Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001188123p
Ethics application status
Submitted, not yet approved
Date submitted
1/08/2019
Date registered
26/08/2019
Date last updated
26/08/2019
Date data sharing statement initially provided
26/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of individualized injury prevention pograms on risk of athletic knee injuries
Scientific title
Effectiveness of individualizing injury prevention program based on proximal stability deficit risk profiles on preventing athletic knee injuries
Secondary ID [1] 298876 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anterior Cruciate Ligament Injuries 313842 0
Knee injuries 313843 0
Condition category
Condition code
Musculoskeletal 312239 312239 0 0
Other muscular and skeletal disorders
Injuries and Accidents 312240 312240 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Exposure group will perform their usual warmup, followed by 10 mins proximal stability training at the end of the training session.

These exposures will occur during warm-up at bi- or tri-weekly club training sessions, for 8 weeks. The 8-week intervention will be supervised by the coaching staff. There will be a training session prior to commencement of intervention by a Australian Health Practitioner Regulation Agency registered Physiotherapist. The mode of administration will be in a group of 12-20 players per age group depending on club training policies.

Proximal stability training consists of 6 exercises in the following categories - trunk flexion, lateral trunk flexion, prone trunk stability, single-leg anterior stability, single leg lateral stability, single leg rotatory stability at the end of training. that are based on previously published reports and pilot work. Specific information on the exercises, recommended intensities, sets, and repetitions may be found in this paper - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2586107/

The exercises are self-limiting, and participants should perform them with optimum technique and/or to technical failure depending on the type of exercise. There will be no prescribed level of intensity. If the participant fatigues to a point that they can no longer perform the exercise with near-perfect form, or displays a sharp decline in proficiency, then they will be instructed to stop. The intensity of these exercises are not intended to match the intensity at which the control group will be performing their drills, and vice versa.

Adherence will be monitored through club attendance log managed by respective managers and coaches of each age group. They will be overseen by club technical director and research team.
Intervention code [1] 315140 0
Early detection / Screening
Intervention code [2] 315141 0
Prevention
Comparator / control treatment
Control group will perform their usual warmup, followed by soccer-specific drills for 10mins at the end of the training session.

These exposures will occur during warm-up at bi- or tri-weekly club training sessions, for 8 weeks. The 8-week intervention will be supervised by the coaching staff. There will be a training session prior to commencement of intervention by a Australian Health Practitioner Regulation Agency registered Physiotherapist. The mode of administration will be in a group of 12-20 players per age group depending on club training policies.

Soccer specific drills include 1. Free kick practice 2. Corner kick practice 3. Penalty kick practice 4. Straight line forward jogging

The soccer-specific drills are self-limiting, and participants should perform them with optimum technique and/or to technical failure depending on the type of drill. There will be no prescribed level of intensity. If the participant fatigues to a point that they can no longer perform the drill with near-perfect form, or displays a sharp decline in proficiency, then they will be instructed to stop. These intensity of these drills are not intended to match the intensity at which the intervention group will be performing their exercises, and vice versa.

Adherence will be monitored through club attendance log managed by respective managers and coaches of each age group. They will be overseen by club technical director and research team.
Control group
Active

Outcomes
Primary outcome [1] 320890 0
Sagittal and coronal trunk and hip biomechanics during change-of-direction, single-leg drop jump landing, and double-leg drop jump landing tasks using 3-Dimensional Biomechanical Motion Analysis and wearable IMUs.
Timepoint [1] 320890 0
Pre- (week 0 - baseline) and post-intervention (weeks 9-10)
Primary outcome [2] 321103 0
Trunk and hip stability measured using clinical tests (Biering-Sorensen test, side-plank, sit-ups, bent-knee fall-out test, knee lift abdominal test, hip strength measured with hand held dynamometer, single-leg hamstring bridge).
Timepoint [2] 321103 0
Pre- (week 0 - baseline) and post-intervention (weeks 9-10)
Secondary outcome [1] 373260 0
Severity of injuries.

Injuries defined as an event that occurred during athletic participation that required an athlete to be removed from a practice or match-play, or to miss at least one full day of practice, match-play, or sport participation.

Severity defined as total number of consecutive training and match-play days missed due to that injury.

An injury surveillance system will be implemented throughout the 8-week intervention. A weekly knee-injury questionnaire will be sent via email to the participants to report any knee injuries that occurred during the week. An automated email will be sent after 2 days of non-response. A member of the research team will telephone the participants following another 2 days of non-response. An Australian Health Practitioner Regulation Agency registered Physiotherapist from the research team will perform a telephone interview with injured participants within one week of the injury to collect information about the anatomic location and mechanism of injury, and the presenting complaints due to the injury. Depending on the injury, players will be provided with a diagnosis, and given management advice. A referral to another medical professional will be made if an escalation of care is required. Players will be interviewed weekly until the resolution of their injury and full sport participation is resumed.
Timepoint [1] 373260 0
Weekly - during 8-week intervention period
Secondary outcome [2] 373718 0
Knee injury count

Injuries defined as an event that occurred during athletic participation that required an athlete to be removed from a practice or match-play, or to miss at least one full day of practice, match-play, or sport participation.

An injury surveillance system will be implemented throughout the 8-week intervention. A weekly knee-injury questionnaire will be sent via email to the participants to report any knee injuries that occurred during the week. An automated email will be sent after 2 days of non-response. A member of the research team will telephone the participants following another 2 days of non-response. An Australian Health Practitioner Regulation Agency registered Physiotherapist from the research team will perform a telephone interview with injured participants within one week of the injury to collect information about the anatomic location and mechanism of injury, and the presenting complaints due to the injury. Depending on the injury, players will be provided with a diagnosis, and given management advice. A referral to another medical professional will be made if an escalation of care is required. Players will be interviewed weekly until the resolution of their injury and full sport participation is resumed.
Timepoint [2] 373718 0
Weekly - during 8-week intervention period
Secondary outcome [3] 373719 0
Mechanism of injury

Injuries defined as an event that occurred during athletic participation that required an athlete to be removed from a practice or match-play, or to miss at least one full day of practice, match-play, or sport participation.

An injury surveillance system will be implemented throughout the 8-week intervention. A weekly knee-injury questionnaire will be sent via email to the participants to report any knee injuries that occurred during the week. An automated email will be sent after 2 days of non-response. A member of the research team will telephone the participants following another 2 days of non-response. An Australian Health Practitioner Regulation Agency registered Physiotherapist from the research team will perform a telephone interview with injured participants within one week of the injury to collect information about the anatomic location and mechanism of injury, and the presenting complaints due to the injury. Depending on the injury, players will be provided with a diagnosis, and given management advice. A referral to another medical professional will be made if an escalation of care is required. Players will be interviewed weekly until the resolution of their injury and full sport participation is resumed.
Timepoint [3] 373719 0
Weekly - during 8-week intervention period

Eligibility
Key inclusion criteria
Male and female; Male and female; 13-45 years old; athletes currently involved in competitive team-based invasion sport, regular team training at least twice per week, good physical capacity according to the Physical Activity Readiness Questionnaire (PAR-Q) (i.e. answered “NO” to all questions)
Minimum age
13 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria: athletes participating in non-invasion games/sports; current self-reported musculoskeletal disorder(s) or history of musculoskeletal conditions that required medical intervention for a period of more than 4 weeks during the past 12 months; previously diagnosed with a systemic, vestibular, balance, and/or cardiac disorder;suffered from medical condition 2 weeks before testing

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/01/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 303420 0
University
Name [1] 303420 0
The University of Sydney
Country [1] 303420 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney, Camperdown, NSW 2006
Country
Australia
Secondary sponsor category [1] 303596 0
None
Name [1] 303596 0
None
Address [1] 303596 0
None
Country [1] 303596 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 303951 0
The University of Sydney Human Research Ethics Committee 3
Ethics committee address [1] 303951 0
Ethics committee country [1] 303951 0
Australia
Date submitted for ethics approval [1] 303951 0
23/07/2019
Approval date [1] 303951 0
Ethics approval number [1] 303951 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95354 0
Prof Evangelos Pappas
Address 95354 0
The University of Sydney (Cumberland Campus)
Office O151
Lidcombe, NSW 2141, AUSTRALIA
Country 95354 0
Australia
Phone 95354 0
+61 2 93519188
Fax 95354 0
Email 95354 0
[email protected]
Contact person for public queries
Name 95355 0
Evangelos Pappas
Address 95355 0
The University of Sydney (Cumberland Campus)
Office O151
Lidcombe, NSW 2141, AUSTRALIA
Country 95355 0
Australia
Phone 95355 0
+61 2 93519188
Fax 95355 0
Email 95355 0
[email protected]
Contact person for scientific queries
Name 95356 0
Evangelos Pappas
Address 95356 0
The University of Sydney (Cumberland Campus)
Office O151
Lidcombe, NSW 2141, AUSTRALIA
Country 95356 0
Australia
Phone 95356 0
+61 2 93519188
Fax 95356 0
Email 95356 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only
When will data be available (start and end dates)?
6 months following publication of main results; no end-date
Available to whom?
Only researchers who provide a methodologically sound proposal and at the discretion of Primary Sponsor
Available for what types of analyses?
Meta-analyses
How or where can data be obtained?
Contacting Principal Investigato, Professor Evangelos Pappas

E [email protected]
T + (61) 2 93519188
A O151 – Cumberland Campus, The University of Sydney (Cumberland Campus), Lidcombe NSW 2141 AUSTRALIA


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.