Injury, KneeNCT04363398
Prevention of Patellar and Achilles Tendinopathies in Youth Basketball
A study testing Comprehensive Follow-up and Standard Follow-up in people with Injury, Knee and Injury, Ankle, run by Sport Injury Prevention Research Centre at 1 site in Canada.
Trial summary
This study seeks to determine the prevalence of knee and ankle tendinopathies in youth basketball players, as well as determine the efficacy of a Basketball specific Neuromuscular training warm-up in reducing injuries. Read more about this study
- Who is it for?
- Ages 11 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Injury, Knee, Injury, Ankle, Tendinopathy
- What is being tested?
- Comprehensive Follow-up and Standard Follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 441 participants
- Where
- 1 siteCanada
- Study dates
- 10 Aug 2016to 31 Jul 2019
- 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 11 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Plays competitive basketball with School or club
Who cannot join
- Injured at baseline
Trial locations and contacts
1 site in 1 country.
About this study
This study seeks to determine the prevalence of knee and ankle tendinopathies in youth basketball players, as well as determine the efficacy of a Basketball specific Neuromuscular training warm-up in reducing injuries.
Read the detailed description
- BACKGROUND \& RATIONALE Basketball is one of the most popular youth sports in the United States and Canada. Knee and ankle injuries are the most common injuries in youth basketball (40%). Patellar and Achilles tendinopathies (PATs) are of particular concern in elite level basketball with a prevalence of 32% for patellar tendinopathy in elite male athletes (60% career prevalence). The risk for injury may be initiated in youth basketball where overuse injury incidence increases with age. Previously reported PAT injury rates likely underestimate the burden of overuse injury in youth basketball as current surveillance guidelines are optimized for acute injury and there are no guidelines on appropriate tendinopathy diagnosis in youth athletes. Current knowledge on basketball-related injuries (acute and overuse) in adolescent athletic community is sparse. Jump loads, landing mechanics, joint morphology and tendon structure changes may be predictive of tendinopathy. However, their consequences on PAT risk in basketball remain to be investigated using prospective cohort study methodologies. Encouragingly, the potential for mediating injury risk in youth sport through neuromuscular training programs has been demonstrated. A basketball specific neuromuscular training program (BSpecNMT) in turn may be efficacious for primary PAT prevention. Clearly, there is an urgent need to advance the current state of injury surveillance, prevention programs, sport-specific risk factors for PATs and structural consequences of PATs in youth basketball.
- RESEARCH OBJECTIVES Primary Objectives 1) To quantify the prevalence and severity of patellar and Achilles tendinopathies and assess associated risk factors in youth basketball (Year 1); and 2) To evaluate the efficacy of a BSpecNMT program in reducing patellar and Achilles tendinopathies and all injuries in youth basketball players (Year 2 and 3).
- METHODS A Hybrid (effectiveness-implementation) Type 2 RCT design will be conducted. Teams will be randomized into either a comprehensive or standard intervention delivery group. All coaches will attend one pre-season coach workshop for the basketball specific neuromuscular (BSpecNMT) warm-up program. The workshop was led by a physiotherapist, athletic trainer, or strength and conditioning coach before the start of the season. During the pre-season coach workshop, coaches will take part in a theoretical and practical session about basketball injury prevention and warm-up exercises. Coaches in the both study groups will be instructed to carry out the 10-minute warm-up program at the beginning of all training sessions.
In addition, the comprehensive intervention group will receive weekly visits at team practices from a research physiotherapist, athletic trainer, or strength and conditioning coach. These visits will provide the team guidance with the BSpecNMT warm-up to facilitate proper technique and appropriate progression of the BSpecNMT warm-up exercises.
All teams will have their adherence to the BSpecNMT recorded on a weekly basis by a Team Designate. In addition, injuries will be prospectively monitored through a weekly self-report questionnaire, a post-season questionnaire (completed by players) and injury report form (completed by team designates). Also, Coaches' knowledge and attitudes to injury prevention will be registered by surveys during the pre-season, post-workshop, post-season, 6-month post-season, and 12-month post-season timepoints.
- Conditions
- Injury, Knee, Injury, Ankle, Tendinopathy, Sports Injuries in Children
- Being tested
- Comprehensive Follow-up, Standard Follow-up
- Medical subject headings
- Knee Injuries, Ankle Injuries, Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Follow-upOther
Trained research staff members will provide weekly support to coaches on the NMT warm-up.
Standard Follow-upOther
Research staff will monitor teams weekly, however no additional support for warm-up will be provided.
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive | Experimental | Coaches from schools randomized to the comprehensive follow-up receive a workshop outlining a neuromuscular training program to be used as a warm-up for 10 minutes at the beginning of each basketball practice and game. Throughout the season, a trained research team member will monitor the team weekly for injuries, participation, and adherence, and provide support to the school coaches regarding the warm-up. Receives: Other: Comprehensive Follow-up |
| Standard | Active comparator | Coaches from schools randomized to the standard follow-up receive a workshop outlining a neuromuscular training program to be used as a warm-up for 10 minutes at the beginning of each basketball practice and game. Throughout the season, a research team member will monitor the team weekly for injuries, participation, and adherence, however will not provide support to the school coaches regarding the warm-up. Receives: Other: Standard Follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Basketball injuries
To effectively capture all injuries (i.e., acute and overuse/chronic injuries), an "all-complaint" injury definition will be adopted through year 1 and year 2 of study. An injury is any physical complaint, including any pain, ache, joint instability, stiffness or any other complaint resulting from participating in basketball-related sessions, including but irrespective of the need for medical attention (seeking care from a trainer or medical practitioner) or time-loss (inability to complete a basketball-related session, or participate in one or more days after the onset of injury) from basketball-related activities. Further, an injury is identified as acute if its onset was sudden and clearly associated with an identifiable event and overuse if its onset, whether gradual or sudden, was unidentifiable with any event.
Measured: Medical attention injuries daily, additional injuries weekly and a post-season interview at 4 months if needed.
Weekly Exposure Sheet (WES)
The duration of time players are exposed to basketball, and the basketball NMT program, will be captured. This will be captured using a previously validated Weekly Exposure Form (WES). This includes start and end time of sport sessions, attendance at those sessions, and reason for non-attendance.
Measured: This will be recorded weekly during the basketball season (average 4 months)
Secondary outcomes (2)
Player Questionnaire
Injury history, demographics, medical history
Measured: This measure will be assess at baseline (pre-season) and end of the basketball season (average 4 months after baseline)
Coach Beliefs/Behaviors
Coach knowledge, experiences, attitudes and beliefs of the coach related to injury prevention and the neuromuscular training program will be assessed through a previously validated Health Action Process Approach questionnaire adapted in previous studies in a similar setting
Measured: The questionnaire will be administered to team coaches at 4 different time-points - Pre-workshop at baseline, post workshop at baseline, post-season at 4 months, post-season follow-up at 6 months and post-season follow-up at 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start10 Aug 2016
- Primary completion31 Jul 2018
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injury, KneeStudies 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
- Model description
- A Hybrid (effectiveness-implementation) Type 2 RCT design will be conducted. Teams will be randomized into either a comprehensive or standard intervention delivery group.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 441 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sport Injury Prevention Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- General Electric, National Basketball Association
- Responsible party
- Principal investigator, Carolyn Emery, Sport Injury Prevention Research Centre
- Investigators
- Carolyn Emery, PT, PhD, Principal investigator, Sport Injury Prevention Research Centre, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04363398
- Sponsor's protocol ID
- REB16-0864
- Status last verified
- Apr 2020
- First submitted
- 27 Apr 2018
- Last updated
- 27 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Patellar and Achilles Tendinopathies in Youth Basketball
- ClinicalTrials.gov ID
- NCT04363398
- Acronym / sponsor ID
- REB16-0864
- Conditions
- Injury, Knee, Injury, Ankle, Tendinopathy, Sports Injuries in Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 441 participants (actual)
- Lead sponsor
- Sport Injury Prevention Research CentreUniversity, hospital or other
- Collaborators
- General Electric, National Basketball Association
- Study start
- 10 Aug 2016 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 27 Apr 2020 (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.
This study seeks to determine the prevalence of knee and ankle tendinopathies in youth basketball players, as well as determine the efficacy of a Basketball specific Neuromuscular training warm-up in reducing injuries.
Detailed description
- BACKGROUND \& RATIONALE Basketball is one of the most popular youth sports in the United States and Canada. Knee and ankle injuries are the most common injuries in youth basketball (40%). Patellar and Achilles tendinopathies (PATs) are of particular concern in elite level basketball with a prevalence of 32% for patellar tendinopathy in elite male athletes (60% career prevalence). The risk for injury may be initiated in youth basketball where overuse injury incidence increases with age. Previously reported PAT injury rates likely underestimate the burden of overuse injury in youth basketball as current surveillance guidelines are optimized for acute injury and there are no guidelines on appropriate tendinopathy diagnosis in youth athletes. Current knowledge on basketball-related injuries (acute and overuse) in adolescent athletic community is sparse. Jump loads, landing mechanics, joint morphology and tendon structure changes may be predictive of tendinopathy. However, their consequences on PAT risk in basketball remain to be investigated using prospective cohort study methodologies. Encouragingly, the potential for mediating injury risk in youth sport through neuromuscular training programs has been demonstrated. A basketball specific neuromuscular training program (BSpecNMT) in turn may be efficacious for primary PAT prevention. Clearly, there is an urgent need to advance the current state of injury surveillance, prevention programs, sport-specific risk factors for PATs and structural consequences of PATs in youth basketball.
- RESEARCH OBJECTIVES Primary Objectives 1) To quantify the prevalence and severity of patellar and Achilles tendinopathies and assess associated risk factors in youth basketball (Year 1); and 2) To evaluate the efficacy of a BSpecNMT program in reducing patellar and Achilles tendinopathies and all injuries in youth basketball players (Year 2 and 3).
- METHODS A Hybrid (effectiveness-implementation) Type 2 RCT design will be conducted. Teams will be randomized into either a comprehensive or standard intervention delivery group. All coaches will attend one pre-season coach workshop for the basketball specific neuromuscular (BSpecNMT) warm-up program. The workshop was led by a physiotherapist, athletic trainer, or strength and conditioning coach before the start of the season. During the pre-season coach workshop, coaches will take part in a theoretical and practical session about basketball injury prevention and warm-up exercises. Coaches in the both study groups will be instructed to carry out the 10-minute warm-up program at the beginning of all training sessions.
In addition, the comprehensive intervention group will receive weekly visits at team practices from a research physiotherapist, athletic trainer, or strength and conditioning coach. These visits will provide the team guidance with the BSpecNMT warm-up to facilitate proper technique and appropriate progression of the BSpecNMT warm-up exercises.
All teams will have their adherence to the BSpecNMT recorded on a weekly basis by a Team Designate. In addition, injuries will be prospectively monitored through a weekly self-report questionnaire, a post-season questionnaire (completed by players) and injury report form (completed by team designates). Also, Coaches' knowledge and attitudes to injury prevention will be registered by surveys during the pre-season, post-workshop, post-season, 6-month post-season, and 12-month post-season timepoints.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A Hybrid (effectiveness-implementation) Type 2 RCT design will be conducted. Teams will be randomized into either a comprehensive or standard intervention delivery group.
| Arm | Type | Receives |
|---|---|---|
| Comprehensive | Experimental | Other: Comprehensive Follow-upCoaches from schools randomized to the comprehensive follow-up receive a workshop outlining a neuromuscular training program to be used as a warm-up for 10 minutes at the beginning of each basketball practice and game. Throughout the season, a trained research team member will monitor the team weekly for injuries, participation, and adherence, and provide support to the school coaches regarding the warm-up. |
| Standard | Active comparator | Other: Standard Follow-upCoaches from schools randomized to the standard follow-up receive a workshop outlining a neuromuscular training program to be used as a warm-up for 10 minutes at the beginning of each basketball practice and game. Throughout the season, a research team member will monitor the team weekly for injuries, participation, and adherence, however will not provide support to the school coaches regarding the warm-up. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Plays competitive basketball with School or club
Key exclusion criteria (1 listed)
- Injured at baseline
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 |
|---|---|---|
| Comprehensive Follow-upTrained research staff members will provide weekly support to coaches on the NMT warm-up. | Other | Comprehensive |
| Standard Follow-upResearch staff will monitor teams weekly, however no additional support for warm-up will be provided. | Other | Standard |
Primary outcome
Basketball injuries
Time frame: Medical attention injuries daily, additional injuries weekly and a post-season interview at 4 months if needed.
To effectively capture all injuries (i.e., acute and overuse/chronic injuries), an "all-complaint" injury definition will be adopted through year 1 and year 2 of study. An injury is any physical complaint, including any pain, ache, joint instability, stiffness or any other complaint resulting from participating in basketball-related sessions, including but irrespective of the need for medical attention (seeking care from a trainer or medical practitioner) or time-loss (inability to complete a basketball-related session, or participate in one or more days after the onset of injury) from basketball-related activities. Further, an injury is identified as acute if its onset was sudden and clearly associated with an identifiable event and overuse if its onset, whether gradual or sudden, was unidentifiable with any event.
Weekly Exposure Sheet (WES)
Time frame: This will be recorded weekly during the basketball season (average 4 months)
The duration of time players are exposed to basketball, and the basketball NMT program, will be captured. This will be captured using a previously validated Weekly Exposure Form (WES). This includes start and end time of sport sessions, attendance at those sessions, and reason for non-attendance.
2 secondary outcomes
Player Questionnaire
Time frame: This measure will be assess at baseline (pre-season) and end of the basketball season (average 4 months after baseline)
Coach Beliefs/Behaviors
Time frame: The questionnaire will be administered to team coaches at 4 different time-points - Pre-workshop at baseline, post workshop at baseline, post-season at 4 months, post-season follow-up at 6 months and post-season follow-up at 12 months.
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 27 Apr 2020.
- Individual participant dataSharing planned: No
Related trials for Injury, Knee
Not yet recruiting
Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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
Effects of Pulsed Electromagnetic Field Therapy on Meniscal Healing, Symptom Relief, and Knee Function
Meniscal Tears
Not yet recruiting
Negative Pressure Wound Therapy Devices in Total Knee Arthroplasty
Wound Surgical, Diabetes
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.
Carolyn Emery, PT, PhD principal investigator
Sport Injury Prevention Research Centre, University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive Follow-up and Standard Follow-up in people with Injury, Knee and Injury, Ankle, run by Sport Injury Prevention Research Centre 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 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 27 Apr 2020. 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.
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?
Basketball injuries (time frame: Medical attention injuries daily, additional injuries weekly and a post-season interview at 4 months if needed.). 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?
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 27 Apr 2020.