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:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07401966
Eligibility Criteria:
Inclusion Criteria:
* Patients aged between 5 and 18 years (inclusive) (Piaget's concrete operational stage to be able to complete the self-assessment questionnaires)
* Patients who underwent amputation before the age of 15 for girls and 16 for boys (average age of completion of lower limb growth)
* Patients who have not undergone surgery on the amputated limb for at least one year (to avoid bias, as any surgery involving incision can cause temporary neuropathic pain unrelated to the amputation)
* Have obtained the signature of the non-objection form by both parents/legal guardians
* Have obtained the child's consent (verbal consent but recorded)
* Be affiliated with a health insurance plan.
Exclusion Criteria:
* Patients who do not speak French
* Patients whose cognitive abilities are insufficient (as determined by a clinician or reported by parents) to be able to complete self-assessment questionnaires
* Patients undergoing chemotherapy (due to transient neuropathic pain)
* Patients who have received chemotherapy and whose side effects have not yet subsided (on a case-by-case basis depending on the chemotherapy used)
* Patients who have received chemotherapy causing neuropathic pain due to this treatment that has not disappeared.
* Patients placed under protective custody.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
18 Years
Study:
NCT07401966
Study Brief:
Protocol Section:
NCT07401966