Physical Recovery During Bracing After Ankle Fracture (Re-BAF)

NCT07521696 | Not Yet Recruiting

• 3 other identifiers: VMK: 250211010.46540/4308-00191B2025 - A6961
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ankle Fracture; Recovery; Physical Activity; Rehabilitation

Keywords

Ankle Fractures; Recovery; Rehabilitation; Braces; Physical activity; Randomized Controlled Trial

Outcome Measures

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.

  From baseline (randomisation) to 12 weeks post-fracture.

Secondary Outcomes (4)

• Weekly minutes of moderate-to-vigorous-intensity physical activity (MVPA) in the first 12 weeks following ankle fracture

  From baseline (randomisation) to 6 weeks and 12 weeks post-fracture

• Patient-reported physical activity during the first 12 weeks post-fracture

  Between-group differences are evaluated from baseline (randomisation) to 6 weeks and 12 weeks post-fracture

• Patient-reported weekly pain during the first 12 weeks post-fracture

  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.

• Patient-reported weekly analgesic use during the first 12 weeks post-fracture

  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 (10)

• Daily SENS Motion® accelerometer counts as a measure of daily physical activity at longer-term follow-up (12-22 weeks post-fracture)

  From 12 to 22 weeks post-fracture.

• Adherence to the WHO Physical Activity Guidelines

  From baseline (randomisation) to 6 weeks, 12 weeks, and 22 weeks post-fracture.

• Weekly minutes of moderate-to-vigorous physical activity (MVPA) at longer-term follow-up (12-22 weeks post-fracture)

  From 12 to 22 weeks post-fracture.

Study Arms (2)

Ankle stirrup

EXPERIMENTAL

Active ankel dorsal and plantar flexion during use of the ankle stirrup

Other: Ankle stirrup

Foot-ankle brace (walker)

ACTIVE COMPARATOR

Immobilisation during use of the foot-ankle brace

Other: Foot-ankle brace

Interventions

Ankle stirrup OTHER

Four weeks of weight-bearing as tolerated using an ankle stirrup

Ankle stirrup

Foot-ankle brace OTHER

Four weeks of weight-bearing as tolerated using a foot-ankle brace (walker)

Foot-ankle brace (walker)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Surgically or non-surgically treated ankle fracture

You may not qualify if:

• Pathological fractures
• Open fractures (skin perforation)
• Prolonged need for immobilisation (e.g. non-union or insufficient wound healing)
• Non-weight bearing treatment
• Inability to adhere to trial procedures (e.g. neuropathy or severe psychiatric disorder)
• Allergy to SENS Motion adhesive patches
• Inability to read or speak Danish
• Uninterest in participating

Sponsors & Collaborators

• Odense University Hospital: lead
• Aarhus University Hospital: collaborator
• Zealand University Hospital: collaborator
• Sygehus Lillebaelt: collaborator

Study Sites (1)

Odense University Hospital

Odense, Region Syddanmark, 5000, Denmark

Location

Related Publications (13)

• Michael Möller CE, Cecilia Mellstrand Navarro, Cecilia Rogmark, Emilia Möller Rydberg, Fabian Burmeister, Hans Juto, Hans-Peter Bögl, Jonas Sundkvist, Mattias Lorentzon, Michael Möller,Mikael Sundfeldt, My von Friesendorff, Olof Wolf, Paul Gerdhem, Morberg, Torsten Backteman, Sebastian Mukka, Simon Blixt Hanne Carlsen. Svenska Frakturregistret Årsrapport 2022. Valentin Experience Regiontryckeriet VGR: Svenska Frakturregistret; 2022.

  BACKGROUND

• Tengberg P.T BM, Gromov K, Kallemose T, Troelsen A. Annual Report Danish Fracture Database 2017.

  BACKGROUND

• Zinder SM, Granata KP, Shultz SJ, Gansneder BM. Ankle bracing and the neuromuscular factors influencing joint stiffness. J Athl Train. 2009 Jul-Aug;44(4):363-9. doi: 10.4085/1062-6050-44.4.363.

  PMID: 19593418 BACKGROUND

• Luna IE, Kehlet H, Wede HR, Hoevsgaard SJ, Aasvang EK. Objectively measured early physical activity after total hip or knee arthroplasty. J Clin Monit Comput. 2019 Jun;33(3):509-522. doi: 10.1007/s10877-018-0185-5. Epub 2018 Jul 23.

  PMID: 30039461 BACKGROUND

• Teylan M, Kantorowski A, Homsy D, Kadri R, Richardson C, Moy M. Physical activity in COPD: Minimal clinically important difference for medical events. Chron Respir Dis. 2019 Jan-Dec;16:1479973118816424. doi: 10.1177/1479973118816424.

  PMID: 30789017 BACKGROUND

• Smeeing DPJ, Houwert RM, Briet JP, Groenwold RHH, Lansink KWW, Leenen LPH, van der Zwaal P, Hoogendoorn JM, van Heijl M, Verleisdonk EJ, Segers MJM, Hietbrink F. Weight-bearing or non-weight-bearing after surgical treatment of ankle fractures: a multicenter randomized controlled trial. Eur J Trauma Emerg Surg. 2020 Feb;46(1):121-130. doi: 10.1007/s00068-018-1016-6. Epub 2018 Sep 24.

  PMID: 30251154 BACKGROUND

• Smeeing DP, Houwert RM, Briet JP, Kelder JC, Segers MJ, Verleisdonk EJ, Leenen LP, Hietbrink F. Weight-bearing and mobilization in the postoperative care of ankle fractures: a systematic review and meta-analysis of randomized controlled trials and cohort studies. PLoS One. 2015 Feb 19;10(2):e0118320. doi: 10.1371/journal.pone.0118320. eCollection 2015.

  PMID: 25695796 BACKGROUND

• McKeown R, Kearney RS, Liew ZH, Ellard DR. Patient experiences of an ankle fracture and the most important factors in their recovery: a qualitative interview study. BMJ Open. 2020 Feb 4;10(2):e033539. doi: 10.1136/bmjopen-2019-033539.

  PMID: 32024789 BACKGROUND

• Appell HJ. Muscular atrophy following immobilisation. A review. Sports Med. 1990 Jul;10(1):42-58. doi: 10.2165/00007256-199010010-00005.

  PMID: 2197699 BACKGROUND

• Ribeiro de Avila V, Bento T, Gomes W, Leitao J, Fortuna de Sousa N. Functional Outcomes and Quality of Life After Ankle Fracture Surgically Treated: A Systematic Review. J Sport Rehabil. 2018 May 1;27(3):274-283. doi: 10.1123/jsr.2016-0199. Epub 2018 Jun 1.

  PMID: 28338395 BACKGROUND

• Kelemework AD, Haile AW, Bayable SD. Assessing the functional outcomes of ankle fracture and its predictive factors following surgical treatment at Addis Ababa burn, emergency, and trauma (AaBET) hospital, Addis Ababa, Ethiopia, 2021: A 5-year retrospective cross-sectional study. Eur J Orthop Surg Traumatol. 2023 Apr;33(3):661-667. doi: 10.1007/s00590-022-03283-2. Epub 2022 Jun 6.

  PMID: 35666308 BACKGROUND

• Shah NH, Sundaram RO, Velusamy A, Braithwaite IJ. Five-year functional outcome analysis of ankle fracture fixation. Injury. 2007 Nov;38(11):1308-12. doi: 10.1016/j.injury.2007.06.002. Epub 2007 Sep 20.

  PMID: 17888434 BACKGROUND

• Somersalo A, Paloneva J, Kautiainen H, Lonnroos E, Heinanen M, Kiviranta I. Incidence of fractures requiring inpatient care. Acta Orthop. 2014 Sep;85(5):525-30. doi: 10.3109/17453674.2014.908340. Epub 2014 Apr 3.

  PMID: 24694275 BACKGROUND

MeSH Terms

Conditions

Ankle Fractures; Motor Activity

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries; Behavior

Study Officials

• Anders Holsgaard-Larsen, PhD

  Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Denmark, and Department of Clinical Research, University of Southern Denmark, Denmark.

  STUDY CHAIR

Central Study Contacts

Katrine K Krag-Andersen, PT, MSc

CONTACT

+4522466435; kanderse@health.sdu.dk

Jonas A Ipsen, PT, PhD

CONTACT

+4523925264; Jonas.Ammundsen.Ipsen@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: April 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Immediately following publication, no end date.
• Access Criteria: Any researcher, affiliated to an established institution

Locations

DK (1)