[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561562":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":34,"centralContacts":38,"locations":47,"responsibleParty":64,"collaborators":67,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":21,"eligibilityCriteria":76,"healthyVolunteers":73,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":21,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":49,"whyStopped":21,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Florida Institute for Human and Machine Cognition","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Real-Time Biofeedback Walking Trials","EXPERIMENTAL","Real-time biofeedback of propulsion and plantar pressure to measure the immediate effects of biofeedback on walking function and gait mechanics.\n\nPermuted block randomization (blocks of 4) will be used to allocate the order of the biofeedback stimulus (plantar pressure-intervention A or propulsion-intervention B).\n\nParticipants will receive both interventions in session 3, but the order will be randomized.",[13,14,15],"Other: Clinical Evaluation","Other: Plantar Pressure Biofeedback Gait Training","Other: Propulsion Biofeedback Gait Training",[17,22,28],{"type":6,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"Clinical Evaluation","A clinical evaluation occurs at the first study session. The clinical evaluation assesses walking function and mobility, lower extremity, sensation, health-related quality of life (HRQoL) and foot function.\n\nSession 2 will be a dynamometer-based evaluation of passive ankle stiffness and a 3-dimensional gait analysis to evaluate baseline biomechanics. During Session 3, real-time biofeedback conditions will be used to measure the immediate effects on walking function.",[9],null,{"type":6,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"Plantar Pressure Biofeedback Gait Training","Participants will complete a 3-dimensional gait evaluation prior to training, after a 6-minute control bout without biofeedback, and following three 6-minute biofeedback training bouts (total 18-minutes). Individualized biofeedback targets will be calculated from each participant's immediate biofeedback session to best minimize plantar pressure whilst maintaining or enhancing propulsion. Audio-visual biofeedback is provided using a screen placed in front of the treadmill and a speaker. For plantar pressure biofeedback, a visual display of a foot with a colored heat map represents the current plantar pressure, in addition to bar graphs representing real-time movement of plantar pressure in specific areas of the foot. A target is provided using the heat map colors of red and target line on the bar graph. Participants are informed that the target is a measurement of the pressure under their foot, and their goal is to decrease pressure to achieve their target",[9],[27],"Intervention A",{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Propulsion Biofeedback Gait Training","Participants will complete a 3-dimensional gait evaluation prior to training, after a 6-minute control bout without biofeedback, and following three 6-minute biofeedback training bouts (total 18-minutes). Individualized biofeedback targets will be calculated from each participant\\'s immediate biofeedback session to best minimize plantar pressure whilst maintaining or enhancing propulsion. Audio-visual biofeedback is provided using a screen placed in front of the treadmill and a speaker. For propulsion biofeedback, a visual display with a marker represents the current propulsion (peak AGRF) and a target provided to modulate propulsion. Participants are informed that the marker is a measurement of how hard they are pushing the ground backward, and their goal is to push-off more to achieve their target.",[9],[33],"Intervention B",[35],{"name":36,"affiliation":5,"role":37},"Nicole K Rendos, PhD","PRINCIPAL_INVESTIGATOR",[39,43],{"name":36,"role":40,"phone":41,"phoneExt":21,"email":42},"CONTACT","(404) 202-4442","nrendos@ihmc.org",{"name":44,"role":40,"phone":45,"phoneExt":21,"email":46},"Craig Tuggle","850-202-4462","ctuggle@ihmc.org",[48],{"facility":5,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"RECRUITING","Pensacola","Florida","32502","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-87.21691,30.42131,{"lat":59,"lon":58},[62],{"name":36,"role":40,"phone":63,"phoneExt":21,"email":21},"850-202-4442",{"type":37,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"Nicole Rendos","Research Scientist",[68],{"name":69,"class":70},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100561562","innovative-multi-variable-biofeedback-for-improving-gait-performance-in-individuals-with-diabetic-peripheral-neuropathy-100561562",false,"NCT06591780","Innovative Multi-Variable Biofeedback for Improving Gait Performance in Individuals With Diabetic Peripheral Neuropathy","Inclusion Criteria:\n\n* Able to walk 10-meters independently without an assistive device\n* Sufficient cardiovascular and musculoskeletal health to walk on a treadmill for 6 minutes at a self-selected speed\n* Diagnosis of diabetes mellitus\n* Diagnosis of diabetic peripheral neuropathy by a physician\n* Foot examination within the past 6 months documenting ambulatory status\n* Physician clearance\n\nExclusion Criteria:\n\n* History of amputation\n* Active ulceration\n* Medial column deformity\n* Severe cognitive impairment (MoCA \\< 10)\n* Severe visual impairment\n* History of Charcot osteoarthropathy\n* History of posterior muscle group lengthening\n* History of lower extremity joint replacement\n* History of lower extremity and\u002For foot surgery affecting walking mechanics\n* Orthopaedic problems of the lower limbs or spine due to other medical conditions (not diabetes or DPN) that limit walking or cause pain during walking\n* Improper footwear for walking and community ambulation\n* Cardiovascular or medical condition affecting ability to walk safely\n* History of unexplained dizziness or fainting in the past 2 months\n* Allergy to adhesive tape or rubbing alcohol","ALL","45 Years","90 Years",{"count":81,"type":82},25,"ESTIMATED","INTERVENTIONAL",[85],"NA","This study aims to collect data to improve gait function in individuals with Diabetic Peripheral Neuropathy (DPN).\n\nThe primary goals are to evaluate:\n\n* Biomechanical mechanisms contributing to abnormal plantar pressure and propulsion during gait in individuals with DPN\n* Biofeedback-induced changes in plantar pressure, propulsion, and biomechanics during gait in individuals with DPN\n\nThe participants will be required to complete\n\n* Questionnaires\n* Clinical examination\n* 3-Dimensional gait analysis on an instrumented treadmill\n* Visual and auditory biofeedback on the participant's propulsion and plantar pressure metrics provided by a projector screen during walking",[88,89],"Diabetic Peripheral Neuropathy","Diabetes Mellitus",[91,92,93],"anterior ground reaction force","biofeedback-induced changes in plantar pressure","diabetic peripheral neuropathy","2026-03-09",{"date":96,"type":97},"2026-03-11","ACTUAL",{"date":99,"type":97},"2025-10-20",{"date":101,"type":82},"2027-06-01",{"name":5,"class":6},1]