NCT07434492 · Shirley Ryan AbilityLab
Smart AFO and 5-Azacitidine to Enhance Mobility in Children With Cerebral Palsy
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
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.
DRUG
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.
DRUG
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.
Primary outcome measures
6 Minute Walking Test
Time frame: Baseline to Follow-Up, approximately 13 weeks
Participants will complete a 6 minute walking test to measure the total distance they can walk in a 6 minute period.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
Where
- Chicago, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 1, 2026 · Source of record for eligibility and locations