[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05729061":3,"trial-entities:NCT05729061":120,"trial-summary:NCT05729061":126},{"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":14,"conditions":16,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":52,"secondary_outcomes":61,"sex":73,"minimum_age":74,"maximum_age":75,"healthy_volunteers":76,"eligibility_criteria":77,"std_ages":95,"locations":98,"central_contacts":113,"overall_officials":115,"references":118,"see_also_links":119},"NCT05729061","AD-001","Analysis of Human Movement With Assistive Devices","RECRUITING","2024-11-28","2023-10","2023-10-10","2022-11-28","Orthocare Innovations, LLC","INDUSTRY",null,"The purpose of this research is to evaluate how people move about in different settings with different assistive devices or components, and to understand how people interact with different assistive technologies. Individuals that have limb weakness, limb paralysis, limb loss, and movement disorders are often provided assistive devices such as prostheses and orthoses to assist with mobility or use assistive technologies for purposes such as to regain muscle strength or retrain movements. It is important to understand the impact of these different assistive technologies on human movement for technology improvement and in preparation for commercialization.\n\nBecause this research focuses on evaluating how different people move about in different settings with different assistive devices\u002Fcomponents, there are different activities that may take place. These activities have been classified as (1) Movement Analysis in the Laboratory, (2) Movement Analysis Outside the Laboratory, (3) Usability Testing, and (4) Focus Groups. Each participant may or may not complete the same activities as the other participants. Each participant may or may not complete all of the activities. Participants may complete the activities more than once.",[17,18,19,20],"Limb Loss","Limb Weakness","Limb Paralysis","Movement Disorders",[],"INTERVENTIONAL","OTHER",[25],"NA",{"count":27,"type":28},100,"ESTIMATED",[30,36,40,44,48],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DEVICE","Assist-Knee","Investigational prosthetic knee-ankle device",[35],"Participant with intervention",{"type":31,"name":37,"description":38,"armGroupLabels":39},"Prosthetic Knee","Commercially available prosthetic knee devices",[35],{"type":31,"name":41,"description":42,"armGroupLabels":43},"Prosthetic Ankle","Commercially available prosthetic ankle devices",[35],{"type":31,"name":45,"description":46,"armGroupLabels":47},"Prosthetic Foot","Commercially available prosthetic foot devices",[35],{"type":31,"name":49,"description":50,"armGroupLabels":51},"Ankle-Foot Orthosis","Commercially available ankle-foot orthosis devices",[35],[53,57],{"measure":54,"description":55,"timeFrame":56},"Walking Speed with no intervention","Walking speed determined over 8 meters of walking","Collection at baseline",{"measure":58,"description":59,"timeFrame":60},"Walking Speed with intervention","Walking speed calculated over 8 meters of walking","Collection immediately after acclimation with intervention",[62,65,67,70],{"measure":63,"description":64,"timeFrame":56},"Time to Complete Sit-to-Stand with no intervention","The amount of time, measured in seconds, needed by the subject to complete the sit-to-stand transition. At least three trials of the sit-to-stand maneuver are collected for each participant using a motion analysis system. Average and standard deviation of the time to complete the sit-to-stand transition are calculated for each participant. The start of the transition will be determined by participant initiation; the end of the transition will be determined by the participant reaching full knee extension.",{"measure":66,"description":64,"timeFrame":60},"Time to Complete Sit-to-Stand with intervention",{"measure":68,"description":69,"timeFrame":56},"Timed Up and Go (TUG) Test","The Timed Up and Go (TUG) test is a validated timed functional test that involves standing up from a chair, walking forward for 3 meters, turning around, walking back to the chair for 3 meter, and sitting down. Each participant will complete the TUG test for three trials. Time is measured using a stopwatch. Average and standard deviation of the time to complete the TUG test are calculated for each participant.",{"measure":71,"description":69,"timeFrame":72},"Timed Up and Go (TUG) Test with intervention","Collected immediately after acclimation with intervention","ALL","18 Years","90 Years",true,{"inclusion":78,"exclusion":89,"raw_text":94},[79,80,81,82,83,84,79,85,86,87,81,82,83,84,88],"Age 18 - 90 years","Has bilateral normal range of motion","Able to perform a variety of movement activities","Able to communicate and write individual perceptions in English","Able to provide written informed consent","Participants that will use a treadmill during data collection must also be able to walk independently and safely on a treadmill","Has a condition or diagnosis that results in limb weakness, limb paralysis, limb loss, or movement disorders","Medically stable","Has stable balance","Able to safely complete the movements being tested and\u002For safely use the assistive devices being tested",[90,91,92,93,91,92],"Health issues (e.g., confounding injury, musculoskeletal, or cognitive) or other issues (e.g., transportation or schedule issues) that limit effective participation and\u002For may not represent a nondisabled condition","Pregnancy","Not able to read and understand English","Health issues (e.g., confounding injury, musculoskeletal, or cognitive) or other issues (e.g., transportation or schedule issues) that limit effective participation and\u002For may result in mixed effects of multiple sources of disability","Inclusion Criteria for Nondisabled Participants:\n\n* Age 18 - 90 years\n* Has bilateral normal range of motion\n* Able to perform a variety of movement activities\n* Able to communicate and write individual perceptions in English\n* Able to provide written informed consent\n* Participants that will use a treadmill during data collection must also be able to walk independently and safely on a treadmill\n\nExclusion Criteria for Nondisabled Participants:\n\n* Health issues (e.g., confounding injury, musculoskeletal, or cognitive) or other issues (e.g., transportation or schedule issues) that limit effective participation and\u002For may not represent a nondisabled condition\n* Pregnancy\n* Not able to read and understand English\n\nInclusion Criteria for Participants with a Disability:\n\n* Age 18 - 90 years\n* Has a condition or diagnosis that results in limb weakness, limb paralysis, limb loss, or movement disorders\n* Medically stable\n* Has stable balance\n* Able to perform a variety of movement activities\n* Able to communicate and write individual perceptions in English\n* Able to provide written informed consent\n* Participants that will use a treadmill during data collection must also be able to walk independently and safely on a treadmill\n* Able to safely complete the movements being tested and\u002For safely use the assistive devices being tested\n\nExclusion Criteria for Participants with a Disability:\n\n* Health issues (e.g., confounding injury, musculoskeletal, or cognitive) or other issues (e.g., transportation or schedule issues) that limit effective participation and\u002For may result in mixed effects of multiple sources of disability\n* Pregnancy\n* Not able to read and understand English",[96,97],"ADULT","OLDER_ADULT",[99],{"facility":12,"status":7,"city":100,"state":101,"zip":102,"country":103,"contacts":104,"geoPoint":110},"Edmonds","Washington","98020","United States",[105],{"name":106,"role":107,"phone":108,"email":109},"Adam Arabian, PhD","CONTACT","425-771-0797","arabian@orthocareinnovations.com",{"lat":111,"lon":112},47.81065,-122.37736,[114],{"name":106,"role":107,"phone":108,"email":109},[116],{"name":106,"affiliation":12,"role":117},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":121,"biomarkers":125},[17,122,123,124],"Limb paralysis","Movement Disorder","Muscle weakness of limb",[],{"nct_id":4,"found":76,"summary":127,"prompt_version":137},{"design":128,"status":129,"heading":130,"summary":131,"follow_up":132,"word_count":133,"commitments":134,"compensation":135,"drugs_mentioned":136},"This is an interventional study planning to enroll 100 participants. The study will compare walking speed with and without different assistive devices.","completed","Understanding Movement with Assistive Devices","This study aims to understand how people move using different assistive devices, like prosthetics (artificial limbs) and orthotics (braces), and how they interact with these technologies. Researchers will look at how people with limb weakness, limb paralysis, limb loss, or movement disorders use devices such as the investigational Assist-Knee, or commercially available prosthetic knees, ankles, feet, and ankle-foot orthoses. The main goal is to measure walking speed both without an intervention and immediately after using an intervention. This research will help improve assistive technologies. You may be able to join if you are between 18 and 90 years old and can perform various movement activities.","Walking speed will be measured at the start of the study and immediately after using an intervention.",105,"Not specified in the trial record.","Not stated in the trial record.",[32,37],"v2"]