protocolSection identificationModule nctId: NCT06305689, orgStudyIdInfo id: 79144, briefTitle: Defining Treatment Outcomes and Genetic Architecture in Idiopathic Toe Walking*, acronym: ITW, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Shriners Hospitals for Children, class: OTHER, descriptionModule briefSummary: To compare and contrast the clinical, gait and parent-reported outcomes following either non-operative (casting) or operative treatment for children with idiopathic toe walking (ITW) and determine whether there are specific genes associated with ITW., conditionsModule conditions: Idiopathic Toe Walking, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: Surgery, interventions name: Serial Casting, outcomesModule primaryOutcomes measure: Gait parameters: Velocity, primaryOutcomes measure: Gait Paremeters:Stride Length (m), primaryOutcomes measure: Three dimensional Gait Analysis:Kinematics (degrees), primaryOutcomes measure: Dynamic Motor Control Index during Walking (Walk-DMC), primaryOutcomes measure: Three dimensional Gait Analysis:Kinetics (nm/kg), primaryOutcomes measure: Quantitative Assessment of Toe Walking, primaryOutcomes measure: Pediatric Outcomes Data Collection Instrument, secondaryOutcomes measure: Passive Range of Motion, secondaryOutcomes measure: Muscle Strength, otherOutcomes measure: The Toe Walking Tool, otherOutcomes measure: Selective Motor Control, otherOutcomes measure: Coactivation Tool, otherOutcomes measure: Bruininks-Oseretsky Test of Motor Proficiency (BOT-2), otherOutcomes measure: Genomics, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Shriners Hospitals for Children, status: RECRUITING, city: Sacramento, state: California, zip: 95817, country: United States, contacts name: Vincent Basas, role: CONTACT, phone: 916-453-2132, email: vincent.basas@shrinenet.org, contacts name: Jon R Davids, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.58157, lon: -121.4944, locations facility: Shriners Hospitals for Children, status: RECRUITING, city: Chicago, state: Illinois, zip: 60707, country: United States, contacts name: Ann Flanagan, role: CONTACT, phone: 773-622-5400, email: aflanagan@shrinenet.org, contacts name: Kelsey Davidson, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.85003, lon: -87.65005, locations facility: Shriners Hospitals for Children, status: RECRUITING, city: Lexington, state: Kentucky, zip: 40508, country: United States, contacts name: Daniella Hudgins, role: CONTACT, phone: 859-268-5772, email: Daniella.Hudgins@shrinenent.org, contacts name: Rebekah Leet, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.98869, lon: -84.47772, locations facility: Shriners Hospitals for Children, status: RECRUITING, city: Portland, state: Oregon, zip: 97239, country: United States, contacts name: Paige Lemhouse, role: CONTACT, phone: 971-544-3377, email: plemhouse@shrinenet.org, contacts name: Jeremy Bauer, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Susan Sienko, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 45.52345, lon: -122.67621, locations facility: Shriners Hospitals for Children, status: RECRUITING, city: Philadelphia, state: Pennsylvania, zip: 19140, country: United States, contacts name: Natalie Williams, role: CONTACT, phone: 215-430-4248, email: Natalie.Wiliams@shrinenet.org, contacts name: Sean Waldron, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.95233, lon: -75.16379, locations facility: Shriners Hospitals for Children, status: RECRUITING, city: Greenville, state: South Carolina, zip: 29605, country: United States, contacts name: Brittney Southerland, role: CONTACT, phone: 864-255-7955, email: Brittney.Southerland@shrinenet.org, contacts name: Lauren Hyer, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: David Westberry, MD, role: SUB_INVESTIGATOR, geoPoint lat: 34.85262, lon: -82.39401, locations facility: Shriners Hospitals for Children, status: RECRUITING, city: Salt Lake City, state: Utah, zip: 84103, country: United States, contacts name: Lisa Certer, role: CONTACT, phone: 801-536-3807, email: Lcarter@shrinenet.org, contacts name: Kristin Carroll, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Bruce MacWilliams, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 40.76078, lon: -111.89105, locations facility: Shriners Children's Spokane, status: RECRUITING, city: Spokane, state: Washington, zip: 99204, country: United States, contacts name: Charlotte Preuschoff, role: CONTACT, phone: 509-623-0427, email: cpreuschoff@shrinenet.org, contacts name: Ted Sousa, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.65966, lon: -117.42908, hasResults: False