Smart AFO and 5-Azacitidine to Enhance Mobility in Children With Cerebral Palsy
ConditionCerebral Palsy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age8-17
SponsorShirley Ryan AbilityLab
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Smart Ankle-Foot Orthosis
- 5-Azacitidine
- Placebo
Treatment groups
60 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov