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Smart AFO and 5-Azacitidine to Enhance Mobility in Children With Cerebral Palsy
Sponsor: Shirley Ryan AbilityLab
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.
Official title: Smart Ankle-Foot Orthosis and 5-Azacitidine to Enhance Gait and Community Mobility for Children With Cerebral Palsy
Key Details
Gender
All
Age Range
8 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-03-01
Completion Date
2030-08-31
Last Updated
2026-02-25
Healthy Volunteers
No
Conditions
Interventions
Smart Ankle-Foot Orthosis
The Biomotum Ambulo is an adjustable smart AFO device featuring two adjustable spring settings and provides real-time biofeedback using footplate sensors and progressive goal parameters based on individual gait.
5-Azacitidine
A subset of opt-in participants will receive a single dose (75mg/m²) of 5-Azacitidine (AZA), an FDA-approved drug for pediatric oncology. A registered nurse will deliver a single subcutaneous injection at midpoint.
Placebo
A subset of opt in participants will receive a single dose (75mg/m²) of Mannitol (placebo). A registered nurse will deliver a single subcutaneous injection at midpoint.
Locations (1)
Shirley Ryan AbilityLab
Chicago, Illinois, United States