[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604098":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":32,"locations":42,"responsibleParty":55,"collaborators":24,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":24,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":79,"overallStatus":83,"whyStopped":24,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Thomas Jefferson University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PT Group","EXPERIMENTAL","Initial Protocol (Post-Randomization): Participants will receive foundational instructions like usual care, including:\n\nBinder Use: Guidance on abdominal binder use.\n\nLifting Precautions: Instruction on safe lifting techniques to protect the healing abdominal wall.\n\nGradual Return to Activities: Advice on progressively re-engaging in daily activities.\n\nTailored Physical Therapy Sessions (6 Sessions): Following the initial phase, participants will undergo 6 structured PT sessions. The progression and focus of these sessions will be individualized based on the participant's Oswestry Disability Index (ODI) score and Pelvic Floor Distress Inventory-20 (PFDI-20) score.",[13],"Other: PT Group",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual Care","ACTIVE_COMPARATOR","Protocol: Participants in this group will receive standard post-operative care instructions, which include:\n\nBinder Use: Guidance on the appropriate use of an abdominal binder.\n\nLifting Precautions: Instruction on safe lifting techniques to protect the healing abdominal wall.\n\nGradual Return to Activities: Advice on progressively re-engaging in daily activities.\n\nFollow-up: Participants will continue with usual care (no PT intervention) after the initial 12 weeks until the final assessment at Testing Session 2 (12 weeks post-operatively).",[19],"Other: Usual Care",[21,25],{"type":6,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"Exercise, Manual Therapy, and education",[9],null,{"type":6,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"Education",[15],[29],{"name":30,"affiliation":5,"role":31},"Christopher Keating","PRINCIPAL_INVESTIGATOR",[33,38],{"name":34,"role":35,"phone":36,"phoneExt":24,"email":37},"Christopher Keating, PhD","CONTACT","2155041647","christopher.keating@jefferson.edu",{"name":39,"role":35,"phone":40,"phoneExt":24,"email":41},"Sami Tannouri, MD","215-955-6864","Sami.Tannouri@jefferson.edu",[43],{"facility":5,"status":24,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":24},"Philadelphia","Pennsylvania","19107-5084","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-75.16362,39.95238,{"lat":53,"lon":52},{"type":56,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100604098","the-impact-study-personalized-physical-therapy-for-better-recovery-and-a-stronger-core-after-hernia-surgery-100604098",false,"NCT07145099","The IMPACT Study: Personalized Physical Therapy for Better Recovery and a Stronger Core After Hernia Surgery","The IMPACT Study: A Randomized Controlled Trial of Individualized Management Post Ventral Hernia Repair (VHR) Utilizing Abdominal Core Therapy for Enhanced Recovery and Health Outcomes","IMPACT","Inclusion Criteria:\n\n* Participants must be aged 18-75.\n* Diagnosed clinically or via objective testing by a surgeon with a ventral transverse hernia \\>4 cm and \\\u003C10 cm.\n* Scheduled for elective surgical correction of a non-recurrent, primary or incisional ventral hernia.\n* Independent functional status.\n\nExclusion Criteria:\n\n* Individuals currently receiving or who have received PT within the last 30 days.\n* Individuals currently using an assistive device for ambulation.\n* Individuals diagnosed with a neurologic disorder will be excluded.\n* History of or plan for Botox injection or muscle release related to the hernia.\n* Pregnancy","ALL","18 Years","75 Years",{"count":69,"type":70},100,"ESTIMATED","INTERVENTIONAL",[73],"NA","The goal of this clinical trial is to evaluate the efficacy, safety, and cost-effectiveness of a tailored physical therapy (PT) intervention targeting Abdominal Core Health components in patients recovering from ventral hernia repair. The study focuses on patients aged 18-75 diagnosed with a ventral transverse hernia between 4 cm and 10 cm, scheduled for elective Ventral Hernia Repair (VHR).\n\nThe main questions it aims to answer are:\n\n* Will tailored PT significantly improve abdominal core strength, biomechanical stability, and functional mobility compared to usual care at 3-months post-surgery?\n* Will tailored PT lead to higher patient-reported quality of life and satisfaction scores, with a lower incidence of post-operative complications such as bowel obstruction and pelvic floor dysfunction over a 1-year follow-up?\n* Will tailored PT result in decreased healthcare utilization, leading to overall cost savings or neutrality compared to usual care over the first year after VHR?\n\nResearchers will compare the tailored physical therapy group to a usual care group to see if the tailored intervention leads to significant improvements in clinical efficacy, patient outcomes, and cost-effectiveness.\n\nParticipants will:\n\n* Be randomly assigned to either the Usual Care Group or the PT Group.\n* If in the Usual Care Group, receive standard post-operative instructions for 12 weeks, including guidance on binder use, safe lifting, and gradual return to activities.\n* If in the PT Group, receive foundational post-operative instructions for the first 2 weeks (similar to usual care). Undergo 6 structured and individualized PT sessions over 10 weeks if in the PT Group, with progression based on Oswestry Disability Index (ODI) and Pelvic Floor Distress Inventory-20 (PFDI-20) scores, including Symptom Modulation, Movement Control, Functional Optimization, or Impairment-Based interventions.\n\nParticipants undergo data collection at 2 weeks, 12 weeks, and 1 year post-operation, including imaging, functional mobility tests, pain scales, patient-reported outcomes, physical measurements, and tracking of complications and healthcare utilization. Participate in semi-structured interviews after the 12-week assessment to provide qualitative insights into their experiences and perceived barriers\u002Ffacilitators.",[76,77,78],"Ventral Hernia","Ventral Incisional Hernia","Post Operative Pain",[80,81,82],"Physical Therapy","Rehabilitation","Economic Impact","NOT_YET_RECRUITING","2025-09-02",{"date":86,"type":87},"2025-09-10","ACTUAL",{"date":89,"type":70},"2026-01-01",{"date":91,"type":70},"2028-01-01",{"name":5,"class":6},1]