[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100451111":3},{"organization":4,"armGroups":7,"interventions":36,"overallOfficials":63,"centralContacts":67,"locations":73,"responsibleParty":93,"collaborators":95,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":42,"eligibilityCriteria":105,"healthyVolunteers":101,"sex":106,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":42,"studyType":112,"phases":113,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":76,"whyStopped":42,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Northern Arizona University","OTHER",[8,14,18,23,28,32],{"label":9,"type":10,"description":11,"interventionNames":12},"Device resisted gait training (treatment)","EXPERIMENTAL","We will conduct a randomized controlled trial (treatment vs. control) to compare functional outcomes following bilateral targeted ankle resistance training (2 visits\u002Fweek for 12 weeks) vs. dose-matched standard functional gait training.",[13],"Device: Biomotum Spark: Robotic ankle resistance",{"label":15,"type":10,"description":11,"interventionNames":16},"Standard gait training (control)",[17],"Other: Standard gait training",{"label":19,"type":10,"description":20,"interventionNames":21},"Comparison to Standard PT (within subjects control)","We will use a within-subject repeated measures design to compare both gait training groups to matched standard physical therapy.",[22],"Other: Standard physical therapy",{"label":24,"type":10,"description":25,"interventionNames":26},"Device assisted ambulation","We will compare task capacity and performance with adaptive ankle assistance vs. standard ankle foot orthoses and vs. shod (no ankle aid).",[27],"Device: Biomotum Spark: Robotic ankle assistance",{"label":29,"type":10,"description":25,"interventionNames":30},"Passive brace assisted ambulation",[31],"Device: Ankle foot orthosis",{"label":33,"type":10,"description":25,"interventionNames":34},"No ankle aid ambulation",[35],"Other: Standard walking",[37,43,47,51,55,59],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"DEVICE","Biomotum Spark: Robotic ankle assistance","A lightweight assistive wearable ankle robotic device.",[24],null,{"type":38,"name":44,"description":45,"armGroupLabels":46,"otherNames":42},"Biomotum Spark: Robotic ankle resistance","A lightweight resistive wearable ankle robotic device.",[9],{"type":6,"name":48,"description":49,"armGroupLabels":50,"otherNames":42},"Standard gait training","Standard gait training without a device.",[15],{"type":38,"name":52,"description":53,"armGroupLabels":54,"otherNames":42},"Ankle foot orthosis","Standard ankle foot orthosis",[29],{"type":6,"name":56,"description":57,"armGroupLabels":58,"otherNames":42},"Standard physical therapy","Physical therapy without a device.",[19],{"type":6,"name":60,"description":61,"armGroupLabels":62,"otherNames":42},"Standard walking","Walking without a device",[33],[64],{"name":65,"affiliation":5,"role":66},"Zach F Lerner, PhD","PRINCIPAL_INVESTIGATOR",[68],{"name":69,"role":70,"phone":71,"phoneExt":42,"email":72},"Zach Lerner, PhD","CONTACT","928-523-1787","zachary.lerner@nau.edu",[74],{"facility":75,"status":76,"city":77,"state":78,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"Gillette Children's Specialty Healthcare","RECRUITING","Minneapolis","Minnesota","55101","United States","US",{"type":83,"coordinates":84},"Point",[85,86],-93.26384,44.97997,{"lat":86,"lon":85},[89],{"name":90,"role":70,"phone":91,"phoneExt":42,"email":92},"Mike Schwartz, PhD","651-229-3929","MSchwartz@gillettechildrens.com",{"type":94,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR",[96,97],{"name":75,"class":6},{"name":98,"class":6},"University of Washington","100451111","phase-1-augmenting-ankle-plantarflexor-function-in-cerebral-palsy-100451111",false,"NCT05154253","Augmenting Ankle Plantarflexor Function in Cerebral Palsy","Augmenting Ankle Plantarflexor Function and Walking Capacity in Children With Cerebral Palsy","Inclusion Criteria:\n\n* Ages between 8 and 21 years old, inclusive. Diagnosis of CP and a pathological gait pattern caused by ankle dysfunction.\n* Able to understand and follow simple directions (based on parent report, if needed) and walk at least 30 feet with or without a walking aid (Gross Motor Function Classification System (GMFCS) Level I-III).\n* At least 20° of passive plantar-flexion range of motion.\n\nExclusion Criteria:\n\n* Concurrent treatment other than those assigned during the study.\n* A condition other than CP that would affect safe participation.\n* Surgical intervention within 6 months of participation.","ALL","8 Years","21 Years",{"count":110,"type":111},36,"ESTIMATED","INTERVENTIONAL",[114],"PHASE1","The first specific aim is to quantify improvement in ankle muscle function and functional mobility following targeted ankle resistance gait training in ambulatory children with cerebral palsy (CP). The primary hypothesis for the first aim is that targeted ankle resistance training will produce larger improvements in lower-extremity motor control, gait mechanics, and clinical measures of mobility assessed four- and twelve-weeks post intervention compared to standard physical therapy and standard gait training. The second specific aim is to determine the efficacy of adaptive ankle assistance to improve capacity and performance during sustained, high-intensity, and challenging tasks in ambulatory children with CP. The primary hypothesis for the second aim is that adaptive ankle assistance will result in significantly greater capacity and performance during the six-minute-walk-test and graded treadmill and stair stepping protocols compared to walking with ankle foot orthoses and walking with just shoes.",[117],"Cerebral Palsy",[119,120],"Gait","Rehabilitation","2026-02-27",{"date":123,"type":124},"2026-03-03","ACTUAL",{"date":126,"type":124},"2023-02-01",{"date":128,"type":111},"2026-09-25",{"name":5,"class":6},1]