activities.
Trial locations and contacts
1 site in 1 country.
United States1 site
High Point University
High Point, North Carolina, 27268
About this study
Anterior cruciate ligament injury programs are less successful in women's basketball than soccer players, yet the reason for this discrepancy is unknown. Thus, this study will recruit high school aged girl's basketball and soccer players, randomized teams into control and experimental groups, administer an ACL injury prevention program in the experimental group and compare the two groups on their lower extremity biomechanics before and after completion of the program. Biomechanical analyses will help determine the extent to which women's basketball and soccer players respond differently to a uniform injury prevention program, and whether this prevention program provides an adequate stimulus to improve lower extremity biomechanics during basketball-specific tasks.
Read the detailed description
Anterior cruciate ligament (ACL) injury prevention programs are considerably less successful in women's basketball than women's soccer. Women's basketball and soccer are each characterized by distinct sport-specific demands, where women's basketball players perform significantly more frequent jumping (2- and 1-legged landings) and frontal plane movements than women's soccer players. Despite varying sport-specific demands, ACL injury prevention programs have been uniformly administered in both sports, and emphasize improving high-risk biomechanics during 2-legged sagittal plane tasks. As such, they may not provide the appropriate stimulus to reduce ACL injury risk during the high-risk demands associated with women's basketball. To date, the differential biomechanical adaptations that result from ACL injury prevention programs in women's basketball and soccer have never been investigated.
This study will use a cluster randomized controlled trial using a repeated measures design. Participants will be randomized (by team) in to control and intervention groups. Participants in the control group will be asked to continue their normal daily and athletic activities (practices, games) without participating any distinct injury prevention training. Participants in the intervention group will complete at 6 week ACL injury prevention program previously described in the literature as being effective at reducing ACL injury risk. The prevention program lasts 20-25 minutes in duration and will take place as a warm-up prior to any practice. The frequency will depend solely on the number of practices each team holds throughout the given 6-week time period. A member of the research team plans to be at each intervention session. All participants will complete pre- and post-testing approximately 1 week before the onset and after the completion of the prevention program, respectively. As stated previously, all pre- and post-testing will be performed at the High Point University Human Biomechanics and Physiology Laboratory.
The following are Specific Aims and Hypotheses. Specific Aim 1. To determine the extent to which women's basketball and soccer players employ distinct lower extremity movement strategies during sagittal and frontal plane jump landing tasks.
Hypothesis 1. Prior to training, women's basketball athletes will exhibit no significant differences in high-risk hip and knee kinematics, but will generate higher hip and knee joint moments during jump landing activities than women's soccer players.
Specific Aim 2. To determine the response of women's basketball and soccer athletes to a 6-week ACL injury prevention program, as measured by changes in multi-planar hip and knee biomechanics of jump landings during sagittal and frontal plane jump landing tasks.
Hypothesis 1. After 6 weeks of training, high-risk biomechanics will improve to a larger extent during sagittal plane than frontal plane jump landing tasks.
Hypothesis 2. After 6 weeks of training, there will be no significant differences in biomechanical changes in women's basketball compared to women's soccer players.
- Conditions
- Anterior Cruciate Ligament Injury
- Being tested
- Neuromuscular Prevention Program
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular Prevention ProgramOther
Participants in the intervention group will complete at 6 week ACL injury prevention program previously described in the literature as being effective at reducing ACL injury risk. The prevention program lasts 20-25 minutes in duration and will take place as a warm-up prior to any practice. The frequency will depend solely on the number of practices each team holds throughout the given 6-week time period.
| Study group | Role | What they receive |
|---|---|---|
| Basketball Control | No intervention | Control group of basketball players |
| Basketball intervention | Experimental | Intervention group of basketball players Receives: Other: Neuromuscular Prevention Program |
| Soccer Control | No intervention | Control group of soccer players |
| Soccer Intervention | Experimental | intervention group of soccer players Receives: Other: Neuromuscular Prevention Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower Extremity Angular Kinematics (hip flexion, hip adduction, hip internal rotation, knee flexion, abduction, knee internal rotation, knee external rotation)
Measured: 6-8 weeks
Lower Extremity Kinetics (hip flexion, hip adduction, hip internal rotation, knee flexion, abduction, knee internal rotation, knee external rotation external moments)
Measured: 6-8 weeks
Secondary outcomes (3)
Triple Jump Distance
Measured: 6-8 weeks
Maximal Vertical Jump Height
Countermovement jump
Measured: 6-8 weeks
Agility
T-test
Measured: 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2015 (estimated)
- Study startMay 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuryStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- High Point University
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Greensboro
- Responsible party
- Sponsor
- Investigators
- Jeffrey B Taylor, DPT, Principal investigator, High Point University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02530333
- Sponsor's protocol ID
- 201404-370
- Status last verified
- Jan 2016
- First submitted
- 21 May 2015
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Taylor JB, Nguyen AD, Shultz SJ, Ford KR. Hip biomechanics differ in responders and non-responders to an ACL injury prevention program. Knee Surg Sports Traumatol Arthrosc. 2020 Apr;28(4):1236-1245. doi: 10.1007/s00167-018-5158-1. Epub 2018 Sep 27.
PubMed 30259145Taylor JB, Ford KR, Schmitz RJ, Ross SE, Ackerman TA, Shultz SJ. Sport-specific biomechanical responses to an ACL injury prevention programme: A randomised controlled trial. J Sports Sci. 2018 Nov;36(21):2492-2501. doi: 10.1080/02640414.2018.1465723. Epub 2018 Apr 19.
PubMed 29671383
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Biomechanical Effects of an ACL Injury Prevention Program in Women's Basketball and Soccer Players
- ClinicalTrials.gov ID
- NCT02530333
- Acronym / sponsor ID
- 201404-370
- Conditions
- Anterior Cruciate Ligament Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- High Point UniversityUniversity, hospital or other
- Collaborators
- University of North Carolina, Greensboro
- Study start
- May 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 21 Aug 2015 (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.
Anterior cruciate ligament injury programs are less successful in women's basketball than soccer players, yet the reason for this discrepancy is unknown. Thus, this study will recruit high school aged girl's basketball and soccer players, randomized teams into control and experimental groups, administer an ACL injury prevention program in the experimental group and compare the two groups on their lower extremity biomechanics before and after completion of the program. Biomechanical analyses will help determine the extent to which women's basketball and soccer players respond differently to a uniform injury prevention program, and whether this prevention program provides an adequate stimulus to improve lower extremity biomechanics during basketball-specific tasks.
Detailed description
Anterior cruciate ligament (ACL) injury prevention programs are considerably less successful in women's basketball than women's soccer. Women's basketball and soccer are each characterized by distinct sport-specific demands, where women's basketball players perform significantly more frequent jumping (2- and 1-legged landings) and frontal plane movements than women's soccer players. Despite varying sport-specific demands, ACL injury prevention programs have been uniformly administered in both sports, and emphasize improving high-risk biomechanics during 2-legged sagittal plane tasks. As such, they may not provide the appropriate stimulus to reduce ACL injury risk during the high-risk demands associated with women's basketball. To date, the differential biomechanical adaptations that result from ACL injury prevention programs in women's basketball and soccer have never been investigated.
This study will use a cluster randomized controlled trial using a repeated measures design. Participants will be randomized (by team) in to control and intervention groups. Participants in the control group will be asked to continue their normal daily and athletic activities (practices, games) without participating any distinct injury prevention training. Participants in the intervention group will complete at 6 week ACL injury prevention program previously described in the literature as being effective at reducing ACL injury risk. The prevention program lasts 20-25 minutes in duration and will take place as a warm-up prior to any practice. The frequency will depend solely on the number of practices each team holds throughout the given 6-week time period. A member of the research team plans to be at each intervention session. All participants will complete pre- and post-testing approximately 1 week before the onset and after the completion of the prevention program, respectively. As stated previously, all pre- and post-testing will be performed at the High Point University Human Biomechanics and Physiology Laboratory.
The following are Specific Aims and Hypotheses. Specific Aim 1. To determine the extent to which women's basketball and soccer players employ distinct lower extremity movement strategies during sagittal and frontal plane jump landing tasks.
Hypothesis 1. Prior to training, women's basketball athletes will exhibit no significant differences in high-risk hip and knee kinematics, but will generate higher hip and knee joint moments during jump landing activities than women's soccer players.
Specific Aim 2. To determine the response of women's basketball and soccer athletes to a 6-week ACL injury prevention program, as measured by changes in multi-planar hip and knee biomechanics of jump landings during sagittal and frontal plane jump landing tasks.
Hypothesis 1. After 6 weeks of training, high-risk biomechanics will improve to a larger extent during sagittal plane than frontal plane jump landing tasks.
Hypothesis 2. After 6 weeks of training, there will be no significant differences in biomechanical changes in women's basketball compared to women's soccer players.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Basketball Control | No intervention | –Control group of basketball players |
| Basketball intervention | Experimental | Other: Neuromuscular Prevention ProgramIntervention group of basketball players |
| Soccer Control | No intervention | –Control group of soccer players |
| Soccer Intervention | Experimental | Other: Neuromuscular Prevention Programintervention group of soccer players |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Participants will need to be participating in high school aged, competitive-level basketball and/or soccer and are medically cleared to participate in sports.
Key exclusion criteria (1 listed)
- Participants will be excluded if they have a history of lower extremity surgery in the past 6 months, or have been diagnosed with a vestibular, balance, or cardiovascular disorders that may preclude safe participation during landing and jumping activities.
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 |
|---|---|---|
| Neuromuscular Prevention ProgramParticipants in the intervention group will complete at 6 week ACL injury prevention program previously described in the literature as being effective at reducing ACL injury risk. The prevention program lasts 20-25 minutes in duration and will take place as a warm-up prior to any practice. The frequency will depend solely on the number of practices each team holds throughout the given 6-week time period. | Other | Basketball intervention, Soccer Intervention |
Primary outcome
Lower Extremity Angular Kinematics (hip flexion, hip adduction, hip internal rotation, knee flexion, abduction, knee internal rotation, knee external rotation)
Time frame: 6-8 weeks
Lower Extremity Kinetics (hip flexion, hip adduction, hip internal rotation, knee flexion, abduction, knee internal rotation, knee external rotation external moments)
Time frame: 6-8 weeks
3 secondary outcomes
Triple Jump Distance
Time frame: 6-8 weeks
Maximal Vertical Jump Height
Time frame: 6-8 weeks
Agility
Time frame: 6-8 weeks
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 8 Jan 2016.
- Derived from this study: PubMed 30259145Taylor JB, Nguyen AD, Shultz SJ, Ford KR. Hip biomechanics differ in responders and non-responders to an ACL injury prevention program. Knee Surg Sports Traumatol Arthrosc. 2020 Apr;28(4):1236-1245. doi: 10.1007/s00167-018-5158-1. Epub 2018 Sep 27.
- Derived from this study: PubMed 29671383Taylor JB, Ford KR, Schmitz RJ, Ross SE, Ackerman TA, Shultz SJ. Sport-specific biomechanical responses to an ACL injury prevention programme: A randomised controlled trial. J Sports Sci. 2018 Nov;36(21):2492-2501. doi: 10.1080/02640414.2018.1465723. Epub 2018 Apr 19.
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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.
Jeffrey B Taylor, DPT principal investigator
High Point University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular Prevention Program in people with Anterior Cruciate Ligament Injury, run by High Point University at 1 site in United States.
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 1 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 8 Jan 2016. 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 United States. 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?
Lower Extremity Angular Kinematics (hip flexion, hip adduction, hip internal rotation, knee flexion, abduction, knee internal rotation, knee external rotation) (time frame: 6-8 weeks). The study lists 2 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 NCT02530333, which also lists 2 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 8 Jan 2016.