Status:
RECRUITING
Mild Ankle Sprain Treatment: Functional Bandaging vs. no Immobilization
Lead Sponsor:
Hospital Universitario Infanta Leonor
Conditions:
Primary Disease or Condition Being Studied in the Trial or the Focus of the Study Mild Ankle Sprain
Eligibility:
All Genders
5-16 years
Phase:
NA
Brief 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 m...
Detailed Description
Study Design: A randomized, parallel, open-label, multi-center clinical trial will be conducted at 3 intermediate-complexity hospitals. The study received approval from the center's ethics committee. ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2024
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06222229
Start Date
January 1 2024
End Date
March 1 2024
Last Update
January 24 2024
Active Locations (1)
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1
Hospital Universitario Infanta Leonor
Madrid, Spain, 28031