Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000982516
Ethics application status
Approved
Date submitted
29/08/2015
Date registered
21/09/2015
Date last updated
10/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Development and validation of basketball and netball specific injury prevention tools
Scientific title
Can a sport specific neuromuscular warm up improve landing biomechanics in healthy netball and basketball players?
Secondary ID [1] 287370 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Injury 296047 0
Lower extremity injuries 296144 0
Condition category
Condition code
Musculoskeletal 296318 296318 0 0
Other muscular and skeletal disorders
Injuries and Accidents 296416 296416 0 0
Other injuries and accidents
Physical Medicine / Rehabilitation 296417 296417 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1 – athletes under take screening tests looking at balance (Standing Excursion Balance test, single leg squat) and Landing technique (Drop Vertical Jump, hopping, box drop landing). The control group receive no intervention or feedback, and athletes continue with their normal training.

Arm 2 – athletes under take the same screening tests, and are randomly allocated to the intervention group. The intervention involves a neuromuscular warm up, to be conducted at the start of team trainings and games, instead of the usual team warm up. The intervention exercises will take 15 minutes, equivalent to time typically allocated to team warm ups. Athletes will be re assessed at 6 weeks and 6 months

WARM UP INCLUDES:
Jogging, side steps, dynamic stretching (3 mins)
Strength/activation exercises (e.g lunges, nordic lowers, single leg stability) - 4 mins
Balance/Proprioception - double and single leg landing practice, in all directions. Introduce light perturbations and landing with arms overhead. (3 minutes)
Functional Agility: cutting movements, quick acceleration and deceleration, including unanticipated change in direction (3 mins)

Sport Specific Movement patterns: 1 on 1 offence vs defence cutting, sidesteps. 2 minutes
Intervention code [1] 292713 0
Early detection / Screening
Intervention code [2] 292714 0
Prevention
Comparator / control treatment
Athletes will continue with their usual warm up
Control group
Active

Outcomes
Primary outcome [1] 295971 0
Landing Error Scoring System rating based on video analysis of landing technique
Timepoint [1] 295971 0
Time point: at initial recruitment, 6 weeks, and 6 months
Primary outcome [2] 295972 0
Lower extremity biomechanics using DorsaVi, assessed during landing task
Timepoint [2] 295972 0
at initial recruitment, 6 weeks and 6 months
Secondary outcome [1] 317081 0
Standing Excursion Balance Test
Timepoint [1] 317081 0
at initial recruitment, 6 weeks and 6 months

Eligibility
Key inclusion criteria
Basketball or Netball players
Minimum age
14 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
recent ( < 3 months) significant lower limb injury or surgery , or pain that may preclude physical activity.

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)
Randomisation will be in the form of cluster randomisation. Teams will be recruited to participate in the study. Athletes in each participating team will be provided with a patient information statement, and consent form. Once players from the team have returned their consent forms, the team will be allocated randomly to control or intervention group via contacting the holder of the allocation schedule who is off site at a central administration site (allocation concealment). Teams in the control group will not be informed about the content of the intervention exercises to prevent contamination.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Cluster randomisation of teams will occur via simple randomisation, using a computerised sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Linear mixed models will be used to assess the effect of the intervention on athletic task biomechanics. Chi square tests will test for differences in injury rates between the two groups. Multivariable regression models will be used to indentify predictors of injury

The primary outcome measure will be the Landing Error Scoring System (LESS), which has been shown to be a valid and reliable clinical assessment tool for the biomechanics of jump landing (d. Padua, Marshall, & Boling, 2009).
A recent study by Padua et al (2015) found that injured participants scored 1.81 points higher on the LESS than uninjured subjects, which knee experts would consider to be a large, and clinically meaningful difference. Standard deviations of the LESS assessment range between 1.68 and 2 ((d. Padua et al., 2009; D. A. Padua et al., 2015; Smith, Johnson, & Shultz, 2012)

An apriori power analysis was conducted using a mean difference of 1.8, with a conservative SD of 2.0. A T- test with two tails was performed, determining a total sample size for each group to be 19.

Similar studies following teams in season have found subject drop outs of up to 25%. To account for subject drop out, we would plan on recruiting 30 athletes for each group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2015
Actual
11/01/2016
Date of last participant enrolment
Anticipated
1/11/2017
Actual
1/05/2016
Date of last data collection
Anticipated
21/11/2016
Actual
9/11/2016
Sample size
Target
60
Accrual to date
Final
51
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment postcode(s) [1] 10221 0
2006 - The University Of Sydney

Funding & Sponsors
Funding source category [1] 291929 0
Self funded/Unfunded
Name [1] 291929 0
Country [1] 291929 0
Primary sponsor type
University
Name
University of Sydney
Address
University of Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 290598 0
None
Name [1] 290598 0
Address [1] 290598 0
Country [1] 290598 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293432 0
Human Research Ethics Committee University of Sydney
Ethics committee address [1] 293432 0
Ethics committee country [1] 293432 0
Australia
Date submitted for ethics approval [1] 293432 0
Approval date [1] 293432 0
28/07/2015
Ethics approval number [1] 293432 0
2015/267

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

Contacts
Principal investigator
Name 59910 0
Mr David Hillard
Address 59910 0
AMRG,
School of Physiotherapy,
University of Sydney
75 East St,
Lidcombe
NSW 2141
Country 59910 0
Australia
Phone 59910 0
+61 401 752 850
Fax 59910 0
Email 59910 0
[email protected]
Contact person for public queries
Name 59911 0
David Hillard
Address 59911 0
AMRG,
School of Physiotherapy,
University of Sydney
75 East St,
Lidcombe
NSW 2141
Country 59911 0
Australia
Phone 59911 0
+61 401 752 850
Fax 59911 0
Email 59911 0
[email protected]
Contact person for scientific queries
Name 59912 0
David Hillard
Address 59912 0
AMRG,
School of Physiotherapy,
University of Sydney
75 East St,
Lidcombe
NSW 2141
Country 59912 0
Australia
Phone 59912 0
+61 401 752 850
Fax 59912 0
Email 59912 0
[email protected]

No information has been provided regarding IPD availability


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.