Smart AFO and 5-Azacitidine to Enhance Mobility in Children With Cerebral Palsy (NCT07434492) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Smart AFO and 5-Azacitidine to Enhance Mobility in Children With Cerebral Palsy
United States60 participantsStarted 2026-04-20
Plain-language summary
This is an intervention study to investigate the impact of a smart ankle-foot orthosis (AFO) on mobility outcomes in children with Cerebral Palsy. Participants will complete a three phase protocol including 6-weeks of at home training with the smart AFO. Participants will also have the option to participate in a randomized control trial to investigate the impact of 5-Azacitidine combined with the smart AFO to further effect mobility outcomes.
Who can participate
Age range8 Years – 17 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
6 Minute Walking Test
Timeframe: Baseline to Follow-Up, approximately 13 weeks