[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07494890":3,"trial-entities:NCT07494890":91,"trial-summary:NCT07494890":94},{"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":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":34,"secondary_outcomes":42,"sex":43,"minimum_age":44,"maximum_age":45,"healthy_volunteers":14,"eligibility_criteria":46,"std_ages":65,"locations":68,"central_contacts":84,"overall_officials":86,"references":89,"see_also_links":90},"NCT07494890","2024-0863-03","Measurement Properties of Mechanical Cost of Walking for Individuals With Walking Impairment","RECRUITING","2027-03-01","2026-03","2026-07-06","2026-06-25","University of Cincinnati","OTHER",false,"Walking impairment following neurologic injury can increase the energy cost of walking threefold, acting as a functional barrier to independence. The goal of this cross-sectional study is to determine the measurement properties of a novel biomechanical cost of walking measure in chronic stroke capable of pinpointing the origins of movement inefficiencies. This research aims to:\n\n1. determine the convergent validity of biomechanical cost of walking with functional measures in relation to metabolic cost of walking,\n2. determine the reliability of biomechanical cost of walking in relation to metabolic cost of walking,\n3. determine the responsiveness of biomechanical cost of walking in relation to metabolic cost of walking.\n\nIndividuals with walking impairment from stroke will complete three 5-minute comfortable speed treadmill walking trials. The 3rd walking trial will be against resistance to increase cost of walking. This single session study will compare the metric properties of biomechanical cost of walking in relation to metabolic cost of walking.",null,[18],"Stroke",[],"INTERVENTIONAL","DIAGNOSTIC",[23],"NA",{"count":25,"type":26},18,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"BEHAVIORAL","Resisted walking","Comfortable speed treadmill walking with resisted forward progression.",[33],"Treadmill walking with and without resistance",[35,39],{"measure":36,"description":37,"timeFrame":38},"Constituent Lower Extremity Work","Energy expenditure calculated using biomechanical variables such as force and limb motion","1st minute and 5th minute of resisted walking trial versus non-resisted walking trial.",{"measure":40,"description":41,"timeFrame":38},"Metabolic Cost of Walking","Energy expenditure calculated using oxygen consumption and carbon dioxide production",[],"ALL","30 Years","80 Years",{"inclusion":47,"exclusion":56,"raw_text":64},[48,49,50,51,52,53,54,55],"Age 30-80 years at the time of consent","Hemiparesis from ischemic and\u002For hemorrhagic strokes","Most recent stroke for which participant sought treatment, at least 3 months prior to study consent","Walking speed \\\u003C1.0 m\u002Fs on the 10-meter walk test","Able to walk 10m over ground with assistive devices as needed","Able to walk at least 5 minutes continuously on the treadmill ≥ 0.1 mile per hour","No contraindications to exercise according to ACSM guidelines","Able to communicate with investigators, follow a 2-step command and correctly answer consent comprehension questions",[57,58,59,60,61,62,63],"Hospitalization for cardiac or pulmonary disease within past 3 months","Implanted pacemaker or defibrillator","Severe lower limb hypertonia (Ashworth \\>2)","Foot drop or lower limb joint instability without adequate stabilizing device","Clinically significant neurologic disorder other than stroke","Other significant medical condition likely to jeopardize safety (e.g. joint contracture, gait limited by pain)","Pregnancy","Inclusion Criteria:\n\n* Age 30-80 years at the time of consent\n* Hemiparesis from ischemic and\u002For hemorrhagic strokes\n* Most recent stroke for which participant sought treatment, at least 3 months prior to study consent\n* Walking speed \\\u003C1.0 m\u002Fs on the 10-meter walk test\n* Able to walk 10m over ground with assistive devices as needed\n* Able to walk at least 5 minutes continuously on the treadmill ≥ 0.1 mile per hour\n* No contraindications to exercise according to ACSM guidelines\n* Able to communicate with investigators, follow a 2-step command and correctly answer consent comprehension questions\n\nExclusion Criteria:\n\n* Hospitalization for cardiac or pulmonary disease within past 3 months\n* Implanted pacemaker or defibrillator\n* Severe lower limb hypertonia (Ashworth \\>2)\n* Foot drop or lower limb joint instability without adequate stabilizing device\n* Clinically significant neurologic disorder other than stroke\n* Other significant medical condition likely to jeopardize safety (e.g. joint contracture, gait limited by pain)\n* Pregnancy",[66,67],"ADULT","OLDER_ADULT",[69],{"facility":70,"status":7,"city":71,"state":72,"zip":73,"country":74,"contacts":75,"geoPoint":81},"University of Cincinnati - Digital Futures","Cincinnati","Ohio","45206","United States",[76],{"name":77,"role":78,"phone":79,"email":80},"Christina Garrity, DPT","CONTACT","(513) 558-7499","garritca@mail.uc.edu",{"lat":82,"lon":83},39.12711,-84.51439,[85],{"name":77,"role":78,"phone":79,"email":80},[87],{"name":77,"affiliation":12,"role":88},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":92,"biomarkers":93},[18],[],{"nct_id":4,"found":95,"summary":96,"prompt_version":106},true,{"design":97,"status":98,"heading":99,"summary":100,"follow_up":101,"word_count":102,"commitments":103,"compensation":104,"drugs_mentioned":105},"This is an interventional study, meaning participants will receive a specific intervention (resisted walking). It aims to enroll 18 participants.","completed","Study on Mechanical Cost of Walking for Stroke Survivors","This study is looking at a new way to measure how much effort it takes for people with walking difficulties after a stroke to move. It's called \"Resisted walking\" and involves walking on a treadmill with some resistance. The goal is to understand if this new measurement, called \"biomechanical cost of walking,\" can accurately show how efficient your walking is, similar to how we measure the energy your body uses (metabolic cost of walking). Researchers want to see if this new measure is reliable and can detect changes in walking efficiency. You might be able to join if you are 30-80 years old, had a stroke at least 3 months ago, and have some walking impairment, like walking slower than 1.0 meter per second. The study plans to enroll 18 participants.","Measurements are taken at the 1st and 5th minute of the walking trials. No further follow-up is specified.",131,"Participants will engage in comfortable speed treadmill walking with resisted forward progression. Measurements will be taken at the 1st and 5th minute of these walking trials.","Not stated in the trial record.",[30],"v2"]