[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05280639":3,"trial-entities:NCT05280639":122,"trial-summary:NCT05280639":127},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":41,"secondary_outcomes":51,"sex":70,"minimum_age":71,"maximum_age":72,"healthy_volunteers":15,"eligibility_criteria":73,"std_ages":91,"locations":94,"central_contacts":110,"overall_officials":115,"references":120,"see_also_links":121},"NCT05280639","HSR200191","Simplified Post Op Rehabilitation for Ankle and Pilon Fractures","Ankle and Pilon Fracture Post Operative Rehabilitation: A Randomized Control Trial Exploring a Simplified Wooden Block Protocol","RECRUITING","2027-06-01","2026-06","2026-06-08","2022-10-03","University of Virginia","OTHER",false,"The aim of this study is to compare standard post operative rehabilitation with a simplified wooden block stretching protocol that will yield similar results.","Ankle fractures and pilon fractures represent common injuries in orthopedics. These injuries are addressed with re-aligning the bones with surgery, and in some particular cases, they are treated closed reduction and immobilization during healing. The trauma to the ankle as a result of the injury, the prolonged immobilization in a cast or splint and the scar tissue formed during surgery often lead to post injury and post-operative stiffness. Many patients have limited ability to flex the ankle upward (dorsiflexion) following cast or splint removal for these injuries. Physical therapy and rehabilitation represent an an industry-accepted practice for alleviating stiffness and improving function. Currently there are varying studies on the benefits of manual therapy or passive stretch when compared with exercise alone. Neither a supervised exercise program such as formal physical therapy nor a home exercise regiment offer a clear benefit over the other, leading to the question of, if this process can be further simplified to use with the wooden block.\n\nThe main functional complaint of patients is \"stiffness\" or decreased range of motion is in dorsiflexion of the ankle and is cited at approximately 77% of patients following cast or splint removal. This motion is key when walking normally, descending stairs or kneeling and is important to a greater degree when walking up hills , running or rising from a chair. These activities require 10 degrees passive dorsiflexion and 20 degrees on average, respectively. The functional effects of limited ankle dorsiflexion sometimes results in the need for a shoe heel insert or additional surgical procedures to free up the scar in the front of the ankle.\n\nThis randomized control trial aims to analyze two currently-used standards of care for ankle and tibial plafond injuries, simplifying the standard post-operative physical therapy\u002Frehabilitation regiment, which would begin a the time of rigid splint removal, when stretching and range of motion is tolerated. Weight bearing with ambulation is slowly adjusted for the weeks following this. This simplified wooden block protocol ankle exercises focus strictly on ankle dorsiflexion using a wooden block. The investigators aim of doing so is to increase compliance with the exercises and with an improved functional outcome as compared with the standard, more complex exercises and time burdensome options.\n\nThe aim of this study is to compare the standard post injury\u002Fsurgery rehabilitation with this new simplified wooden block stretching protocol and analyze the simplified protocol's effectiveness verses other industry accepted exercises\u002Ftherapy regiments. This study will evaluate pain scores, compliance, range of motion of the ankle and include a Lower Extremity Functionality Score survey, over the course of 3 standard post-operative visits following the subjects injury.",[19,20],"Ankle Fractures","Pilon Fracture",[],"INTERVENTIONAL","TREATMENT",[25],"NA",{"count":27,"type":28},30,"ESTIMATED",[30,36],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DEVICE","Wooden block","Individuals randomized to this group will be given a wooden block at no cost to them and a simplified version of home, self-guided exercises with instructions on how to do the exercises and how often to do so.",[35],"Simplified block protocol",{"type":14,"name":37,"description":38,"armGroupLabels":39},"Formal physical therapy or Home Exercise Program","Individuals randomized to this group will receive the standard formal physical therapy which are sessions run by a physical therapist, usually 2-3 times a week to rehabilitate their ankle OR follow a standardized home exercise program which will be done by yourself with exercise outlined with how they should be performed and how often",[40],"Usual care",[42,46,49],{"measure":43,"description":44,"timeFrame":45},"Ankle Range of Motion (ROM)","maximum plantarflexion and maximum dorsiflexion","2 weeks after surgery",{"measure":47,"description":44,"timeFrame":48},"Ankle ROM","6 weeks after surgery",{"measure":47,"description":44,"timeFrame":50},"6 months after surgery",[52,55,57,61,63,65,68,69],{"measure":53,"description":54,"timeFrame":45},"Self reported subject compliance with exercise program: number of days completed","Comparison of compliance between a full American Academy of Orthopaedic Surgeons (AAOS) home exercise program\u002Fformal physical therapy visits and the simplified ankle dorsiflexion with a wooden block",{"measure":53,"description":56,"timeFrame":48},"Comparison of compliance between a full AAOS home exercise program\u002Fformal physical therapy visits and the simplified ankle dorsiflexion with a wooden block",{"measure":58,"description":59,"timeFrame":60},"Lower Extremity Functional Scale score","Comparison of Lower Extremity Functional Scale score (0 to 80 points) between and within groups. A higher score means better function.","2 weeks after surgery.",{"measure":58,"description":59,"timeFrame":62},"6 weeks after surgery.",{"measure":58,"description":59,"timeFrame":64},"6 months after surgery.",{"measure":66,"description":67,"timeFrame":45},"Pain and ankle Range of Motion","Comparison of analog pain scores (Visual Analog Scale 0-100mm) between and within groups to gauge relationship of pain and ankle range of motion. Lower visual analog scale indicates less pain and higher Range of Motion means better ankle movement.",{"measure":66,"description":67,"timeFrame":48},{"measure":66,"description":67,"timeFrame":64},"ALL","18 Years","65 Years",{"inclusion":74,"exclusion":77,"raw_text":90},[75,76],"Ages 18-65","Surgically treated open or closed fractures of the ankle or tibial plafond",[78,79,80,81,82,83,84,85,86,87,88,89],"Contralateral lower extremity injuries that would limit weight bearing after 6 weeks","Severe injury requiring flap coverage or vascular reconstruction (Gustilo-Anderson Type IIIB and C respectively)","Neurological deficits that would impede ability to stand safely unassisted for home exercise regiment","Desire to participate in formal physical therapy program","Additional injury that would compromise subjects ability to follow either Home Exercise Program","Non ambulatory prior to injury","Previous ankle or tibial plafond injury on ipsilateral extremity","BMI \\> 50","Severe problems maintaining follow up","Previous ankle\u002Ftibial plafond fracture","Prisoners","Neurological impairments that impair balance","Inclusion Criteria:\n\n* Ages 18-65\n* Surgically treated open or closed fractures of the ankle or tibial plafond\n\nExclusion Criteria:\n\n* Contralateral lower extremity injuries that would limit weight bearing after 6 weeks\n* Severe injury requiring flap coverage or vascular reconstruction (Gustilo-Anderson Type IIIB and C respectively)\n* Neurological deficits that would impede ability to stand safely unassisted for home exercise regiment\n* Desire to participate in formal physical therapy program\n* Additional injury that would compromise subjects ability to follow either Home Exercise Program\n* Non ambulatory prior to injury\n* Previous ankle or tibial plafond injury on ipsilateral extremity\n* BMI \\> 50\n* Severe problems maintaining follow up\n* Previous ankle\u002Ftibial plafond fracture\n* Prisoners\n* Neurological impairments that impair balance",[92,93],"ADULT","OLDER_ADULT",[95],{"facility":96,"status":8,"city":97,"state":98,"zip":99,"country":100,"contacts":101,"geoPoint":107},"University of Virginia Medical Center","Charlottesville","Virginia","22908","United States",[102],{"name":103,"role":104,"phone":105,"email":106},"Lori Elder","CONTACT","434-924-8570","LJE5U@uvahealth.org",{"lat":108,"lon":109},38.02931,-78.47668,[111],{"name":112,"role":104,"phone":113,"email":114},"Eric McVey, MEd","434.243.5382","edm9u@hscmail.mcc.virginia.edu",[116],{"name":117,"affiliation":118,"role":119},"Seth Yarboro, MD","University of Virginia Orthopaedic Surgey","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":123,"biomarkers":126},[124,125],"Ankle Fracture","Pilon fracture",[],{"nct_id":4,"found":128,"summary":129,"prompt_version":139},true,{"design":130,"status":131,"heading":132,"summary":133,"follow_up":134,"word_count":135,"commitments":136,"compensation":137,"drugs_mentioned":138},"This interventional study plans to enroll 30 participants. Participants will be randomly assigned to either the wooden block group or the formal physical therapy\u002Fhome exercise program group.","completed","Simplified Rehabilitation for Ankle and Pilon Fractures","This study is looking at new ways to help people recover after surgery for ankle or pilon fractures (a break in the shin bone near the ankle). It compares standard physical therapy or a home exercise program with a simpler approach using a wooden block and self-guided exercises. The goal is to see if the wooden block method can achieve similar results in improving ankle movement. You might be able to join if you are between 18 and 65 years old and have had surgery for an ankle or pilon fracture. The study will measure how well your ankle moves at 2 weeks, 6 weeks, and 6 months after surgery. The current status of this study is unclear.","Your ankle range of motion will be measured at 2 weeks, 6 weeks, and 6 months after surgery.",118,"If you are in the wooden block group, you will receive a wooden block and instructions for home exercises. If you are in the other group, you will either attend formal physical therapy sessions (2-3 times a week) or follow a standardized home exercise program.","Not stated in the trial record.",[32],"v2"]