Comparing functional bandaging to no immobilization for mild ankle sprains
Multicentre, Randomized, Clinical Trial in Children With Mild Ankle Sprain: Bandaging vs. no Immobilization
This study tests if using a special bandage helps kids aged 5 to 16 recover faster and feel better from mild ankle sprains compared to not using any support.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 5 Years to 16 Years |
| Sex | All |
| Sponsor | Hospital Universitario Infanta Leonor Academic / other |
| Locations | 1 site (Madrid) |
| Trial ID | NCT06222229 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of functional bandaging versus no immobilization in treating mild ankle sprains in children aged 5 to 16 years. Patients with grade I ankle sprains will be randomly assigned to either receive a functional bandage or general measures only, without external support. The study will assess recovery speed, functionality, pain control, and patient satisfaction through follow-up surveys. The trial is conducted across three intermediate-complexity hospitals and has received ethical approval.
Who should consider this trial
Good fit: Ideal candidates are children aged 5 to 16 years diagnosed with a grade I ankle sprain within 72 hours of injury.
Not a fit: Patients with penetrating trauma, associated fractures, or developmental disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery strategies for children with mild ankle sprains, reducing the need for immobilization.
How similar studies have performed: While there is limited research specifically on this approach, similar studies have suggested that non-immobilization strategies can be effective for ankle sprains.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Madrid
- Hospital Universitario Infanta Leonor — Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: Sara SUAREZ-CABEZAS, MD
- Email: ssuarez@salud.madrid.org
- Phone: 0034 661053106
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.