Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000053527
Ethics application status
Approved
Date submitted
9/01/2015
Date registered
22/01/2015
Date last updated
22/01/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can an injury prevention program delivered during pre-week of Australian Defence Force (ADF) Infantry training lead to a decrease in preventable injuries amongst trainees: a randomized controlled trial.
Scientific title
Can a 2 hour presentation on intrinsic and extrinsic injury risks, injury risk management and biomechanical awareness given to Infantry trainees in their pre-week of training decrease the number of trainees sustaining preventable injuries ie, those that are caused through over-use, overloading or poor biomechanics.
Secondary ID [1] 285914 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Musculoskeletal Injuries sustained within the Infantry trainee population 293832 0
Condition category
Condition code
Injuries and Accidents 294133 294133 0 0
Other injuries and accidents
Physical Medicine / Rehabilitation 294247 294247 0 0
Physiotherapy
Musculoskeletal 294248 294248 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
On the Tuesday of pre-week (that is the week before IET training commences)
1. All members in the intervention groups will be given a questionnaire to fill in regarding intrinsic risk factors to injury. BMI will be assessed.
2. The intervention group will receive a one hour theoretical session, delivered by the researchers, on intrinsic risk factors for injuries and how to take active steps to avoid injury (ten tips for injury prevention).
3. The intervention group will then receive a one hour small group practical session, delivered by the researchers, looking at biomechanics, posture and body awareness and the impact of these on minimising overuse/preventable injuries.
4. Trainees identified as having significant risk factor (for example pronating feet), or those who wish to have raise an issue with the physiotherapist will be given an individual assessment and intervention if required.
5. Details of trainees presentation to physiotherapy, treatment and injuries sustained will be recorded throughout their time in training
Intervention code [1] 290889 0
Prevention
Comparator / control treatment
1. All members in the control groups will be given a questionnaire to fill in regarding intrinsic risk factors to injury. BMI will be assessed.
2. Details of trainees presentation to physiotherapy, treatment and injuries sustained will be recorded throughout their time in training
Control group
Active

Outcomes
Primary outcome [1] 293936 0
Number of trainees sustaining preventable injuries during their Infantry training.

For the purposes of this study a preventable injury is defined as a non-traumatic injury occurring from overuse that can be linked to one or more intrinsic risk factors (such as poor biomechanics, history of a recurrent injury and so on). Assessment of an injury as preventable is made by the clinical judgement of the referring doctor and treating physiotherapist in consultation with the participants risk factor questionnaire completed at the beginning of the trial.
Timepoint [1] 293936 0
Injuries sustained during the 13 week IET training program
Secondary outcome [1] 312178 0
Correlation between injuries sustained and risk factors for injury highlighted in the questionnaire given to participants at the beginning of the trial, thus enabling validation of the IET Injury Prevention Program Questionnaire (IIPPQ).

This questionnaire has been developed specifically for this study after review of the literature to find, in general and in terms of the military, which intrinsic risk factors are the highest predictors for injury.
Timepoint [1] 312178 0
Injuries must be sustained during the 13 week IET training program

Eligibility
Key inclusion criteria
Any IET trainees that are to commence and complete their 13 week training course between the 30th January 2012 and the 31st December 2012.
Minimum age
17 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
No exclusion criteria

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
Completed
Date of first participant enrolment
Anticipated
30/01/2012
Actual
31/01/2012
Date of last participant enrolment
Anticipated
Actual
29/10/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
403
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 290524 0
Government body
Name [1] 290524 0
Australian Defence Force
Country [1] 290524 0
Australia
Primary sponsor type
Individual
Name
Rebecca Sellwood
Address
Physiotherapy Department
SMAHC
Lone Pine Barracks
Range Road
Singleton
NSW 2331
Country
Australia
Secondary sponsor category [1] 289219 0
Individual
Name [1] 289219 0
Carney Garland
Address [1] 289219 0
Physiotherapy Department
SMAHC
Lone Pine Barracks
Range Road
Singleton
NSW 2331
Country [1] 289219 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292175 0
ADHREC
Ethics committee address [1] 292175 0
Ethics committee country [1] 292175 0
Australia
Date submitted for ethics approval [1] 292175 0
Approval date [1] 292175 0
18/01/2012
Ethics approval number [1] 292175 0
641-11

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

Contacts
Principal investigator
Name 53802 0
Mrs Carney Garland
Address 53802 0
Physiotherapy Department
SMAHC
Lone Pine Barracks
Range Rd
Singleton
NSW 2331
Country 53802 0
Australia
Phone 53802 0
+61265750039
Fax 53802 0
Email 53802 0
[email protected]
Contact person for public queries
Name 53803 0
Rebecca Sellwood
Address 53803 0
Physiotherapy Department
SMAHC
Lone Pine Barracks
Range Rd
Singleton
NSW 2331
Country 53803 0
Australia
Phone 53803 0
+61429025918
Fax 53803 0
Email 53803 0
[email protected]
Contact person for scientific queries
Name 53804 0
Rebecca Sellwood
Address 53804 0
Physiotherapy Department
SMAHC
Lone Pine Barracks
Range Rd
Singleton
NSW 2331
Country 53804 0
Australia
Phone 53804 0
+61429025918
Fax 53804 0
Email 53804 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.