Prevention of Patellar and Achilles Tendinopathies in Youth Basketball

April 22, 2020 updated by: Carolyn Emery, Sport Injury Prevention Research Centre
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  1. 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.
  2. 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).
  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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
441

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2n1n4
        • Sport Injury Prevention Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

11 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Plays competitive basketball with School or club

Exclusion Criteria:

  • Injured at baseline

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Comprehensive Follow-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.
Other: Standard Follow-up
Research staff will monitor teams weekly, however no additional support for warm-up will be provided.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Medical attention injuries daily, additional injuries weekly and a post-season interview at 4 months if needed.
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.
This will be recorded weekly during the basketball season (average 4 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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)
Injury history, demographics, medical history
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.
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
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sport Injury Prevention Research Centre

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
General Electric
National Basketball Association

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Carolyn Emery, PT, PhD, Sport Injury Prevention Research Centre, University of Calgary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 10, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REB16-0864

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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