None listed
Conditions
Brief summary
The primary aim of this pilot study is to determine the feasibility of wearing an elastic knee brace (Genutrain, Bauerfeind) for 6 weeks on clinical and biomechanical features of early knee osteoarthritis after ACL reconstruction. Together with a pilot cross-over study to estimate the immediate-effects of the 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 randomised to the brace group will receive the brace to wear daily during weight-bearing activities (e.g., walking, running, sports) for 6 weeks. Participants will also receive an educational handout detailing the potential benefit of wearing the elastic
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 randomised to the brace group will receive the brace to wear daily during weight-bearing activities (e.g., walking, running, sports) for 6 weeks. Participants will also receive an educational handout detailing the potential benefit of wearing the elastic knee brace, appropriate brace use and care instructions, and standard product information provided by the manufacturer. No specific restrictions will be applied to other aspects of usual care. Hours each day of brace use will be recorded via paper-based or electronic logbooks (participant preference).
Sponsors
La Trobe University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
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); (iv) Willing to wear an elastic knee brace during weight-bearing activities for 6 weeks
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 commit to the various study assessments over the 6 weeks; (viii) Unable to understand written and/or spoken English
Outcome results
None listed