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Prevention of Patellar and Achilles Tendinopathies in Youth Basketball

Primary Purpose

Injury, Knee, Injury, Ankle, Tendinopathy

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Comprehensive Follow-up
Standard Follow-up
Sponsored by
Sport Injury Prevention Research Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Injury, Knee

Eligibility Criteria

11 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Plays competitive basketball with School or club

Exclusion Criteria:

  • Injured at baseline

Sites / Locations

  • Sport Injury Prevention Research Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Comprehensive

Standard

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Player Questionnaire
Injury history, demographics, medical history
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

Full Information

First Posted
April 27, 2018
Last Updated
April 22, 2020
Sponsor
Sport Injury Prevention Research Centre
Collaborators
General Electric, National Basketball Association
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1. Study Identification

Unique Protocol Identification Number
NCT04363398
Brief Title
Prevention of Patellar and Achilles Tendinopathies in Youth Basketball
Official Title
Prevention of Patellar and Achilles Tendinopathies in Youth Basketball
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
August 10, 2016 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sport Injury Prevention Research Centre
Collaborators
General Electric, National Basketball Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Injury, Knee, Injury, Ankle, Tendinopathy, Sports Injuries in Children

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigator
Masking Description
Participants (teachers and students) are not aware of what arm they are randomized to. The primary investigators performing the analysis and overseeing all decisions are blinded to the schools receiving the comprehensive vs standard follow-up.
Allocation
Randomized
Enrollment
441 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Comprehensive
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Comprehensive Follow-up
Intervention Description
Trained research staff members will provide weekly support to coaches on the NMT warm-up.
Intervention Type
Other
Intervention Name(s)
Standard Follow-up
Intervention Description
Research staff will monitor teams weekly, however no additional support for warm-up will be provided.
Primary Outcome Measure Information:
Title
Basketball injuries
Description
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.
Time Frame
Medical attention injuries daily, additional injuries weekly and a post-season interview at 4 months if needed.
Title
Weekly Exposure Sheet (WES)
Description
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.
Time Frame
This will be recorded weekly during the basketball season (average 4 months)
Secondary Outcome Measure Information:
Title
Player Questionnaire
Description
Injury history, demographics, medical history
Time Frame
This measure will be assess at baseline (pre-season) and end of the basketball season (average 4 months after baseline)
Title
Coach Beliefs/Behaviors
Description
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
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Plays competitive basketball with School or club Exclusion Criteria: Injured at baseline
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn Emery, PT, PhD
Organizational Affiliation
Sport Injury Prevention Research Centre, University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sport Injury Prevention Research Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2n1n4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Prevention of Patellar and Achilles Tendinopathies in Youth Basketball

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