Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001008617
Ethics application status
Approved
Date submitted
4/09/2023
Date registered
15/09/2023
Date last updated
15/09/2023
Date data sharing statement initially provided
15/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Immediate effects of an elastic knee brace for patients with ongoing symptoms following anterior cruciate ligament reconstruction
Scientific title
Immediate effects of an elastic knee brace for young adults at risk of knee osteoarthritis after anterior cruciate ligament reconstruction: a pilot study
Secondary ID [1] 310532 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anterior cruciate ligament reconstruction 331348 0
Post-traumatic osteoarthritis 331349 0
Condition category
Condition code
Physical Medicine / Rehabilitation 328100 328100 0 0
Physiotherapy
Musculoskeletal 328101 328101 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Genutrain Elastic Knee Brace (Bauerfeind® AG, Zeulenroda-Triebes, Germany), a Therapeutic Goods Administration (TGA) approved medical device. The brace will be sized and fitted appropriately as per manufacturer’s instructions.

Participants will undergo assessments twice within the same testing session supervised by a physiotherapist, once without the brace on and once with the brace on. The order of condition (brace vs no brace) will be randomised (1:1).

The functional and biomechanical assessments are detailed under “Outcomes”. In summary, these are: i) maximum hop for distance; ii) maximum hop for height; iii) single-leg drop vertical jump from 15cm high step; and iv) forward hop 100% of leg length.

The session will take approximately 3 hours. Approximately 15 minute rest/wash-out period will apply between the two conditions.
Intervention code [1] 326924 0
Treatment: Devices
Comparator / control treatment
No treatment.

The control condition is no brace use.
Control group
Active

Outcomes
Primary outcome [1] 335967 0
Lower-limb functional performance assessed with the hop for distance test
Timepoint [1] 335967 0
Immediate performance with and without brace
Primary outcome [2] 336055 0
Knee confidence on hop for distance test (visual analogue scale)
Timepoint [2] 336055 0
Immediately following each braced and unbraced condition
Secondary outcome [1] 426291 0
Knee pain on hop for distance test (visual analogue scale)
Timepoint [1] 426291 0
Immediately following each braced and unbraced condition
Secondary outcome [2] 426294 0
Vertical hop test assessing maximum hop height
Timepoint [2] 426294 0
Immediate performance with and without brace
Secondary outcome [3] 426295 0
Knee pain on vertical hop test (visual analogue scale)
Timepoint [3] 426295 0
Immediately following each braced and unbraced condition
Secondary outcome [4] 426296 0
Knee confidence on vertical hop test (visual analogue scale)
Timepoint [4] 426296 0
Immediately following each braced and unbraced condition
Secondary outcome [5] 426297 0
Biomechanics of walking at self-selected speed using 3D VICON system (infrared cameras tracking reflective markers)
Timepoint [5] 426297 0
Immediate performance with and without brace
Secondary outcome [6] 426298 0
Knee pain during walking (visual analogue scale)
Timepoint [6] 426298 0
Immediately following each braced and unbraced condition
Secondary outcome [7] 426299 0
Knee confidence during walking (visual analogue scale)
Timepoint [7] 426299 0
Immediately following each braced and unbraced condition
Secondary outcome [8] 426300 0
Biomechanics of hopping (drop-jump from 15cm height step)
Timepoint [8] 426300 0
Immediate performance with and without brace
Secondary outcome [9] 426702 0
Knee pain during drop jump (visual analogue scale)
Timepoint [9] 426702 0
Immediately following each braced and unbraced condition
Secondary outcome [10] 426703 0
Knee confidence during drop jump (visual analogue scale)
Timepoint [10] 426703 0
Immediately following each braced and unbraced condition
Secondary outcome [11] 426704 0
Biomechanics of hopping (two consecutive horizontal hops 100% of leg length)
Timepoint [11] 426704 0
Immediate performance with and without brace
Secondary outcome [12] 426705 0
Knee pain during horizontal hop (visual analogue scale)
Timepoint [12] 426705 0
Immediately following each braced and unbraced condition
Secondary outcome [13] 426706 0
Knee confidence during horizontal hop (visual analogue scale)
Timepoint [13] 426706 0
Immediately following each braced and unbraced condition

Eligibility
Key inclusion criteria
(i) ACL reconstruction surgery 1-8 years ago; (ii) Aged 18-45 years; (iii) A symptomatic ACLR knee (defined as KOOS4 score <80/100)
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) Knee injury/surgery or knee injection in the past 3 months; (ii) Participation in physiotherapy treatment for either knee in the past month; (iii) Routinely wearing a knee brace in the last 3 months (iv) Other injury or health condition affecting the ability to complete functional tasks (e.g. hopping); (v) Existence of any of the following in the ACL reconstructed leg: skin disorders or allergies, swollen/hot/red scars, varicose veins, neurological abnormalities, impaired blood flow or lymphatic drainage, undiagnosed soft tissue swelling; (vi) Currently pregnant; (vii) Unable to understand written and/or spoken English

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomised to determine the order of assessment: braced vs unbraced condition. A randomisation schedule will be generated by a secure randomisation service established independently to the research team (concealed allocation). The randomisation schedule for each participant will be maintained centrally by La Trobe University (REDCap) and revealed to an unblinded member of the research team who will communicate group allocation to the participant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Cross-over design. 1:1 randomisation ratio (computerised sequence generation) to determine order of brace vs unbraced condition.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Changes in functional, biomechanical and patient-reported outcomes between conditions will be compared using appropriate statistical tests depending on statistical assumptions being met.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
21
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 314733 0
Government body
Name [1] 314733 0
National Health and Medical Research Council
Country [1] 314733 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
La Trobe University, Kingsbury Drive, Bundoora, Victoria 3086, Australia
Country
Australia
Secondary sponsor category [1] 316710 0
None
Name [1] 316710 0
Address [1] 316710 0
Country [1] 316710 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313743 0
La Trobe University Human Research Ethics Committee
Ethics committee address [1] 313743 0
Kingsbury Drive, Bundoora, Victoria 3086
Ethics committee country [1] 313743 0
Australia
Date submitted for ethics approval [1] 313743 0
23/06/2023
Approval date [1] 313743 0
04/09/2023
Ethics approval number [1] 313743 0
HEC23249

Summary
Brief summary
The primary aim of this pilot cross-over RCT is to estimate the immediate-effects of the knee brace. Together with a feasibility evaluation of a 6-week intervention with the knee brace (separate trial registration), this pilot study will inform a future full-scale RCT.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129210 0
Dr Adam Culvenor
Address 129210 0
Health Science 3, La Trobe University, Kingsbury Drive, Bundoora, Victoria 3086, Australia
Country 129210 0
Australia
Phone 129210 0
+61 3 9479 5116
Fax 129210 0
Email 129210 0
[email protected]
Contact person for public queries
Name 129211 0
Dr Adam Culvenor
Address 129211 0
Health Science 3, La Trobe University, Kingsbury Drive, Bundoora, Victoria 3086, Australia
Country 129211 0
Australia
Phone 129211 0
+61 3 9479 5116
Fax 129211 0
Email 129211 0
[email protected]
Contact person for scientific queries
Name 129212 0
Dr Adam Culvenor
Address 129212 0
Health Science 3, La Trobe University, Kingsbury Drive, Bundoora, Victoria 3086, Australia
Country 129212 0
Australia
Phone 129212 0
+61 3 9479 5116
Fax 129212 0
Email 129212 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
We have not planned to share individual participant data at this stage.


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.