[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07584707":3,"trial-entities:NCT07584707":112,"trial-summary:NCT07584707":116},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":22,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":52,"secondary_outcomes":69,"sex":73,"minimum_age":74,"maximum_age":75,"healthy_volunteers":76,"eligibility_criteria":77,"std_ages":89,"locations":92,"central_contacts":107,"overall_officials":109,"references":110,"see_also_links":111},"NCT07584707","2403974-1","Investigation of Motorized Lower-limb Prostheses","NOT_YET_RECRUITING","2029-03-15","2026-05","2026-05-13","2026-04-16","Northern Arizona University","OTHER",false,"The goal of this clinical trial is to learn if a motorized prosthesis can improve mobility in individuals with amputation. The main question it aims to answer is:\n\n* Does motorized prosthesis improve ambulation speed, balance, control, or efficiency when performing everyday activities?\n* What problems arise when using a motorized prosthesis? Researchers will compare mobility of the participants when using and not using the motorized prosthesis to see if mobility and\u002For function improves.\n\nParticipants will perform various activities with and without the motorized prosthesis including:\n\n* Walking at a mild incline\u002Fdecline (0°-15°) on treadmill or over-ground\n* Ascending or descending stairs\n* Stand to sit and sit to stand transitions\n* All terrain walking over ground\n* Turning\n* Any combination of the above-mentioned activities","Participants will perform ambulation activities (see list below) while using their prescribed prosthesis or the motorized prosthesis in conjunction with their prescribed passive prosthesis. Each ambulation activity will be tested in four different conditions:\n\n1. Ambulation with their personal (take home) device. This condition acts as a baseline to which the ambulation with the motorized prosthesis can be compared.\n2. Ambulation with the motorized prosthesis in the \"off\" configuration (i.e., no power is applied to the motor). This condition demonstrates the impact of the device when it is unpowered.\n3. Ambulation with the motorized prosthesis in the \"transparent\" configuration (i.e., minimal power is applied to the motor, such that the device behaves as a free hinge). This condition demonstrates the impact of the device when it behaves as a free hinge, similar to the participants personal device.\n4. Ambulation with the motorized prosthesis in the \"powered\" configuration (i.e., substantial electrical power is applied to the motor to replicate the function of the biological joint). This condition assesses the impact of the motorized prosthesis to improve ambulation of the participant.\n\nTrials will take place over-ground and\u002For on a treadmill. Participants will walk for up to 40 minutes. Frequent breaks will be provided between trials and conditions to avoid fatigue and a maximum of 15 minutes of continuous walking will take place between breaks. When deemed necessary by the research staff or participant, crutches, canes, walkers, an overhead support system, or other ambulation or safety aid will be used to minimize the risk of a severe fall.\n\nList of ambulation activities\n\n1. Walking at a mild incline\u002Fdecline (0°-15°) on treadmill or over-ground\n2. Ascending or descending stairs\n3. Stand to sit and sit to stand transitions\n4. All terrain walking over ground\n5. Turning\n6. Any combination of the above-mentioned activities\n\nThe above conditions will be assessed using motion capture techniques in the laboratory environment which will include measures of metabolic energy consumption and muscle activity.\n\nAll terrain walking over ground will take place on campus and include Engineering, Business, and Learning resource Center buildings, the north and south quads, and campus walkways and urban trails. During all terrain walking, the participant will be attended by research personnel that will monitor subject safety.",[18,19,20,21],"Ambulation With the \"Take Home\" or Passive Prosthesis","Ambulation With the Motorized Prosthesis in the \"Off\" Configuration","Ambulation With the Motorized Prosthesis in the \"Transparent\" Condition","Ambulation With the Motorized Prosthesis in the \"Powered\" Condition",[23,24,25,26,27],"motorized prosthesis","ambulation","biomechanics","mobility","amputation","INTERVENTIONAL","TREATMENT",[31],"NA",{"count":33,"type":34},20,"ESTIMATED",[36,46],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":42},"DEVICE","Passive prosthesis","The participant will perform the study protocol with their \"take home\" prosthesis and\u002For another suitable passive prosthesis.",[41],"Experimental Group",[43,44,45],"take home prosthesis","control","baseline",{"type":37,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"Motorized prosthesis","The motorized prosthesis is an experimental device. The device is constructed from plastic and metal. It has motors, sensors, and electronic systems to control the prosthesis to mimic the behavior of a biological joint. The device is determined non-significant risk by the sponsor's Institutional Review Board.",[41],[51],"powered prosthesis",[53,57,60,63,66],{"measure":54,"description":55,"timeFrame":56},"Joint position","Motion capture measurements will be taken to calculate joint position (degrees) of the ankle, knee, hip, and torso. Participant measurements will be averaged per condition to generate a participant average. Participant averages will be pooled to determine an average per condition.","Assessment will be taken on Day 1 (Intervention 1), Day 2 (Intervention 2 - condition 1), Day 3 (Intervention 2 - condition 2), and Day 4 (Intervention 2 - condition 3)",{"measure":58,"description":59,"timeFrame":56},"Joint Velocity","Motion capture will be used to record joint velocity (deg\u002Fs) of the ankle, knee, hip, and torso. Participant measurements will be averaged per condition to generate a participant average. Participant averages will be pooled to determine an average per condition.",{"measure":61,"description":62,"timeFrame":56},"Ground reaction force","The force a participant exerts on the ground (Newtons) will be measured using a force plate. Participant measurements will be averaged per condition to generate a participant average. Participant averages will be pooled to determine an average per condition.",{"measure":64,"description":65,"timeFrame":56},"Muscle Electric Potential","Muscle electric potential will be measured using skin mounted electrodes (surface electromyography) and reported in volts. Participant measurements will be averaged per condition to generate a participant average. Participant averages will be pooled to determine an average per condition.",{"measure":67,"description":68,"timeFrame":56},"Gas uptake and exchange","Oxygen consumption and CO2 production will be measured in L\u002Fs. Participant measurements will be averaged per condition to generate a participant average. Participant averages will be pooled to determine an average per condition.",[70],{"measure":71,"description":72,"timeFrame":56},"User Perception","User perception of the device will be assessed using NASA TLX survey. Participants will assess the device on a scale of 1-10 based on a questionnaire. Participant measurements will be averaged per condition to generate a participant average. Participant averages will be pooled to determine an average per condition.","ALL","18 Years","85 Years",true,{"inclusion":78,"exclusion":84,"raw_text":88},[79,80,81,82,83],"Individuals age 18 to 85 with or without lower-limb amputation","Able to understand and follow simple directions in English based on ability to provide verbal consent","Able to walk at least 30 feet with or without a walking aid","Able to safely fit into a device configuration and tolerate assistance","Individuals with lower-limb amputation must receive physician approval to participate in the study.",[85,86,87],"Any neurological, musculoskeletal (other than lower-limb amputation) or cardiorespiratory injury, health condition (including pregnancy), or diagnosis that would affect the ability to walk as directed for short periods of time.","Participant or caregiver report that the perspective participant's physician has recommended that they not engage in moderate intensity walking exercise.","Subject mass greater than the engineered limit of the device (90 kg or 198 lbs) Note: No exclusions will be made on the basis of race, gender or ethnic background.","Inclusion Criteria:\n\n* Individuals age 18 to 85 with or without lower-limb amputation\n* Able to understand and follow simple directions in English based on ability to provide verbal consent\n* Able to walk at least 30 feet with or without a walking aid\n* Able to safely fit into a device configuration and tolerate assistance\n* Individuals with lower-limb amputation must receive physician approval to participate in the study.\n\nExclusion Criteria:\n\n* Any neurological, musculoskeletal (other than lower-limb amputation) or cardiorespiratory injury, health condition (including pregnancy), or diagnosis that would affect the ability to walk as directed for short periods of time.\n* Participant or caregiver report that the perspective participant's physician has recommended that they not engage in moderate intensity walking exercise.\n* Subject mass greater than the engineered limit of the device (90 kg or 198 lbs) Note: No exclusions will be made on the basis of race, gender or ethnic background.",[90,91],"ADULT","OLDER_ADULT",[93],{"facility":12,"city":94,"state":95,"zip":96,"country":97,"contacts":98,"geoPoint":104},"Flagstaff","Arizona","86001","United States",[99],{"name":100,"role":101,"phone":102,"email":103},"Dante A Archangeli, PhD","CONTACT","928-421-3563","dante.archangeli@nau.edu",{"lat":105,"lon":106},35.19807,-111.65127,[108],{"name":100,"role":101,"phone":102,"email":103},[],[],[],{"nct_id":4,"conditions":113,"biomarkers":115},[114],"Amputation",[],{"nct_id":4,"found":76,"summary":117,"prompt_version":125},{"design":118,"status":119,"heading":6,"summary":120,"follow_up":118,"word_count":121,"commitments":122,"compensation":123,"drugs_mentioned":124},"Not specified.","completed","{\n   \"Investigation of Motorized Lower-limb Prostheses\",\n   \"This study is looking into whether a motorized prosthesis can help people with lower-limb amputations move around better. Researchers want to see if using the motorized prosthesis improves walking speed, balance, control, or how efficiently you move during everyday activities, compared to your usual prosthesis. You would try out different activities like walking on inclines, stairs, and uneven ground, both with your own prosthesis and with the experimental motorized prosthesis. The study will compare how you move in these different situations. The goal is to understand if this new device can improve your mobility and what challenges might come up when using it. We are looking for 20 participants, aged 18 to 85, who can walk at least 30 feet.\",\n  \"design\": \"This is an interventional study involving 20 participants. You will try different conditions of the motorized prosthesis and your own prosthesis.\",\n  \"commitments\": \"You will perform various ambulation activities over four assessment days, walking for up to 40 minutes each day.\",\n  \"compensation\": \"Not stated in the trial record.\",\n  \"follow_up\": \"Assessments will be taken on Day 1, Day 2, Day 3, and Day 4, which are the timeframes for the primary endpoints.\",\n}",198,"Not specified in the trial record.","Not stated in the trial record.",[47],"v2"]