[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626350":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":45,"centralContacts":49,"locations":60,"responsibleParty":74,"collaborators":54,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":54,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":54,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":62,"whyStopped":54,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Shirley Ryan AbilityLab","OTHER",[8,15,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Smart AFO & Home Intervention Training + 5-Azacitidine","EXPERIMENTAL","Participants will receive one Smart AFO device for use during the at-home intervention phase of the study. Participants will be asked to complete and log at least three 30-minute gait training sessions per week at home with the device.\n\nEach session will involve:\n\n1. Walking for 5-10 minutes intervals for 3 trials, with the goal of performing at a 7\u002F10 on the Pictorial Children's Effort Rating Table (PCERT)\n2. Monitoring Heart Rate\n3. Caregiver filling out brief log to track training session details.\n\nA subset of opt-in participants will also be randomized to receive either 5-azacitidine (VIDAZA) or placebo (Mannitol) at midpoint. A registered nurse will deliver a single subcutaneous injection of either AZA or placebo at a dose of 75 mg\u002Fm² to the participants lower abdomen or medial thigh.",[13,14],"Device: Smart Ankle-Foot Orthosis","Drug: 5-Azacitidine",{"label":16,"type":17,"description":11,"interventionNames":18},"Smart AFO & Home Intervention Training + Mannitol (Placebo)","ACTIVE_COMPARATOR",[13,19],"Drug: Placebo",{"label":21,"type":17,"description":22,"interventionNames":23},"Smart AFO & Home Intervention Training","Participants will receive one Smart AFO device for use during the at-home intervention phase of the study. Participants will be asked to complete and log at least three 30-minute gait training sessions per week at home with the device.\n\nEach session will involve:\n\n1. Walking for 5-10 minutes intervals for 3 trials, with the goal of performing at a 7\u002F10 on the Pictorial Children's Effort Rating Table (PCERT)\n2. Monitoring Heart Rate\n3. Caregiver filling out brief log to track training session details.",[13],[25,32,39],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"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.",[21,9,16],[31],"Biomotum Ambulo AFO",{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"DRUG","5-Azacitidine","A subset of opt-in participants will receive a single dose (75mg\u002Fm²) of 5-Azacitidine (AZA), an FDA-approved drug for pediatric oncology. A registered nurse will deliver a single subcutaneous injection at midpoint.",[9],[38],"VIDAZA",{"type":33,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"Placebo","A subset of opt in participants will receive a single dose (75mg\u002Fm²) of Mannitol (placebo). A registered nurse will deliver a single subcutaneous injection at midpoint.",[16],[44],"Mannitol",[46],{"name":47,"affiliation":5,"role":48},"Megan O'Brien, PhD","PRINCIPAL_INVESTIGATOR",[50,56],{"name":51,"role":52,"phone":53,"phoneExt":54,"email":55},"Audrey Wiesner, BS","CONTACT","3122388435",null,"awiesner@sralab.org",{"name":57,"role":52,"phone":58,"phoneExt":54,"email":59},"Jacklyn Stoller, PT, DPT","3122387620","jstoller@sralab.org",[61],{"facility":5,"status":62,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":54},"RECRUITING","Chicago","Illinois","60611","United States","US",{"type":69,"coordinates":70},"Point",[71,72],-87.65005,41.85003,{"lat":72,"lon":71},{"type":48,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":54,"oldOrganization":54},"Megan O'Brien","Associate Director, Technology & Innovation","100626350","phase-2-smart-afo-and-5-azacitidine-to-enhance-mobility-in-children-with-cerebral-palsy-100626350",false,"NCT07434492","Smart AFO and 5-Azacitidine to Enhance Mobility in Children With Cerebral Palsy","Smart Ankle-Foot Orthosis and 5-Azacitidine to Enhance Gait and Community Mobility for Children With Cerebral Palsy","Inclusion Criteria:\n\n* Diagnosis of cerebral palsy classified as Gross Motor Function Classification System (GMFCS) levels I to III\n* Between 8 and 17 years and 8 months of age at the time of enrollment\u002Fconsent. 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.\n* Stable medical condition as determined by the investigator.\n* 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.\n* Height\u002Fweight\u002FBMI between the 5th - 95th percentile of children with cerebral palsy\n* Able to walk for at least 6 minutes (assisted or unassisted)\n* Able to understand and follow simple directions\n* Able to safely fit into a device configuration and tolerate assistance without knee hyperextension while walking\n* At least 20 degrees of passive ankle plantar flexion range of motion\n* Physician approval for participation\n\nExclusion Criteria:\n\n* Knee extension or ankle dorsiflexion contractures greater than 15 degrees\n* Immunodeficiency or hematologic condition\n* Allergy to AZA or mannitol\n* Plans to receive a vaccine within 30 days of the planned AZA or placebo injection to take place at week 5\n* Pregnancy\n* Orthopedic surgery on the lower limbs completed in the prior 12 months\n* New implanted device (e.g., baclofen pump) and\u002For active intrathecal medication titration that may affect muscle spasticity\n* Botulinum toxin treatment within 3 months preceding enrollment unless given approval by the study physician\n* Severe osteoporosis unless given approval by the study physician\n* Current enrollment in a conflicting research study\n* Any other health condition or diagnosis not listed above that may put the participant at risk as determined by the PI or study physician","ALL","8 Years","17 Years",{"count":88,"type":89},60,"ESTIMATED","INTERVENTIONAL",[92],"PHASE2","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.",[95],"Cerebral Palsy",[97],"Pediatric","2026-05-28",{"date":100,"type":101},"2026-06-01","ACTUAL",{"date":98,"type":101},{"date":104,"type":89},"2030-08-31",{"name":5,"class":6},1]