None listed
Conditions
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.
Interventions
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 a
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.
Sponsors
La Trobe University
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
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)
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
Outcome results
None listed