Less bulky ankle braces or a stirrup: testing active movement after an ankle fracture

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In people aged 18 and older with an ankle fracture, 280 participants will be randomly assigned to four weeks of weight-bearing as tolerated using either an ankle stirrup or a rigid foot-ankle brace. The study is a superiority trial nested within a larger Scandinavian multicenter program and will focus on daily physical activity and overall physical recovery. Outcomes will include activity levels and functional recovery, with attention to safety and complications. Participants can be treated surgically or non-surgically and will be recruited at Odense University Hospital and collaborating centers in Denmark.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 18 years or older
* Surgically or non-surgically treated ankle fracture

Exclusion Criteria:

* 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

Where it's running

• Odense University Hospital
  Odense, Region Syddanmark, Denmark Recruiting

Study contacts

• Study coordinator: Katrine K Krag-Andersen, PT, MSc
• Email: kanderse@health.sdu.dk
• Phone: +4522466435

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Bracing options after an ankle fracture

  This trial will test whether a less rigid ankle stirrup works as well as a standard walker to reduce pain and improve function three months after an ankle fracture in adults.

  Recruiting at 4 sites Odense University Hospital · Aabenraa and 15 other locations · NCT07163091

• Cardio-Metabolic Clinic care for adults with type 2 diabetes and cardiovascular disease

  This trial tests whether a specialized Cardio-Metabolic Clinic can improve heart function and overall health for adults with type 2 diabetes and cardiovascular disease compared with usual care.

  Recruiting Odense University Hospital · Svendborg · NCT07878325

• Optimised Cardio-Renal Care for CKD and heart disease

  This study tests whether a specialised Cardio-Renal Clinic can improve heart and kidney health and quality of life for adults with chronic kidney disease and cardiovascular disease.

  Recruiting Odense University Hospital · Svendborg · NCT07835828

• See if stopping long-term aspirin is as good as continuing it in older adults with stable ischemic heart disease

  In adults 65 and older with stable ischemic heart disease, this trial tests whether stopping daily low-dose aspirin is not worse than continuing it.

  Recruiting at 2 sites Phase 4 Odense University Hospital · Copenhagen and 1 other locations · NCT07795398

• Normothermic Intraperitoneal Chemotherapy after surgery for elderly and frail women with advanced ovarian cancer

  This study tests whether delivering chemotherapy directly into the abdomen after surgery is safe for older, frail women with advanced ovarian cancer.

  Recruiting Phase 1 Odense University Hospital · Odense · NCT07733505

• Coronary thrombus modification to reduce microvascular damage during STEMI care

  This study tests whether modifying the clot in the heart arteries during primary PCI can lessen microvascular damage and myocardial injury in STEMI patients.

  Recruiting Odense University Hospital · Odense · NCT07646977

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.