[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07158580":3,"trial-entities:NCT07158580":89,"trial-summary:NCT07158580":93},{"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":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":36,"secondary_outcomes":47,"sex":48,"minimum_age":49,"maximum_age":22,"healthy_volunteers":50,"eligibility_criteria":51,"std_ages":61,"locations":63,"central_contacts":79,"overall_officials":84,"references":87,"see_also_links":88},"NCT07158580","2025-1220","Opti Gait Wearable Gait Tracker","Opti Gait Wearable Gait Tracker: Pilot Trial l With Healthy Older Adults","NOT_YET_RECRUITING","2027-09","2026-08","2026-08-18","2026-09","University of Wisconsin, Madison","OTHER",false,"The purpose of this observational study is to test a shoe mounted gait monitoring device that was refined with the input of older adults and assess the efficacy of the refinements through a series of tests that involve walking with and without the device.","In this testing, researchers seek to validate the precision, accuracy and robustness of the community-corefined device with healthy older adults, aged 65 years and above, by conducting walking tests on a state of the art GaitRite gaitmat to assess various gait metrics and on a flight of stairs to assess gait height. Following this, researchers will conduct a semi structured interview that will comprise a series of yes\u002Fno questions and open ended questions to understand the efficacy of the refinements and further refinement directions.",[19],"Seniors",[],"OBSERVATIONAL",null,[],{"count":25,"type":26},20,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":34},"DEVICE","Gait Tracker","Opti Gait is a wearable gait tracker",[33],"No gait or mobility issues",[35],"OptiGait Wearable Gait Tracker",[37,41,44],{"measure":38,"description":39,"timeFrame":40},"Change in walking speed","Participants will walk 4 meters with and without the shoe mounted device to assess the change in walking speed","3 hours",{"measure":42,"description":43,"timeFrame":40},"Change in natural gait","Participants will walk on a gait mat to assess natural gait, and then will walk on the gait mat wearing the device to assess the change in natural gait. Gait metrics captured by OptiGait will be compared with those captured by GaitRite to understand accuracy and precision.",{"measure":45,"description":46,"timeFrame":40},"Gait height","Participants will climb a flight of five stairs, wearing the device, to measure gait height.",[],"ALL","65 Years",true,{"inclusion":52,"exclusion":56,"raw_text":60},[53,54,55],"Aged 65 years and older","Able to speak and understand English,","Able to provide consent",[57,58,59],"Current or recent (\\\u003C 1 year) major psychiatric condition","Significant medical condition such that usability evaluation could pose substantial health or safety risk","Individuals with an activated power of attorney will be excluded from the study","Inclusion Criteria:\n\n* Aged 65 years and older\n* Able to speak and understand English,\n* Able to provide consent\n\nExclusion Criteria:\n\n* Current or recent (\\\u003C 1 year) major psychiatric condition\n* Significant medical condition such that usability evaluation could pose substantial health or safety risk\n* Individuals with an activated power of attorney will be excluded from the study",[62],"OLDER_ADULT",[64],{"facility":65,"city":66,"state":67,"zip":68,"country":69,"contacts":70,"geoPoint":76},"University of Wisconsin - Madison","Madison","Wisconsin","53705","United States",[71],{"name":72,"role":73,"phone":74,"email":75},"Jayer Fernandes, PhD","CONTACT","608-358-3799","jfernandes@wisc.edu",{"lat":77,"lon":78},43.07305,-89.40123,[80,81],{"name":72,"role":73,"phone":74,"email":75},{"name":82,"role":73,"email":83},"Kristen Pickett, PhD","kristen.pickett@wisc.edu",[85],{"name":72,"affiliation":13,"role":86},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":90,"biomarkers":92},[91],"Healthy Volunteers",[],{"nct_id":4,"found":50,"summary":94,"prompt_version":104},{"design":95,"status":96,"heading":97,"summary":98,"follow_up":99,"word_count":100,"commitments":101,"compensation":102,"drugs_mentioned":103},"This is an observational study involving 20 seniors. It is designed to test a device without comparing it to another treatment.","completed","Opti Gait Wearable Gait Tracker for Seniors","This study is looking at a wearable device called Opti Gait, which tracks how people walk. Researchers want to see if changes made to the device, based on feedback from older adults, have improved it. You might be able to join if you are 65 or older, can speak and understand English, and can give your consent. You cannot join if you have a recent major mental health condition, a significant medical condition that would make testing risky, or if someone else has power of attorney for you. The study will measure changes in your walking speed, natural walking pattern, and how high you lift your feet when walking, all within 3 hours. The current recruitment status is unclear.","Your walking will be measured at 3 hours, and then you will have an interview. No further follow-up is specified.",119,"You will participate in walking tests on a special mat and stairs, and then answer questions in an interview. This will take about 3 hours.","Not stated in the trial record.",[],"v2"]