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Public health physiotherapy pathways for anterior cruciate ligament injury

Public health physiotherapy pathways for anterior cruciate ligament injury: a three-arm pilot feasibility randomised controlled trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626000561381
Enrollment
30
Registered
2026-05-04
Start date
2026-05-15
Completion date
2026-11-15
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to determine whether it is feasible to conduct a larger trial evaluating a physiotherapist-led education and supervised exercise-based treatment pathway for people with an anterior cruciate ligament (ACL) injury. The study will compare three approaches: usual care alone, physiotherapist-led education plus usual care, and physiotherapist-led education with supervised exercise plus usual care. The main focus is to assess whether participants can be successfully recruited and retained, whether they adhere to the program, and whether the interventions are acceptable to patients and clinicians. The study will also collect preliminary data on outcomes such as ACL reconstruction surgery rates and patient-reported outcomes to inform the design of a future trial. Ultimately, this research aims to evaluate whether adding education and exercise-based rehabilitation to usual care can reduce the number of people undergoing surgery without negatively affecting patient outcomes.

Interventions

Participants will be randomised (1:1:1) into one of three groups: i) usual care alone; ii) physiotherapist-led education in addition to usual care; and iii) physiotherapist-led education and supervised exercise-based rehabilitation in addition to usual care. Arm 1 - Physiotherapist-led education in addition to usual care Participants will attend a 30-to-45-minute dedicated education session aligning with best-practice recommendations for ACL injury care delivered by a physiotherapist experience

Participants will be randomised (1:1:1) into one of three groups: i) usual care alone; ii) physiotherapist-led education in addition to usual care; and iii) physiotherapist-led education and supervised exercise-based rehabilitation in addition to usual care. Arm 1 - Physiotherapist-led education in addition to usual care Participants will attend a 30-to-45-minute dedicated education session aligning with best-practice recommendations for ACL injury care delivered by a physiotherapist experienced in delivering education content over videoconferencing (Zoom platform) using a standardised slide deck to ensure consistency across participants. The education session will provide evidence for ACL injury management and expected outcomes (emphasising the equivalent outcomes following surgery vs non-surgical rehabilitation) and will include structured, patient-centred discussion on several key topics. These include: understanding ACL injury and typical recovery trajectories (including the non-linear nature of recovery); comparison of treatment options (rehabilitation with or without surgery) and expected timelines for return to activity; the role and structure of progressive rehabilitation; indications for delayed ACL reconstruction (e.g., persistent instability despite adequate rehabilitation or concomitant injury); and the risks and potential complications associated with surgery. The session will also address psychological aspects of recovery (e.g., confidence, fear of re-injury, and expectations), and emphasise that commencing rehabilitation early and trialling exercise-based management does not compromise future surgical outcomes. The education session is interactive and tailored to the participant’s goals, concerns, and stage of recovery, with a focus on empowering patients in their treatment decision-making process and when ACL reconstruction (ACLR) surgery is indicated. This once-off education session will be delivered on top of the usual care pathway provided (see control - ‘usual care’ group). Participants from this group will not be restricted from seeking further treatment. Indeed, the education content will emphasise the importance of trialling exercise-based rehabilitation but not be provided as part of the trial itself. Arm 2 - Physiotherapist-led education and supervised exercise-based rehabilitation in addition to usual care In addition to the ‘usual care’ described below and the dedicated education session described above, participants allocated to this group will be provided with supervised exercise-based rehabilitation at Eastern Health. Participants will undertake a supervised exercise program (based on best available evidence for ACL injury and codesigned with patient-partners and experienced physiotherapists) over a 6-month period delivered by a registered physiotherapist, which will support the transition to an unsupervised program beyond this period. The rehabilitation program targets key domains of ACL recovery, including restoration of knee range of motion, quadriceps and lower-limb muscle strength, neuromuscular control, functional performance, and progressive return to sport and physical activity. Rehabilitation is structured across broad phases reflecting recovery progression: an acute phase (focused on reducing swelling, restoring range of motion, and activating quadriceps), an intermediate phase (focused on improving strength and neuromuscular control and introducing functional tasks), a late phase (focused on achieving high levels of strength and functional symmetry and progressing to sport-specific activities), and a maintenance phase (focused on long-term strength, load management, and injury prevention). Progression through the program is criteria-based rather than time-based and is guided by symptom response (e.g., pain and swelling), movement quality, and functional performance (e.g., strength and hop test symmetry), as determined by the treating physiotherapist. Exercise prescription (type, intensity, and volume) will be individualised but typically includes resistance exercises (e.g., squatting, lunging, and step-based tasks), neuromuscular and balance training, and, in later stages, plyometric and agility-based exercises. The sessions will be conducted weekly for the first 4 weeks, then fortnightly for 8 weeks, and monthly over the last 3 months, for a total of 11 sessions. They will last 30 to 60 minutes, depending upon participant capacity and abilities. To reduce barriers for participation, the physiotherapist-led sessions will be delivered in-person (Box Hill Hospital and/or Maroondah Hospital) or via videoconferencing (Eastern Health telehealth platform - healthdirect) (depending on patient preference and service availability), which have been shown to be equally effective. Appointment location and format (in-person or telehealth) will be determined collaboratively between the participant and the treating physiotherapist to optimise accessibility. Participants will be encouraged to perform the exercise program up to 3 times per week (i.e., some weeks will be 3 home-based sessions and some weeks will be 2 home-based sessions and 1 supervised session). Exercise programs will be prescribed and progressed by a registered physiotherapist using an individualised, staged approach based on participant symptoms and functional capacity. For telehealth and home-based exercise, participants will receive clear verbal and written instructions, including safety guidance and progression criteria. Exercises will be modified as required based on participant response, and participants will be advised to stop exercises and contact the physiotherapist if they experience increased pain, swelling, instability, or other concerning symptoms. Regular monitoring will occur during supervised sessions (in-person or via telehealth), consistent with standard physiotherapy practice. All participants will receive usual care. As per normal clinical care and previous ACL injury RCTs, participants randomised to the “Physiotherapist-led education and supervised exercise-based rehabilitation in addition to usual care” group who experience ACL insufficiency (i.e., ongoing instability and positive clinical testing on ACL deficient tests), and/or subsequently desire ACLR, will be encouraged to seek orthopaedic surgeon opinion as part of their usual care at Eastern Health, and if ACLR is performed, participants will receive usual postoperative care. Given that participants may be enrolled in the study at various time-points following their injury (i.e., there is no specific eligibility criteria regarding time since injury), the education and supervised exercise components will be tailored to the stage of injury and recovery status. This fits into the pragmatic nature of this pilot trial.

Sponsors

La Trobe University
Lead SponsorUniversity

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 40 Years
Healthy volunteers
No

Inclusion criteria

Adults aged 18-40 years referred to orthopaedics at Eastern Health with an imaging confirmed (magnetic resonance imaging) complete ACL rupture.

Exclusion criteria

i) concomitant injury with an indication for surgery (e.g. unstable, displaced meniscal tear [radial, bucket handle, posterolateral corner and/or posterior root tear], large [grade 2 or 3] medial collateral ligament tear, fracture); ii) prior history of ACL rupture on same knee; iii) already wait-listed for ACLR; iv) unable to understand written or spoken English; v) current state/national/international level athletes.

Outcome results

None listed

Source: ANZCTR · Data processed: Jun 21, 2026