Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-25 @ 3:39 AM
NCT ID:
NCT03198702
Eligibility Criteria:
Inclusion Criteria:
* Male and female babies with unilateral OBPP
* Age between 10 and 11 months
* Presenting one of 2 risk factors for posterior subluxation of the humeral head (10° less passive external ROM of the affected shoulder compared with the contralateral shoulder and/or a score strictly less than 6 on the AMS for shoulder external rotation and abduction, elbow flexion or supination)
* Signature of the consent form by (the) parent(s) over the age of majority
Exclusion Criteria:
* Bilateral OBPP
* Microsurgery or secondary muscle surgery planned between 12 and 18 months of age
* Contraindications to the use of botulinum toxin
* Contraindications to MRI
* MRI not possible in the Paediatric Day Hospital setting because of contraindications to the sedation protocol or due to organisational constraints
* Parents inapt to provide consent for the participation of their child
* Parents under the age of 18 years
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Months
Maximum Age:
11 Months
Study:
NCT03198702
Study Brief:
Protocol Section:
NCT03198702