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Trial registered on ANZCTR


Registration number
ACTRN12618001591246
Ethics application status
Approved
Date submitted
12/09/2018
Date registered
25/09/2018
Date last updated
29/08/2019
Date data sharing statement initially provided
29/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Studying the effects of prophylactic knee braces in healthy active individuals
Scientific title
The effects of prophylactic knee braces on kinematics, kinetics, muscle forces, and ligament forces during sports maneuvers and physical perturbations in healthy active individuals
Secondary ID [1] 296066 0
Nil known
Universal Trial Number (UTN)
U1111-1220-3606
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee injuries prevention 309624 0
Condition category
Condition code
Musculoskeletal 308438 308438 0 0
Other muscular and skeletal disorders
Injuries and Accidents 308515 308515 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Knee injuries are prevalent in many sporting activities, which often involve high demand manoeuvres such as landing. The anterior cruciate ligament (ACL) is a strong stabilising ligament between the femur and tibia bones; however, the ACL is susceptible to rupture during landing and sports. The overall goal of this study is to provide insight into the efficacy of prophylactic braces in stabilising the knee and reducing the risk of injury. By collecting non-injurious and non-invasive motion analysis data while participants perform a series of motions: walking at a speed of 1.1 m/s, running at speed of 2.0 m/s, walking at a speed of 1.1 m/s with physical perturbations, drop landing tasks from heights of 30cm and 60cm on both legs and on a single leg, squats, side steps, and plant and cut movements. These motions will be completed 3 times, once with no braces (control), once with a set of sports braces (POD Active K8) braces on both knees, and once with a set of military braces (SpringLoaded Technology Upshot) on both knees, in random order. Five repetitions of each motion is performed. Each set of braces are worn until all motions are performed (Approx 45 minutes) with a 10-minute sitting down resting period between each full set of trials (wash-out period). The trials are conducted/supervised by a PhD student: Raneem Haddara.


There is a subsection of the study that is only applicable to army soldiers. Soldiers perform a 10-minute walking trial while wearing a 25 kg backpack with and without braces. This trial is performed approximately 20 minutes after the completion of the set of trials that were previously mentioned.

The studies will be undergone at The University of Melbourne where we will be using a virtual reality rehabilitation system called Computer Assisted Rehabilitation Environment (CAREN). The study will be conducted by a PhD student that is certified to operate the CAREN and has experience in biomechanics studies and human movement experiments.
Intervention code [1] 312408 0
Prevention
Comparator / control treatment
The subjects perform the same set of motions 3 times, one of them are with no braces (i.e. control)
Control group
Active

Outcomes
Primary outcome [1] 307419 0
ACL strain will be calculated computationally using musculoskeletal modelling software (OpenSim). This data is based on kinematics of the subject.
Timepoint [1] 307419 0
The ACL strain is analysed from data collected/recorded. The strain is calculated for each motion and averaged using a computational modelling software called OpenSim. This is done after the experiment is completed. Only one set of data is collected and the subjects are not back for re-analysis.
Secondary outcome [1] 351862 0
Kinematics will be calculated computationally using musculoskeletal modelling software (OpenSim). This data is based on kinematics of the subject.
Timepoint [1] 351862 0
Kinematics are analysed from data collected/recorded. The joint angles are calculated for each motion and averaged using a computational modelling software called OpenSim. This is done after the experiment is completed. Only one set of data is collected and the subjects are not back for re-analysis.
Secondary outcome [2] 352056 0
Kinetics will be calculated computationally using musculoskeletal modelling software (OpenSim). This data is based on kinematics of the subject and ground reaction forces from the force plates underneath them.
Timepoint [2] 352056 0
Kinetics are calculated from data collected/recorded. The joint moments are calculated for each motion and averaged using a computational modelling software called OpenSim. This is done after the experiment is completed. Only one set of data is collected and the subjects are not back for re-analysis.
Secondary outcome [3] 352057 0
Muscle forces will be calculated computationally using musculoskeletal modelling software (OpenSim). This data is based on kinematics of the subject and the ground reaction forces.
Timepoint [3] 352057 0
Muscle forces are calculated from data collected/recorded. The muscle forces are calculated for each motion and averaged using a computational modelling software called OpenSim. This is done after the experiment is completed. Only one set of data is collected and the subjects are not back for re-analysis.

Eligibility
Key inclusion criteria
You can participate in the study if you are between the ages of 18-45 years old and have been free from lower limb injury or surgery in the past six months. In addition, you must participate in regular exercises and have experience with jumping and landing activities (e.g. basketball, netball, volleyball, etc.). For the load carriage trials, the subject needs to fall within the previously mentioned criteria and be an army soldier.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
You are NOT eligible if you have a history of permanent lower extremity injuries (e.g. ligament tear, fractures) or diseases (e.g. osteoarthritis, rheumatoid arthritis).

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)
Allocation not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence of which braces to put on first was randomised by simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation). However, all subjects performed the study with both types of braces and no braces.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
19/07/2018
Date of last participant enrolment
Anticipated
31/10/2018
Actual
1/05/2019
Date of last data collection
Anticipated
23/11/2018
Actual
1/05/2019
Sample size
Target
15
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 300656 0
University
Name [1] 300656 0
University of Melbourne
Country [1] 300656 0
Australia
Funding source category [2] 300662 0
Government body
Name [2] 300662 0
Department of Defence, Science, and Technology (DST)
Country [2] 300662 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Parkville, Vic, 3010
Country
Australia
Secondary sponsor category [1] 300172 0
Government body
Name [1] 300172 0
Department of Defence, Science, and Technology (DST)
Address [1] 300172 0
506 Lorimer St, Port Melbourne VIC 3207
Country [1] 300172 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301441 0
Psychology Health and Applied Sciences Sub-Committee (94360 - Mechanical Engineering)
Ethics committee address [1] 301441 0
Research Ethics & Integrity
Level 4, 161 Barry Street
The University of Melbourne
VIC 3010
Ethics committee country [1] 301441 0
Australia
Date submitted for ethics approval [1] 301441 0
Approval date [1] 301441 0
26/10/2017
Ethics approval number [1] 301441 0
1034932

Summary
Brief summary
Knee injuries are very prevalent and affect individuals everyday. Some knee injuries, like an anterior cruciate ligament tear (ACL) can result in irreversible damage where only a small portion of the individuals are able to come back to pre-injury level, despite surgery and physical therapy. As a result, injury prevention knee braces emerged as a way of protecting the knees from injuries during high risk activities like sports. The effectiveness of these braces have been controversial and we aim to study the braces in a more realistic environment by using a virtual reality system that can fully immerse our subjects and deliver unanticipated perturbations while the subjects are safely harnessed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87010 0
Prof Peter Vee Sin Lee
Address 87010 0
Department of Biomedical Engineering, The University of Melbourne. Level 3, Mechanical Engineering Building, Block E, Parkville, Vic, 3010
Country 87010 0
Australia
Phone 87010 0
+61 3 83444426
Fax 87010 0
Email 87010 0
[email protected]
Contact person for public queries
Name 87011 0
Peter Vee Sin Lee
Address 87011 0
Department of Biomedical Engineering, The University of Melbourne. Level 3, Mechanical Engineering Building, Block E, Parkville, Vic, 3010
Country 87011 0
Australia
Phone 87011 0
+61 3 83444426
Fax 87011 0
Email 87011 0
[email protected]
Contact person for scientific queries
Name 87012 0
Peter Vee Sin Lee
Address 87012 0
Department of Biomedical Engineering, The University of Melbourne. Level 3, Mechanical Engineering Building, Block E, Parkville, Vic, 3010
Country 87012 0
Australia
Phone 87012 0
+61 3 83444426
Fax 87012 0
Email 87012 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will be mostly be averaged between participants.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4400Study protocol    Not available yet. Will be included in thesis and ... [More Details]
4401Statistical analysis plan    Not available yet. Will be included in thesis and ... [More Details]
4402Informed consent form    Not available yet. Will be included in thesis and ... [More Details]
4403Ethical approval    Not available yet. Will be included in thesis and ... [More Details]



Results publications and other study-related documents

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