[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603557":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":51,"centralContacts":56,"locations":62,"responsibleParty":310,"collaborators":12,"id":312,"slug":313,"hasResults":314,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":12,"eligibilityCriteria":318,"healthyVolunteers":314,"sex":319,"minAge":320,"maxAge":321,"enrollmentInfo":322,"targetDuration":12,"studyType":325,"phases":326,"briefSummary":328,"conditions":329,"keywords":333,"overallStatus":65,"whyStopped":12,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":353},{"fullName":5,"class":6},"Comeback Mobility Inc","INDUSTRY",[8,13,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Control Group (Standard of Care)","NO_INTERVENTION","Patients in this group receive standard clinical recommendations for weight-bearing progression without the use of digital monitoring tools, specifically six to ten weeks of non-weight-bearing. Axial loading instructions are provided by the treating physician based on clinical examination and radiographic findings. The decision to initiate full weight-bearing is made individually, without objective device-based monitoring. However, patients in this group are provided with Smart Crutch Tips™ that passively monitor gait parameters without providing visual or auditory cues. This allows the collection of adherence data without interfering with the clinical process. Such an approach reflects real-world clinical practice and serves as a comparator for evaluating the effectiveness of personalized strategies.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Controlled Mechanical Stimulation According to AO Guidelines","EXPERIMENTAL","Participants in this group receive recommendations for weight-bearing progression in accordance with AO guidelines (10-20 kg load). Axial loading is monitored in real time using Smart Crutch Tips™, which provide visual and auditory feedback.",[18,19,20],"Device: Smart Crutch Tips™","Procedure: Finite Element Analysis (FEA)","Device: Orthopedic shoes for use during rehabilitation period",{"label":22,"type":15,"description":23,"interventionNames":24},"Personalized Controlled Mechanical Stimulation (FEA)","Participants will receive individualized weight-bearing prescriptions derived from finite element analysis (FEA) of their postoperative CT scan, targeting optimal interfragmentary motion at the fracture site. Smart Crutch Tips™ will provide real-time audio and visual feedback to support adherence to the prescribed loading and activity program.",[18,19,25,26,20],"Behavioral: Iterative walking","Procedure: Lower Limb Rehabilitation Exercise Program",[28,33,38,43,47],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":12},"DEVICE","Smart Crutch Tips™","Smart Crutch Tips™ are sensor-equipped crutch attachments that measure real-time axial loading during ambulation. The devices connect via Bluetooth to a mobile application and deliver auditory and visual feedback to guide patients toward prescribed weight-bearing levels. The devices continuously record loading and step-count data for clinical monitoring and analysis.",[14,22],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":12},"PROCEDURE","Finite Element Analysis (FEA)","Finite Element Analysis (FEA) is performed up to four times postoperatively to generate individualized weight-bearing prescriptions during rehabilitation. Simulations are based on CT scans and include segmentation and biomechanical modeling of the bone-fixator system. Assessments occur at: 8 days (baseline), 6 weeks, 12 weeks, and 15 weeks. Three regions are segmented: fixation system (screws and nail), bone fragments, and fracture gap. Materials: fixator (Titanium Grade 5), bone (mapped into cortical, trabecular, soft tissue, air), and fracture gap (early connective tissue). FEA calculates personalized safe loading based on: (1) Fixator safety (stress \\\u003C 290 MPa), (2) Interfragmentary motion (target: 0.5-2.0 mm), and (3) Strain in the fracture gap (octahedral: 0.001-0.05; hydrostatic: 0.001-0.02), supporting biological healing. Output informs weight-bearing prescriptions and step-count targets, delivered via Smart Crutch Tips™ with real-time fee",[14,22],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":12},"BEHAVIORAL","Iterative walking","Participants will perform iterative walking sessions as part of their rehabilitation program. These sessions will be repeated throughout the day, with a minimum 2-hour rest interval between sessions. Step count will be progressively increased over time, according to the individualized rehabilitation plan.",[22],{"type":34,"name":44,"description":45,"armGroupLabels":46,"otherNames":12},"Lower Limb Rehabilitation Exercise Program","The program consists of a structured set of isometric and dynamic exercises targeting the quadriceps, hamstrings, gluteal muscles, and ankle\u002Ffoot mobility. Exercises are performed in a supine, prone, or seated position, as appropriate, with 2 sets of 5-12 repetitions or sustained holds of 20-30 seconds, progressing gradually according to the rehabilitation plan. All movements are conducted within a pain-free range (not exceeding 4\u002F10 on the VAS scale), with additional hourly ankle mobility work prescribed to reduce swelling and prevent thrombosis.",[22],{"type":29,"name":48,"description":49,"armGroupLabels":50,"otherNames":12},"Orthopedic shoes for use during rehabilitation period","Patients are provided with orthopedic shoes to be worn during the rehabilitation period (up to 6-10 weeks).",[14,22],[52],{"name":53,"affiliation":54,"role":55},"Vaida Glatt, PhD","UT Health","PRINCIPAL_INVESTIGATOR",[57],{"name":58,"role":59,"phone":60,"phoneExt":12,"email":61},"Nataliia POPOVA","CONTACT","+380979137440","nap@comebackmobility.com",[63,77,96,109,122,135,146,160,175,191,203,217,233,245,257,271,282,300],{"facility":64,"status":65,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":12,"geoPoint":12,"contacts":71},"Kyiv City Clinical Hospital No. 1","RECRUITING","Kyiv","Kyiv Oblast","02091","Ukraine","UA",[72,76],{"name":73,"role":59,"phone":74,"phoneExt":12,"email":75},"Oleksandr Martynchuk","+380662272790","blaze_amber@ukr.net",{"name":73,"role":55,"phone":12,"phoneExt":12,"email":12},{"facility":78,"status":65,"city":79,"state":12,"zip":80,"country":69,"countryCode":70,"cosmosGeoPoint":81,"geoPoint":86,"contacts":87},"Municipal Clinical Hospital No. 4 of the Dnipro City Counci","Dnipro","49102",{"type":82,"coordinates":83},"Point",[84,85],35.04066,48.46664,{"lat":85,"lon":84},[88,92,93],{"name":89,"role":59,"phone":90,"phoneExt":12,"email":91},"Oleksii Altanets","+380505757354","alexaltan80@gmail.com",{"name":89,"role":55,"phone":12,"phoneExt":12,"email":12},{"name":94,"role":95,"phone":12,"phoneExt":12,"email":12},"Serhii Shcherbak","SUB_INVESTIGATOR",{"facility":97,"status":65,"city":79,"state":12,"zip":12,"country":69,"countryCode":70,"cosmosGeoPoint":98,"geoPoint":100,"contacts":101},"Communal Non-Profit Enterprise \"Regional Family Health Medical Center\" of the Dnipropetrovsk Regional Council",{"type":82,"coordinates":99},[84,85],{"lat":85,"lon":84},[102,106,107],{"name":103,"role":59,"phone":104,"phoneExt":12,"email":105},"Vitalii Kravchenko","+380981779470","Dr.vitalii.kravchenko@gmail.com",{"name":103,"role":55,"phone":12,"phoneExt":12,"email":12},{"name":108,"role":95,"phone":12,"phoneExt":12,"email":12},"Viktor Rokutov",{"facility":110,"status":65,"city":79,"state":12,"zip":12,"country":69,"countryCode":70,"cosmosGeoPoint":111,"geoPoint":113,"contacts":114},"Municipal Non-Profit Enterprise \"City Clinical Hospital No. 16\" of the Dnipro City Council",{"type":82,"coordinates":112},[84,85],{"lat":85,"lon":84},[115,119,120],{"name":116,"role":59,"phone":117,"phoneExt":12,"email":118},"Vasyl Makarov","380675673081","vasylmakarov2010@gmail.com",{"name":116,"role":55,"phone":12,"phoneExt":12,"email":12},{"name":121,"role":95,"phone":12,"phoneExt":12,"email":12},"Valerii Lytvyn",{"facility":123,"status":65,"city":79,"state":12,"zip":12,"country":69,"countryCode":70,"cosmosGeoPoint":124,"geoPoint":126,"contacts":127},"Municipal Non-Profit Enterprise of the Dnipro Regional Council \"Dnipro Regional Clinical Hospital named after Mechnikov\"",{"type":82,"coordinates":125},[84,85],{"lat":85,"lon":84},[128,132,133],{"name":129,"role":59,"phone":130,"phoneExt":12,"email":131},"Maksym Makarenkov","+380508847654","1798_010@email.dp.ua",{"name":129,"role":55,"phone":12,"phoneExt":12,"email":12},{"name":134,"role":95,"phone":12,"phoneExt":12,"email":12},"Mykyta Tomilin",{"facility":136,"status":65,"city":79,"state":12,"zip":12,"country":69,"countryCode":70,"cosmosGeoPoint":137,"geoPoint":139,"contacts":140},"University Hospital of the Dnipro State Medical University",{"type":82,"coordinates":138},[84,85],{"lat":85,"lon":84},[141,145],{"name":142,"role":59,"phone":143,"phoneExt":12,"email":144},"Andrii Mametiev","+380977800649","mametev75@gmail.com",{"name":142,"role":55,"phone":12,"phoneExt":12,"email":12},{"facility":147,"status":65,"city":148,"state":12,"zip":12,"country":69,"countryCode":70,"cosmosGeoPoint":149,"geoPoint":153,"contacts":154},"Municipal Non-Profit Enterprise \"Ivano-Frankivsk Regional Clinical Hospital of the Ivano-Frankivsk Regional Council\"","Ivano-Frankivsk",{"type":82,"coordinates":150},[151,152],24.71248,48.92312,{"lat":152,"lon":151},[155,159],{"name":156,"role":59,"phone":157,"phoneExt":12,"email":158},"Vadym Sulyma","+380505035279","vadymsulyma11@gmail.com",{"name":156,"role":55,"phone":12,"phoneExt":12,"email":12},{"facility":161,"status":162,"city":66,"state":12,"zip":163,"country":69,"countryCode":70,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"Kyiv City Clinical Hospital No. 17","NOT_YET_RECRUITING","01133",{"type":82,"coordinates":165},[166,167],30.5238,50.45466,{"lat":167,"lon":166},[170,174],{"name":171,"role":59,"phone":172,"phoneExt":12,"email":173},"Maksym Cherniienko","+380633838714","maximchernienko79@gmail.com",{"name":171,"role":55,"phone":12,"phoneExt":12,"email":12},{"facility":176,"status":162,"city":66,"state":12,"zip":177,"country":69,"countryCode":70,"cosmosGeoPoint":178,"geoPoint":180,"contacts":181},"Institute of Traumatology and orthopedics of the national academy of medical sciences of Ukraine","01601",{"type":82,"coordinates":179},[166,167],{"lat":167,"lon":166},[182,186,187,189],{"name":183,"role":59,"phone":184,"phoneExt":12,"email":185},"Oleksii Sulyma","+380675010661","sulymaoleksii@gmail.com",{"name":183,"role":55,"phone":12,"phoneExt":12,"email":12},{"name":188,"role":95,"phone":12,"phoneExt":12,"email":12},"Volodymyr Chornyi",{"name":190,"role":95,"phone":12,"phoneExt":12,"email":12},"Yevhen Kozik",{"facility":192,"status":162,"city":66,"state":12,"zip":193,"country":69,"countryCode":70,"cosmosGeoPoint":194,"geoPoint":196,"contacts":197},"Kyiv City Clinical Hospital No. 12","02000",{"type":82,"coordinates":195},[166,167],{"lat":167,"lon":166},[198,202],{"name":199,"role":59,"phone":200,"phoneExt":12,"email":201},"Taras Kasianchuk","+380966056181","kasyanchuk09@gmail.com",{"name":199,"role":55,"phone":12,"phoneExt":12,"email":12},{"facility":204,"status":162,"city":66,"state":12,"zip":205,"country":69,"countryCode":70,"cosmosGeoPoint":206,"geoPoint":208,"contacts":209},"Kyiv City Clinical Hospital No. 6","03126",{"type":82,"coordinates":207},[166,167],{"lat":167,"lon":166},[210,214,215],{"name":211,"role":59,"phone":212,"phoneExt":12,"email":213},"Oleksandr Lisovyi","+380505390948","liesovoy@icloud.com",{"name":211,"role":55,"phone":12,"phoneExt":12,"email":12},{"name":216,"role":95,"phone":12,"phoneExt":12,"email":12},"Roman Birsa",{"facility":218,"status":65,"city":66,"state":12,"zip":219,"country":69,"countryCode":70,"cosmosGeoPoint":220,"geoPoint":222,"contacts":223},"Kyiv City Clinical Hospital No. 7","03179",{"type":82,"coordinates":221},[166,167],{"lat":167,"lon":166},[224,228,229,231],{"name":225,"role":59,"phone":226,"phoneExt":12,"email":227},"Oleksandr Rozsokha","+380930600000","rassokha.doctor@gmail.com",{"name":225,"role":55,"phone":12,"phoneExt":12,"email":12},{"name":230,"role":95,"phone":12,"phoneExt":12,"email":12},"Serhii Demchuk",{"name":232,"role":95,"phone":12,"phoneExt":12,"email":12},"Oleksandr Polyakov",{"facility":234,"status":162,"city":66,"state":12,"zip":235,"country":69,"countryCode":70,"cosmosGeoPoint":236,"geoPoint":238,"contacts":239},"Kyiv Regional Council \"Kyiv Regional Clinical Hospital\"","04106",{"type":82,"coordinates":237},[166,167],{"lat":167,"lon":166},[240,244],{"name":241,"role":59,"phone":242,"phoneExt":12,"email":243},"Vadym Roienko","+380976430314","vroienko@mail.com",{"name":241,"role":55,"phone":12,"phoneExt":12,"email":12},{"facility":246,"status":65,"city":66,"state":12,"zip":247,"country":69,"countryCode":70,"cosmosGeoPoint":248,"geoPoint":250,"contacts":251},"Kyiv City Clinical Hospital No. 9","04112",{"type":82,"coordinates":249},[166,167],{"lat":167,"lon":166},[252,256],{"name":253,"role":59,"phone":254,"phoneExt":12,"email":255},"Pavlo Honcharuk","+380500569033","pavlo.medicina@gmail.com",{"name":253,"role":55,"phone":12,"phoneExt":12,"email":12},{"facility":258,"status":65,"city":66,"state":12,"zip":259,"country":69,"countryCode":70,"cosmosGeoPoint":260,"geoPoint":262,"contacts":263},"Kyiv City Clinical Hospital No. 8","04201",{"type":82,"coordinates":261},[166,167],{"lat":167,"lon":166},[264,268,269],{"name":265,"role":59,"phone":266,"phoneExt":12,"email":267},"Viktoriia Ladyka","+380634957408","ladika62@ukr.net",{"name":265,"role":55,"phone":12,"phoneExt":12,"email":12},{"name":270,"role":95,"phone":12,"phoneExt":12,"email":12},"Yevhen Drevel",{"facility":272,"status":65,"city":66,"state":12,"zip":12,"country":69,"countryCode":70,"cosmosGeoPoint":273,"geoPoint":275,"contacts":276},"State Institution \"Feofaniya Clinical Hospital of the State Administration of Affairs\"",{"type":82,"coordinates":274},[166,167],{"lat":167,"lon":166},[277,281],{"name":278,"role":59,"phone":279,"phoneExt":12,"email":280},"Ihor Zazirnyi","+38 067 756 3247","zazirny@ukr.net",{"name":278,"role":55,"phone":12,"phoneExt":12,"email":12},{"facility":283,"status":65,"city":284,"state":12,"zip":12,"country":69,"countryCode":70,"cosmosGeoPoint":285,"geoPoint":289,"contacts":290},"Municipal Non-Profit Enterprise \"Lviv Territorial Medical Association\" \"Multidisciplinary Clinical Hospital for Intensive Treatment Methods and Emergency Medical Care\"","Lviv",{"type":82,"coordinates":286},[287,288],24.02324,49.83826,{"lat":288,"lon":287},[291,295,296,298],{"name":292,"role":59,"phone":293,"phoneExt":12,"email":294},"Vasyl Rokyta","+38097616803","vasylrokyta@gmail.com",{"name":292,"role":55,"phone":12,"phoneExt":12,"email":12},{"name":297,"role":95,"phone":12,"phoneExt":12,"email":12},"Ivan Vasyliv",{"name":299,"role":95,"phone":12,"phoneExt":12,"email":12},"Marta Kovalska",{"facility":283,"status":65,"city":284,"state":12,"zip":12,"country":69,"countryCode":70,"cosmosGeoPoint":301,"geoPoint":303,"contacts":304},{"type":82,"coordinates":302},[287,288],{"lat":288,"lon":287},[305,309],{"name":306,"role":59,"phone":307,"phoneExt":12,"email":308},"Yurii Kit","+380667218903","Yura.kit190@gmail.com",{"name":306,"role":55,"phone":12,"phoneExt":12,"email":12},{"type":311,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100603557","smart-crutch-tips-for-guided-weight-bearing-in-patients-recovering-from-extra-articular-distal-tibia-fractures-100603557",false,"NCT07138066","Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Extra-Articular Distal Tibia Fractures","Study of Individual Weight-bearing and Iterative Walking Using \"ComeBack Mobility\" Smart Crutch Tips for Mechanical Stimulation of Extra-articular Distal Tibia Fracture Healing","Inclusion Criteria:\n\n1. Signed informed consent was provided after being fully informed about participation in the study.\n2. Age: 18 to 80 years for both males and females (pre-menopausal).\n3. Body weight between 40 and 120 kg.\n4. Diagnosed with a closed tibial shaft fracture (AO\u002FOTA classification: 43- А1, 43-А2, 43-А3) requiring surgical treatment.\n5. Fracture treated exclusively with plates and\u002For with an intramedullary nail\n6. No diabetes or well-controlled diabetes (HbA1c ≤ 7.0%).\n7. Ability to use crutches without losing balance and medically cleared for partial weight-bearing on the operated limb.\n8. Willingness to adhere to the prescribed weight-bearing protocol using the Smart Crutch Tips™ device.\n9. Enrollment within 48 hours following surgical intervention.\n10. Alcohol consumption (up to 2-3 times per week) within acceptable limits.\n11. Willingness to comply with all study procedures, including follow-up visits at weeks 1, 6, 12, 15, 18, 21, 24, and 36 after surgery.\n12. Patients with fractures extending into the articular surface of the distal tibial epiphysis may be included, provided that the fracture is deemed stable.\"\n\nExclusion Criteria:\n\n1. Presence of open or high-energy fractures, multiple lower-limb fractures, or use of bone grafts.\n2. Fractures classified as 41-A, 41-B, or 42 -A,B according to AO\u002FOTA.\n3. Chronic alcoholism (defined as \\>14 standard drinks per week for men or \\>7 for women).\n4. Presence of metabolic disorders, including uncontrolled thyroid dysfunction, severe renal or hepatic pathology.\n5. Pathological fractures associated with osteoporosis, osteomyelitis, tumors, metastases, or rickets.\n6. Lower-limb contractures with functional impairment of grade II or higher.\n7. Pregnancy or intention to conceive during the study period.\n8. Psychiatric, cognitive, or neurological disorders that may interfere with adherence to the rehabilitation protocol or effective communication with the study team.\n9. Clinically significant heart failure (including chronic or acute, with an ejection fraction \\\u003C40% or with symptoms such as edema, dyspnea at rest, or orthopnea).\n10. Pulmonary insufficiency of any origin, accompanied by chronic hypoxemia (PaO₂ \\\u003C 60 mmHg) or hypercapnia (PaCO₂ \\> 45 mmHg), requiring oxygen support or significantly limiting physical activity.\n11. Clinically significant neurological disorders that may affect motor function, coordination, or physical activity (e.g., stroke with residual deficits, Parkinson's disease, multiple sclerosis, cerebral palsy).\n12. Diagnosed epilepsy or other seizure disorders not fully controlled by medication.\n13. Progressive neurodegenerative diseases (e.g., amyotrophic lateral sclerosis, Huntington's disease, dementia).\n14. Any sensory, balance, or vestibular disorders that may impair safe use of the investigational device.\n15. Participation in another clinical study within the past 6 months that could affect the results of the current study.\n16. Ongoing or planned use of medications known to affect bone healing.","ALL","18 Years","80 Years",{"count":323,"type":324},30,"ESTIMATED","INTERVENTIONAL",[327],"NA","The goal of this clinical trial is to learn whether personalized weight-bearing prescriptions using Smart Crutch Tips™ can improve recovery after surgery for extra-articular distal tibia fractures. The study will also assess how safe and practical this approach is in daily outpatient use.\n\nCan a personalized weight-bearing program based on CT and finite element analysis help the fracture heal faster? Can it help patients return to full weight-bearing sooner? Can it reduce the fear of movement during recovery? Researchers will compare standard rehabilitation, AO Foundation-based recommendations, and personalized weight-bearing programs derived from finite element analysis (FEA) to determine which approach leads to faster healing, earlier mobility, and better outcomes.\n\nParticipants will:\n\nUse Smart Crutch Tips™ during walking for up to 24 weeks; Follow a personalized weight-bearing prescription based on CT scans and biomechanical modeling; Follow a specific walking plan with real-time audio and visual feedback; Attend eight follow-up visits over 36 weeks for clinical exams, x-rays, and CT scans; Complete online questionnaires about pain, activity, and fear of movement.",[330,331,332],"Fracture Healing","Treatment Duration","Distal Tibia Fracture",[334,330,335,336,337,338,339,340,341,342,343],"distal tibia fracture","Controlled Mechanical Loading","Weight-Bearing","Finite Element Analysis","Digital Rehabilitation","Smart Crutch Tips","Bone Union","Rehabilitation Monitoring","Lower Limb Fractures","Biofeedback Device","2026-04-11",{"date":346,"type":347},"2026-04-14","ACTUAL",{"date":349,"type":347},"2025-09-29",{"date":351,"type":324},"2027-01-15",{"name":5,"class":6},18]