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:
NCT07434492
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of cerebral palsy classified as Gross Motor Function Classification System (GMFCS) levels I to III
* Between 8 and 17 years and 8 months of age at the time of enrollment/consent. Participants that will turn 18 during the course of the study will not be included as pausing the at-home protocol until re-consenting is possible could interfere with intervention results.
* Stable medical condition as determined by the investigator.
* Adequate caregiver support to be able to participate in training and assessment sessions for the duration of the study, at the discretion of the PI.
* Height/weight/BMI between the 5th - 95th percentile of children with cerebral palsy
* Able to walk for at least 6 minutes (assisted or unassisted)
* Able to understand and follow simple directions
* Able to safely fit into a device configuration and tolerate assistance without knee hyperextension while walking
* At least 20 degrees of passive ankle plantar flexion range of motion
* Physician approval for participation
Exclusion Criteria:
* Knee extension or ankle dorsiflexion contractures greater than 15 degrees
* Immunodeficiency or hematologic condition
* Allergy to AZA or mannitol
* Plans to receive a vaccine within 30 days of the planned AZA or placebo injection to take place at week 5
* Pregnancy
* Orthopedic surgery on the lower limbs completed in the prior 12 months
* New implanted device (e.g., baclofen pump) and/or active intrathecal medication titration that may affect muscle spasticity
* Botulinum toxin treatment within 3 months preceding enrollment unless given approval by the study physician
* Severe osteoporosis unless given approval by the study physician
* Current enrollment in a conflicting research study
* Any other health condition or diagnosis not listed above that may put the participant at risk as determined by the PI or study physician
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
17 Years
Study:
NCT07434492
Study Brief:
Protocol Section:
NCT07434492