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Found 2 Actively Recruiting clinical trials
Actively Recruiting
Ankle fractures are common injuries that can cause pain and reduce ankle function. This trial evaluates whether an ankle stirrup, a less restrictive brace that allows some ankle movement, is as effective as a standard foot-ankle brace (walker) at reducing pain and improving function three months after an ankle fracture. The study aims to determine if ankle stirrups, which patients tend to prefer, provide enough stability during healing without increasing complications. It also explores if stirrups lead to faster recovery, quicker return to work, and lower costs. This is a pragmatic, multicenter randomized controlled trial conducted in Scandinavian orthopedic departments, including up to 1400 adult patients in various age and sex subgroups. Participants are randomly assigned to either an ankle stirrup or a standard walker brace. Both groups begin weightbearing without restrictions, with the main difference being the type of brace used. The ankle stirrup allows active ankle movement while maintaining stability, whereas the walker immobilizes the ankle during weightbearing. Usual care variations are allowed within the trial. Randomization balances surgically and non-surgically treated patients evenly between groups and centers. Treatment lasts at least 12 weeks, corresponding to the healing period. During the study, participants will be assessed using the Manchester-Oxford Foot Questionnaire to measure pain, function, and social interaction at baseline, 6 weeks, and 12 weeks after the fracture. Researchers will monitor recovery progress, adherence, and any complications. The trial includes subgroup analyses by age and sex. Patient preferences and experiences have informed the trial design, and a former ankle fracture patient is part of the steering committee. Total participation lasts about three months, focusing on outcomes related to ankle function and quality of life.
Actively Recruiting
Sedentary behavior among medical inpatients is closely linked to hospital-associated functional decline, threatening patients' ability to function independently. This study involves 400 patients from hospitals in Copenhagen, Aalborg, Tórshavn, and Nuuk and aims to evaluate a digital intervention designed to reduce sedentary time and increase physical activity during hospital stays. The study uses a stepped-wedge cluster randomized design to assess this approach. The intervention includes digital feedback and nudging directed at both patients and healthcare staff. Physical activity levels are measured using accelerometers, and the digital system provides real-time feedback to encourage patients to be more active while hospitalized. This approach aims to increase patients' physical activity and reduce sedentary behavior during their inpatient stay. Participants will be monitored for their daily average physical activity time from enrollment until the end of their trial participation, which lasts up to seven days. The study collects data on physical activity through accelerometers and tracks how digital nudging influences movement. Safety and ethical considerations are maintained by consulting with medical staff before including patients, ensuring appropriate participation. The total involvement duration depends on each patient's hospital stay, with a focus on short-term activity changes.