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NCT06189625: PED_HUIL1223

Mild Ankle Sprain Treatment: Functional Bandaging vs. no Immobilization

Completed NA Last updated 17 January 2024
What this trial tests

NA trial testing Control in Mild Ankle Sprain in 113 participants. Completed in 18 May 2022.

Timeline
1 September 2021
Primary endpoint
18 May 2022
18 May 2022

Quick facts

Lead sponsorHospital Universitario Infanta Leonor
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment113
Start date1 September 2021
Primary completion18 May 2022
Estimated completion18 May 2022
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Hospital Universitario Infanta Leonor

Who can join

Adults 5 to 16, any sex, with Mild Ankle Sprain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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. Our 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 telephone, 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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Non-restraint in pediatric ankle sprain: a non-inferiority randomized clinical trial.
    Suarez-Cabezas S, Perez-Moneo B, Cabrerizo Ortiz M, Hortigüela Aparicio M, et al · · 2024 · PMID 39644340 · DOI 10.1007/s00431-024-05904-w
  2. Non-restraint in pediatric ankle sprain: A non-inferiority randomized clinical trial.
    Suarez-Cabezas S, Perez-Moneo B, Ortiz MC, Aparicio MH, et al · · 2024 · DOI 10.21203/rs.3.rs-4717190/v1

Verify or expand the search:

Other trials of Control

Trials testing the same drug.

Other Hospital Universitario Infanta Leonor trials

Trials by the same sponsor.

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Data sources for this page

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