None listed
Conditions
Brief summary
This is a feasibility study aiming to evaluate the usefulness of a weight bearing monitoring sensor in the rehabilitation of patients who have undergone surgical fixation of an ankle fracture. Rehabilitation of such a fracture involves gradual loading of the foot, as the fracture heals. However it is difficult to quantify the amount of loading that actually goes through the foot during the gait cycle. The proposed study is testing the feasibility of using a sensor (Magnes device) to record the weight bearing load during the gait cycle, and can be monitored by the physiotherapist. It is envisaged that the therapist will be able to tailor make a programme of rehabilitation for each patient with accurate load data and monitor patient adherence to the rehabilitation regime. Advances in technology may even allow for the monitoring to be remote through the use of smartphones thus reducing the patient contact time and need to visit the clinic. This being a feasibility study, it will test this technology on 12 patients recruited via the Royal Brisbane Women's Hospital Orthopaedic department. The observations from this feasibility study are going to inform a larger randomised controlled trial testing the clinical and cost efficacy of this technology in the rehabilitation of ankle fractures post-operatively.
Interventions
Patients will be fitted with an Aircast boot in theatre immediately following surgery completion. This is standard practice and patients typically wear this Aircast boot for six weeks post surgery, removing it to shower etc.
The Aircast boot fitted to patients who have consented to participate in this study will be fitted with a monitoring sensor which will record weight bearing characteristics, such that a picture emerges on how the patient uses their (operated) leg and how weight bearing chan
Patients will be fitted with an Aircast boot in theatre immediately following surgery completion. This is standard practice and patients typically wear this Aircast boot for six weeks post surgery, removing it to shower etc. The Aircast boot fitted to patients who have consented to participate in this study will be fitted with a monitoring sensor which will record weight bearing characteristics, such that a picture emerges on how the patient uses their (operated) leg and how weight bearing changes as the rehabilitation progresses. Once the patient has provided informed consent to participate in the study they will be provided with the following: a) An education leaflet detailing care of their fracture and range of exercises at each stage of rehabilitation. b) Information about the device including instructions on how to charge the device periodically. This information leaflet has been specifically designed and produced by the clinicians at RBWH for this study, and has been approved by HREC. c) As part of routine clinical care all patients are offered fortnightly follow-up visits with the physiotherapist as well as routine orthopaedic outpatient reviews at 2, 6 and 12 weeks post operatively. At these orthopaedic outpatient reviews the patient will also be asked to complete two questionnaires - the EQ-5D 5L and the AFORM. Completion of these questionnaires will take approximately 10 minutes. d) Patients who have consented to this study will have the Aircast boot substituted with the Magnes shoe at 6 weeks post operatively if their clinical state allows for the Aircast boot to be removed. In total, participants will be wearing the Aircast boot for the first six week post operatively, and the Magnes NUSHU shoe for the subsequent six weeks. The duration of the their participation in the study will be 12 weeks.
Sponsors
Metro North Health Service
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Are 18 years or older at the time of recruitment. • Have suffered an ankle fracture that can be classified as tibia/fibula, malleolar segment according to the AO Foundation-Orthopaedic Trauma Association (AO-OTA) Fracture and Dislocation Classification Compendium 2018 o infrasyndesmotic fibula injury o trans-syndesmotic fibula fracture, and o supra-syndesmotic fibula injury And, had ankle fracture surgery (fracture types include the fracture types described above and in addition single malleolar, bi-malleolar not extending into the tibial plafond and tri-malleolar with posterior fragment <20%). • Have a Charlson Comorbidity Index score of 4 or less. • Can stand and walk with and without crutches when wearing the Aircast boot at the time of data collection. • Can attend follow-up visits at the RBWH in person.
Exclusion criteria
1. A Charlson Comorbidity Index score 5 or higher 2. Foot or leg size incompatible with available Magnes shoes or Aircast boot 3. Comorbidities: a. concurrent or pre-existing injuries that impair the ability to use the orthosis as intended (e.g. neurological conditions including Multiple Sclerosis, brain injury, spinal cord injury); b. patients with any other disorders involving restriction of mobility, limited ambulation on forearm crutches, or conditions affecting the fracture healing process (e.g. joint disease, neurological disorder, amputation) c. BMI >35kg/m2 4. Require non-standard postoperative care 5. Not able to attend follow-up visits at the RBWH. 6. Have suffered any of the following fracture types: a. talus fractures b. pilon (tibial plafond) fractures c. calcaneal fractures d. stress fractures e. ankle fractures associated with ipsilateral (mid)foot fractures f. bilateral lower limb fractures g. concomitant upper limb fractures or injury h. Posterior malleolus fractures requiring posterior plating i. small and undisplaced fractures that can be managed non-operatively j. trimalleolar fractures with significant posterior involvement that are not suitable for early weight-bearing k. open (compound) fractures or fractures on both lower limbs.
Outcome results
None listed