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:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2025-12-24 @ 11:59 AM
NCT ID:
NCT06912061
Eligibility Criteria:
Inclusion Criteria:
* Age: 5-16 years
* Consent from parents/guardians
* Indication for Achilles tendon lengthening (toe walking, spasticity), both unilateral and bilateral:
* Equinus foot with dorsiflexion ≤ 0 degrees with the knee extended and the heel in neutral position.
* Symptomatic equinus foot, meaning a foot position causing pain, discomfort, increased fatigue, etc.
Exclusion Criteria:
* Unwillingness to participate, lack of consent
* Previous surgical Achilles tendon lengthening, e.g., for clubfoot
* Received BoNT-a injection in the triceps surae within the last 6 months
* Contracture in the ankle joint, i.e., equinus position not due to a tight Achilles tendon
* Positive Silfverskiöld test and dorsiflexion \> 5 degrees with the knee extended (indicating the need for gastrocnemius recession)
* Concurrent other surgery/other procedures on the same lower extremity, including BoNT-a injection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
16 Years
Study:
NCT06912061
Study Brief:
Protocol Section:
NCT06912061