- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04363398
Prevention of Patellar and Achilles Tendinopathies in Youth Basketball
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alberta
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Calgary, Alberta, Canada, T2n1n4
- Sport Injury Prevention Research Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Plays competitive basketball with School or club
Exclusion Criteria:
- Injured at baseline
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Comprehensive
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.
|
Trained research staff members will provide weekly support to coaches on the NMT warm-up.
|
Active Comparator: Standard
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.
|
Research staff will monitor teams weekly, however no additional support for warm-up will be provided.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Medical attention injuries daily, additional injuries weekly and a post-season interview at 4 months if needed.
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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.
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This will be recorded weekly during the basketball season (average 4 months)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Player Questionnaire
Time Frame: This measure will be assess at baseline (pre-season) and end of the basketball season (average 4 months after baseline)
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Injury history, demographics, medical history
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This measure will be assess at baseline (pre-season) and end of the basketball season (average 4 months after baseline)
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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.
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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
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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.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Carolyn Emery, PT, PhD, Sport Injury Prevention Research Centre, University of Calgary
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REB16-0864
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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