Mild Ankle Sprain Treatment: Functional Bandaging vs. no Immobilization (NCT06222229) | Clinical Trial Compass
UnknownNot Applicable
Mild Ankle Sprain Treatment: Functional Bandaging vs. no Immobilization
Spain150 participantsStarted 2024-01
Plain-language summary
Ankle sprains represent a prevalent pathology among the pediatric population that can result in residual effects when treated incorrectly. However, there is a lack of scientific studies defining the most appropriate therapeutic approach. The hypothesis is that patients treated solely with general measures, without external device support, experience a faster recovery compared to those treated with ankle immobilization. A clinical trial will be carried out by randomly assigning patients to either the functional bandaging group or the control group (general measures only). Prospective follow-up will be carried out by a online survey send by SMS, checking the functionality of the injured ankle using 'the Oxford Ankle Foot Questionnaire for Children (OxAFQ-C)', in addition to pain control and patient satisfaction with the treatment.
Who can participate
Age range
5 Years – 16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of grade I ankle sprain.
* Patients aged between 5 and 16 years.
* Less than 72 hours of evolution.
* Informed consent signed by guardians
Exclusion Criteria:
* Penetrating trauma.
* Associated fracture.
* Consultation more than 72 hours after the trauma.
* Developmental disorders (cerebral palsy, previous gait disorders, autism, etc.).
* Previous or concurrent disease that involves an increased risk of fractures (osteoporosis, bone diseases, etc).
* Previous ankle pathology.
* Impossibility of telephone contact
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage score on the Oxford Ankle and Foot Questionare for Children (OXAFQ-C)
Timeframe: at 5, 14 and 30 days.
2
Intensity of pain
Timeframe: at the emergency department and at 5, 14 and 30 days.