[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100423945":3},{"organization":4,"armGroups":7,"interventions":109,"overallOfficials":135,"centralContacts":139,"locations":149,"responsibleParty":170,"collaborators":143,"id":173,"slug":143,"hasResults":174,"nctId":175,"briefTitle":176,"officialTitle":176,"acronym":177,"eligibilityCriteria":178,"healthyVolunteers":174,"sex":179,"minAge":180,"maxAge":181,"enrollmentInfo":182,"targetDuration":143,"studyType":185,"phases":186,"briefSummary":188,"conditions":189,"keywords":193,"overallStatus":151,"whyStopped":143,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":206},{"fullName":5,"class":6},"University of Iowa","OTHER",[8,17,21,25,29,33,37,41,45,49,53,57,61,65,69,73,77,81,85,89,93,97,101,105],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1:","EXPERIMENTAL","Testing Order: Clinical AFO, Tall Soft, Tall Firm, Short Soft, Short Firm, NoAFO",[13,14,15,16],"Device: Tall Soft","Device: Tall Firm","Device: Short Soft","Device: Short Firm",{"label":18,"type":10,"description":19,"interventionNames":20},"Arm 2:","Testing Order: Clinical AFO, Tall Soft, Tall Firm, Short Firm, Short Soft, NoAFO",[13,14,15,16],{"label":22,"type":10,"description":23,"interventionNames":24},"Arm 3:","Testing Order: Clinical AFO, Tall Soft, Short Soft, Tall Firm, Short Firm, NoAFO",[13,14,15,16],{"label":26,"type":10,"description":27,"interventionNames":28},"Arm 4:","Testing Order: Clinical AFO, Tall Soft, Short Soft, Short Firm, Tall Firm, NoAFO",[13,14,15,16],{"label":30,"type":10,"description":31,"interventionNames":32},"Arm 5:","Testing Order: Clinical AFO, Tall Soft, Short Firm, Tall Firm, Short Soft, NoAFO",[13,14,15,16],{"label":34,"type":10,"description":35,"interventionNames":36},"Arm 6:","Testing Order: Clinical AFO, Tall Soft, Short Firm, Short Soft, Tall Firm, NoAFO",[13,14,15,16],{"label":38,"type":10,"description":39,"interventionNames":40},"Arm 7:","Testing Order: Clinical AFO, Tall Firm, Tall Soft, Short Soft, Short Firm, NoAFO",[13,14,15,16],{"label":42,"type":10,"description":43,"interventionNames":44},"Arm 8:","Testing Order: Clinical AFO, Tall Firm, Tall Soft, Short Firm, Short Soft, NoAFO",[13,14,15,16],{"label":46,"type":10,"description":47,"interventionNames":48},"Arm 9:","Testing Order: Clinical AFO, Tall Firm, Short Soft, Tall Soft, Short Firm, NoAFO",[13,14,15,16],{"label":50,"type":10,"description":51,"interventionNames":52},"Arm 10:","Testing Order: Clinical AFO, Tall Firm, Short Soft, Short Firm, Tall Soft, NoAFO",[13,14,15,16],{"label":54,"type":10,"description":55,"interventionNames":56},"Arm 11:","Testing Order: Clinical AFO, Tall Firm, Short Firm, Tall Soft, Short Soft, NoAFO",[13,14,15,16],{"label":58,"type":10,"description":59,"interventionNames":60},"Arm 12:","Testing Order: Clinical AFO, Tall Firm, Short Firm, Short Soft, Tall Soft, NoAFO",[13,14,15,16],{"label":62,"type":10,"description":63,"interventionNames":64},"Arm 13:","Testing Order: Clinical AFO, Short Soft, Tall Soft, Short Firm, Tall Firm, NoAFO",[13,14,15,16],{"label":66,"type":10,"description":67,"interventionNames":68},"Arm 14:","Testing Order: Clinical AFO, Short Soft, Tall Soft, Tall Firm, Short Firm, NoAFO",[13,14,15,16],{"label":70,"type":10,"description":71,"interventionNames":72},"Arm 15:","Testing Order: Clinical AFO, Short Soft, Tall Firm, Short Firm, Tall Soft, NoAFO",[13,14,15,16],{"label":74,"type":10,"description":75,"interventionNames":76},"Arm 16:","Testing Order: Clinical AFO, Short Soft, Tall Firm, Tall Soft, Short Firm, NoAFO",[13,14,15,16],{"label":78,"type":10,"description":79,"interventionNames":80},"Arm 17:","Testing Order: Clinical AFO, Short Soft, Short Firm, Tall Soft, Tall Firm, NoAFO",[13,14,15,16],{"label":82,"type":10,"description":83,"interventionNames":84},"Arm 18:","Testing Order: Clinical AFO, Short Soft, Short Firm, Tall Firm, Tall Soft, NoAFO",[13,14,15,16],{"label":86,"type":10,"description":87,"interventionNames":88},"Arm 19:","Testing Order: Clinical AFO, Short Firm, Tall Soft, Tall Firm, Short Soft, NoAFO",[13,14,15,16],{"label":90,"type":10,"description":91,"interventionNames":92},"Arm 20:","Testing Order: Clinical AFO, Short Firm, Tall Soft, Short Soft, Tall Firm, NoAFO",[13,14,15,16],{"label":94,"type":10,"description":95,"interventionNames":96},"Arm 21:","Testing Order: Clinical AFO, Short Firm, Tall Firm, Short Soft, Tall Soft, NoAFO",[13,14,15,16],{"label":98,"type":10,"description":99,"interventionNames":100},"Arm 22:","Testing Order: Clinical AFO, Short Firm, Tall Firm, Tall Soft, Short Soft, NoAFO",[13,14,15,16],{"label":102,"type":10,"description":103,"interventionNames":104},"Arm 23:","Testing Order: Clinical AFO, Short Firm, Short Soft, Tall Firm, Tall Soft, NoAFO",[13,14,15,16],{"label":106,"type":10,"description":107,"interventionNames":108},"Arm 24:","Testing Order: Clinical AFO, Short Firm, Short Soft, Tall Soft, Tall Firm, NoAFO",[13,14,15,16],[110,117,123,129],{"type":111,"name":112,"description":113,"armGroupLabels":114,"otherNames":115},"DEVICE","Tall Soft","Tall heel wedge made of soft foam",[50,54,58,62,66,70,74,78,82,86,9,90,94,98,102,106,18,22,26,30,34,38,42,46],[116],"TS",{"type":111,"name":118,"description":119,"armGroupLabels":120,"otherNames":121},"Tall Firm","Tall heel wedge made of firm foam",[50,54,58,62,66,70,74,78,82,86,9,90,94,98,102,106,18,22,26,30,34,38,42,46],[122],"TF",{"type":111,"name":124,"description":125,"armGroupLabels":126,"otherNames":127},"Short Soft","Short heel wedge made of soft foam",[50,54,58,62,66,70,74,78,82,86,9,90,94,98,102,106,18,22,26,30,34,38,42,46],[128],"SS",{"type":111,"name":130,"description":131,"armGroupLabels":132,"otherNames":133},"Short Firm","Short heel wedge made of firm foam",[50,54,58,62,66,70,74,78,82,86,9,90,94,98,102,106,18,22,26,30,34,38,42,46],[134],"SF",[136],{"name":137,"affiliation":5,"role":138},"Jason M Wilken, PT, PhD","PRINCIPAL_INVESTIGATOR",[140,145],{"name":137,"role":141,"phone":142,"phoneExt":143,"email":144},"CONTACT","319-335-6857",null,"jason-wilken@uiowa.edu",{"name":146,"role":141,"phone":147,"phoneExt":143,"email":148},"Kirsten M Anderson, PhD","319-353-0431","kirsten-m-anderson@uiowa.edu",[150],{"facility":5,"status":151,"city":152,"state":153,"zip":154,"country":155,"cosmosGeoPoint":156,"geoPoint":161,"contacts":162},"RECRUITING","Iowa City","Iowa","52242","United States",{"type":157,"coordinates":158},"Point",[159,160],-91.53017,41.66113,{"lat":160,"lon":159},[163,165,166,167],{"name":137,"role":141,"phone":142,"phoneExt":143,"email":164},"Jason-wilken@uiowa.edu",{"name":146,"role":141,"phone":147,"phoneExt":143,"email":148},{"name":137,"role":138,"phone":143,"phoneExt":143,"email":143},{"name":168,"role":169,"phone":143,"phoneExt":143,"email":143},"Molly Pacha, MS, ATC, LAT","SUB_INVESTIGATOR",{"type":138,"investigatorFullName":171,"investigatorTitle":172,"investigatorAffiliation":5,"oldNameTitle":143,"oldOrganization":143},"Jason Wilken","Associate Professor","100423945",false,"NCT04800484","The Effects of AFO Heel Height and Stiffness on Gait","AFOHeel","GROUP 1 Patient Inclusion criteria\n\n* Ages: 18-70\n* Daily AFO use to address unilateral, below knee functional deficits that result from limb injury or musculoskeletal disease (e.g. fracture, muscle and\u002For nerve injury, ankle arthritis)\n* Greater than 2 weeks using their current AFO\n* Ability to walk 50 feet without use of an assistive device (Cane, crutch, etc.)\n* Ability to walk at a slow to moderate pace\n* AFO fits into traditional footwear\n* Able to read and write in English and provide written informed consent\n\nGROUP 1 Patient Exclusion criteria\n\n* Pain \\> 6\u002F10 while walking during testing or an increase in pain during testing of \\> 2\u002F10.\n* Central Nervous System disorder or disease (e.g. Stroke, Cerebral Palsy, Spinal Cord Injury, or other conditions that result in lower limb spasticity).\n* Disorder or disease that affects peripheral nerve function (e.g. diabetes, Charcot Marie Tooth).\n* Limited contralateral lower limb function due to injury or neurological\u002Fmusculoskeletal disorder.\n* Use of a hinged\u002Farticulating AFO (e.g. Plantar flexion stop, Dorsiflexion assist\u002Fstop, free motion), Charcot Restraint Orthotic Walker (CROW) boot, AFOs that restrict all motion in the ankle and foot.\n* Use of an AFO that crosses the knee (Knee brace)\n* Insufficient space in shoe to accommodate the tallest heel wedge and their AFO\n* Visual or hearing impairments that limit walking ability or could limit the ability to comply with instructions given during testing\n* Pregnancy - Per participant self-report. Due the expected small number of pregnant individuals, and resulting inability to account for its effect on resulting outcomes participants will be withdrawn from the study.\n* Body Mass index \\> 40.\n\nGROUP 2 Patient Inclusion Criteria\n\n* Ages: 18-70\n* Daily AFO use to address below knee functional deficits that result from disease involving the peripheral nervous system (e.g. Charcot Marie Tooth, Multiple Sclerosis, diabetes)\n* Greater than 2 weeks using their current AFO (unilateral or bilateral)\n* Ability to walk 50 feet without use of an assistive device (Cane, crutch, etc.)\n* AFO fits into traditional footwear\n* Ability to walk at a slow to moderate pace\n* Able to read and write in English and provide written informed consent\n\nGROUP 2 Patient Exclusion Criteria\n\n* Pain \\> 6\u002F10 while walking or an increase in pain during testing of \\> 2\u002F10\n* Central Nervous System disorder or disease (e.g. Stroke, Cerebral Palsy, Spinal Cord Injury, or other conditions that result in lower limb spasticity)\n* Limited function due to limb injury (e.g. fracture, muscle and\u002For nerve injury)\n* Use of a hinged\u002Farticulating AFO (e.g. Plantar flexion stop, Dorsiflexion assist\u002Fstop, free motion), Charcot Restraint Orthotic Walker (CROW) boot, AFOs that restrict all motion in the ankle and foot.\n* Use of an AFO that crosses the knee (Knee brace)\n* Insufficient space in shoe to accommodate the tallest heel wedge and their AFO\n* Visual or hearing impairment that limit walking ability or limit the ability to comply with instructions given during testing\n* Pregnancy - Per participant self-report. Due the expected small number of pregnant individuals, and resulting inability to account for its effect on resulting outcomes participants will be withdrawn from the study\n* Body Mass index \\> 40.","ALL","18 Years","70 Years",{"count":183,"type":184},40,"ESTIMATED","INTERVENTIONAL",[187],"NA","The proposed study evaluates the effect of ankle foot orthosis (AFO) heel height and stiffness on the forces and motion of the lower limb during over-ground walking in individuals who use an AFO for daily walking. Previous studies suggest that heel height and stiffness effect limb loading, but these data and the analysis techniques applied are limited. In this study, heel cushions with different height and stiffness's (4 conditions) will be placed in participants shoes and they will walk at controlled and self-selected speeds. Participants will also walk with their AFO as configured prior to enrollment, and with no AFO if possible. The proposed study will provide evidence that can be used by clinicians and researchers to align braces that most effectively improve function during every-day walking.",[190,191,192],"Musculoskeletal Injury","Musculoskeletal Diseases","Peripheral Nervous System Diseases",[194,195,196],"Gait Analysis","Ankle Foot Orthosis","Biomechanics","2025-12-29",{"date":199,"type":200},"2025-12-31","ACTUAL",{"date":202,"type":200},"2019-11-07",{"date":204,"type":184},"2027-01-01",{"name":5,"class":6},1]