Physical Recovery During Bracing After Ankle Fracture (Re-BAF)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOdense University Hospital
About this trial
Ankle fractures are among the most common fractures and represent the second most frequent fracture type requiring surgery. Many patients experience long-term pain, stiffness, and reduced ankle function, which substantially limits their physical activity. Even five years after injury, more than a third of patients have not regained their pre-injury activity levels.
Standard treatment typically involves immobilisation using a rigid foot-ankle brace (walker). Although effective in protecting fracture healing, these braces may be overly restrictive, contributing to ankle stiffness, swelling, delayed physical recovery and return to daily activities, and reduced quality of life. Patients increasingly express a preference for lighter, movement-permitting ankle supports, such as minimal ankle stirrups. Recent evidence suggests that braces and elastic bands that allow more ankle movement than walkers may enhance faster recovery without increasing complications.
However, high quality evidence is necessary for more robust conclusions. The Scandinavian Bracing after Ankle Fracture (BAF) multicentre randomised controlled trial (NCT07163091) therefore investigates whether an ankle stirrup is non-inferior to a standard walker with respect to patient-reported ankle pain and function, measured by the Manchester-Oxford Foot Questionnaire (MOXFQ) three months after ankle fracture. The primary hypothesis is that ankle stirrups better align with patients' preferences for less restrictive bracing while providing sufficient stability during fracture healing. Secondarily, ankle stirrups may promote faster recovery and physical activity.
The Re-BAF trial is nested within a larger multicentre non-inferiority trial (Bracing after Ankle Fracture \[BAF\], ClinicalTrials.gov ID: NCT07163091), aiming to investigate whether an ankle stirrup is non-inferior to a standard foot-ankle brace in improving patient-reported foot and ankle function, as measured by the Manchester-Oxford Foot Questionnaire (\[MOXFQ\], primary BAF outcome) after ankle fracture.
The aim of the Re-BAF trial is to investigate whether ankle stirrups are superior to standard foot-ankle braces in improving physical activity, assessed using objectively measured thigh-worn accelerometry from baseline (i.e. randomisation) to 12-week follow-up. We hypothesize that early and continuous movement during rehabilitation, enabled by an ankle stirrup, is superior in improving physical activity compared with a foot-ankle brace, without compromising fracture healing.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years or older
Surgically or non-surgically treated ankle fracture
Disqualifiers
Pathological fractures
Open fractures (skin perforation)
Prolonged need for immobilisation (e.g. non-union or insufficient wound healing)
Non-weight bearing treatment
Trial design
Design model
Parallel
Treatments tested in this trial
Ankle stirrup
Other interventionFour weeks of weight-bearing as tolerated using an ankle stirrup
Foot-ankle brace
Other interventionFour weeks of weight-bearing as tolerated using a foot-ankle brace (walker)
Treatment groups
280 Participants
are divided into 2 treatment groupsGroup A: Ankle stirrupExperimental treatment 1 intervention
Group B: Foot-ankle brace (walker)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Daily SENS Motion® accelerometer counts as a measure of daily physical activity during the first 12 weeks following ankle fracture
From baseline (randomisation) until 12 weeks post-fracture, participants will continuously wear a thigh-mounted SENS Motion® accelerometer, a GDPR-compliant medical-grade sensor, to objectively assess physical activity and sleep. The SENS Motion accelerometer is a validated device for use in both younger and older orthopaedic populations. It continuously measures total physical activity (expressed as accelerometer counts per day), time spent resting, standing, and being physically active (including walking, running, and cycling), number of steps, movement intensity, nocturnal activity, and sleep duration. The primary endpoint is the between-group difference in physical activity (accelerometer counts) from baseline (randomisation) to 6 and 12 weeks (primary) post-fracture.
Time frame
From baseline (randomisation) to 12 weeks post-fracture.Secondary outcomes
1
Weekly minutes of moderate-to-vigorous-intensity physical activity (MVPA) in the first 12 weeks following ankle fracture
Between-group differences in weekly minutes of moderate-to-vigorous physical activity (MVPA), derived from accelerometer-based activity measurements.
Time frame
From baseline (randomisation) to 6 weeks and 12 weeks post-fracture2
Patient-reported physical activity during the first 12 weeks post-fracture
Between-group differences in self-reported physical activity level will be assessed using the short-form International Physical Activity Questionnaire (IPAQ-SF). The IPAQ-SF assesses self-reported physical activity over the previous seven days and summarises walking, moderate-intensity activity, vigorous-intensity activity, and sitting time into a single score expressed as metabolic equivalent minutes per week (MET-min/week). This summary score is subsequently used to classify patients into one of three physical activity levels: low, moderate, or high. Only this categorical classification will be used as the outcome measure. The questionnaire will be distributed electronically via e-Boks at baseline (randomisation) and at 6 and 12 weeks post-fracture, alongside the PROMs from the BAF trial, within which Re-BAF is nested.
Time frame
Between-group differences are evaluated from baseline (randomisation) to 6 weeks and 12 weeks post-fracture3
Patient-reported weekly pain during the first 12 weeks post-fracture
Between-group differences in patient-reported pain intensity will be assessed using the Numeric Rating Scale (NRS). The NRS is an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain), on which patients report their average pain intensity over the past week. Assessments will be collected weekly via an app-based survey.
Time frame
Between-group differences over time from baseline (randomisation) to 12 weeks post-fracture will be analysed using mixed-effects models with repeated weekly measurements, with results reported at 6 and 12 weeks.4
Patient-reported weekly analgesic use during the first 12 weeks post-fracture
Between-group differences in patient-reported analgesic use will be assessed using a single-item measure capturing the number of days (0-7) on which analgesics were taken during the previous 7 days. Assessments will be collected weekly via an app-based survey.
Time frame
Between-group differences over time from baseline (randomisation) to 12 weeks post-fracture will be analysed using mixed-effects models with repeated weekly measurements, with results reported at 6 and 12 weeks.Other outcomes
1
Daily SENS Motion® accelerometer counts as a measure of daily physical activity at longer-term follow-up (12-22 weeks post-fracture)
From week 12 and until battery is depleted (approximately 22 weeks post-fracture), participants will continuously wear a thigh-mounted SENS Motion® accelerometer, a GDPR-compliant medical-grade sensor, to objectively assess physical activity and sleep. The SENS Motion accelerometer is a validated device for use in both younger and older orthopaedic populations. It continuously measures total physical activity (expressed as accelerometer counts per day), time spent resting, standing, and being physically active (including walking, running, and cycling), number of steps, movement intensity, nocturnal activity, and sleep duration. Secondary outcomes include between-group differences of daily accelerometer counts from baseline (randomisation) to 6 weeks (bracing period) and to 22 weeks (subacute recovery phase) post-fracture.
Time frame
From 12 to 22 weeks post-fracture.2
Adherence to the WHO Physical Activity Guidelines
Between-group differences in the proportion of participants adhering to the World Health Organization (WHO) physical activity guidelines, determined using objectively measured accelerometer data (daily/weekly accelerometer counts)
Time frame
From baseline (randomisation) to 6 weeks, 12 weeks, and 22 weeks post-fracture.3
Weekly minutes of moderate-to-vigorous physical activity (MVPA) at longer-term follow-up (12-22 weeks post-fracture)
Between-group differences in weekly minutes of moderate-to-vigorous physical activity (MVPA), derived from accelerometer-based activity measurements.
Time frame
From 12 to 22 weeks post-fracture.4
Sleep efficiency objectively measured using SENS Motion® accelerometer data at shorter-term (<12 weeks) and longer-term (12-22 weeks) post-fracture
Between-group differences in sleep efficiency, assessed using accelerometer-derived measures of nocturnal activity and sleep duration.
Time frame
From baseline (randomisation) to 6 weeks, 12 weeks, and 22 weeks post-fracture.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Odense University Hospital
Lead sponsor
Aarhus University Hospital
Collaborator
Zealand University Hospital
Collaborator
Sygehus Lillebaelt
Collaborator
Source ClinicalTrials.gov
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