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Achilles tendon rupture pilot protocol: comparing the feasibility of a criterion-based experimental protocol against standardised care

Achilles tendon rupture rehabilitation: a criterion-based protocol for a feasibility and efficacy parallel randomised pilot study in Adults

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626001141336
Enrollment
32
Registered
2026-09-14
Start date
2026-10-05
Completion date
2027-02-15
Last updated
2026-09-14

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 assess the feasibility of a randomised control trial to examine the efficacy of a novel rehabilitation protocol following acute ATR. The primary objective is to assess study feasibility via a) recruitment, conversion and retention rates, b) patient acceptability of the protocol, exercise prescription and testing, c) adherence to the exercise prescription, and d) adverse events. The secondary objective is to explore treatment effects in a) symptoms and disability related to the ATR, b) force output, c) tendon length and elongation, and d) High-density EMG (HD-EMG) muscle activity between groups at 16 and 26 weeks post-acute injury. Force output will only be tested at weeks 16 and 26, due to the viability of strength testing acute ATR.

Interventions

A criteria based rehabilitation protocol developed as the experimental group intervention. Physical handouts: Participants and physiotherapists will be provided a digital / physical (as per preference) exercise and education sheet for each session. The patient sheet will have all their prescribed exercises and immobilisation requirements. The physiotherapist sheet is a comprehensive version of the patient sheet, with further explanation of how to prescribe all the education and exercises to the

A criteria based rehabilitation protocol developed as the experimental group intervention. Physical handouts: Participants and physiotherapists will be provided a digital / physical (as per preference) exercise and education sheet for each session. The patient sheet will have all their prescribed exercises and immobilisation requirements. The physiotherapist sheet is a comprehensive version of the patient sheet, with further explanation of how to prescribe all the education and exercises to the patient. Intervention descriptions: Each participant of each group will receive 13 fortnightly in-person consultations as part of their intervention. The initial consultation will be 60 minutes and the 12 follow-up consultations will be 30 minutes. All consultations and treatments will be provided by a registered and trained physiotherapist at Centaur Institute (Richmond, Victoria, Australia). The optimised standard care protocol will be the accelerated Achilles rehabilitation protocol by Willits et al., (2010). This protocol is 12 weeks in length, plus additional time on following weaning of the controlled ankle motion (CAM) walker. It is time-based, permitting progression to the next phase once enough time has elapsed. The type of immobilisation device and wedges the participant is initially prescribed will remain the same throughout their involvement. Clinicians will be given guidelines around how to tailor the intervention to the individual participant. The Willits protocol may be found in the supplementary files of the 2010 publication (Willits et al., 2010). The experimental protocol implements a criterion-based approach. Participants will be immobilised in 30-degrees of plantarflexion. This may be in a plaster cast, a CAM-walker with heel wedges, or a 30-degree strut in the VACOped boot (OPED GmbH, Oberlainderm, Germany). If the participant is prescribed shelf wedges, they will instead be given custom made triangular wedges. The first 2 weeks will be non-weight bearing with two forearm crutches to protect the tendon. After 2 weeks, participants will gradually increase weight bearing and reduce wedge height. Exercise interventions include variations of seated and standing single and double leg calf raises, upper and lower body general strength programs, and stationary cycling for cardiovascular health. Graduation from one phase to the next is permitted once criteria are met. The internal Achilles tendon load will be the criterion metric to graduate to the next phase. This load is calculated via a custom-made calculator. It considers Achilles tendon load (L), total body mass (TBM), shank mass (SM), the external mass (E), Achilles tendon moment arm (ATMA), external moment arm (EMA), a maximal voluntary isometric contraction (MVIC) adjustment, an Achilles tendon displacement adjustment (AM), and a cosine adjustment to the external moment arm (cos(theta)) (Byron et al., 2026). The equation below shows the process to calculate an external mass to achieve a pre-specified Achilles tendon load. When a participant is able to consistently lift the external mass required to reach a pre-specified Achilles tendon load, they may then progress to the next phase. E=(L×TBM×((AM×MVIC×ATMA)/(EMA×cos(theta))))-SM A simplified version of the protocol is shown below. The intervention criteria have built in contingency alterations based on participants that are delayed in meeting the progression criteria. Delayed patients will be kept in higher wedges, restricted weight bearing, and a step-to pattern for longer. Adherence: Behavioral change strategies will be suggested and discussed in both groups to assist with exercise completion and protocol adherence. The key strategy for protocol adherence is regular appointments with the treating physiotherapist. It is expected that face to face meetings and tailored modifications of the program will assist with maintaining close program adherence (Bishop et al., 2015; Chester et al., 2023; Room et al., 2021; Teo et al., 2022). Suggested behavioural change strategies include scheduling and timing of exercises, building the program into a daily planner, keeping a personal diary of exercises completed, and setting electronic calendar alerts (Chester et al., 2023; Cinthuja et al., 2022). During fortnightly in-person sessions, physiotherapists will also provide feedback on exercise technique. Participants find value and reassurance in feedback, which may increase adherence (Bishop et al., 2015; Chester et al., 2023; Jónsdóttir et al., 2023). Fidelity: The intervention fidelity will be monitored at regular intervals (every 10-13 sessions) by the chief investigator (PM). The chief investigator will not be involved in data collection or analysis, but will be involved in experimental group intervention delivery. Physiotherapists delivering the treatment will be provided feedback and strategies to improve fidelity as required. All physiotherapists will be provided a script for each appointment with their patients. Patient consent for review of the appointment script and clinician notes will be sought and analysed to measure delivery fidelity. Observation of at least one session of each participant by the chief investigator.

Sponsors

Monash University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Acute unilateral Achilles tendon rupture 2. Aged 18 or older 3. Was seen and immobilised in a camwalker and wedges at 30° of PF, or in a plaster cast at 30°PF within 48 hours of injury (Carta 24 hours) 4. Instructed to remain non weight-bear for the first 14 days after injury and immobilisation 5. Made contact with the primary investigator for the feasibility trial within 14 days of injury, as per the UKSTAR trial (Costa et al., 2020) 6. Must start treatment within the study within seven days of recruitment, 14 to 21 days since injury

Exclusion criteria

1. Prior Achilles tendon rupture (ATR) on the same side 2. Calcaneal avulsion fracture (extra-articular, tongue-type intra-articular, depression-type intra-articular fractures) confirmed on x-ray in A&E/ED 3. Sonographic classification type 4, a proximal musculotendinous junction tear 4. Sonographic classification type 5, a tendon rupture of the distal insertion 5. A traumatic incident that resulted in the ATR as well as other injuries that are more severe than the ATR at the discretion of the research team (i.e. motor vehicle accident tibia fracture) 6. Any musculoskeletal or neurological condition that would likely mean the intervention cannot be conducted with adequate feasibility due to poor premorbid calf or Achilles tendon function, at the discretion of the research team (i.e. Stroke, multiple sclerosis (MS), spinal cord injury (SCI), cerebral palsy (CP), premorbid contracture of the gastrocnemius) 7. Prescribed a plaster cast for greater than 14 days (this will extend them beyond the non-weight-bear period of our study and no longer be eligible).

Outcome results

None listed

Source: ANZCTR · Data processed: Sep 19, 2026