[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07703527":3,"trial-entities:NCT07703527":98,"trial-summary:NCT07703527":102},{"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":18,"study_type":19,"primary_purpose":20,"phases":21,"enrollment_info":23,"interventions":26,"primary_outcomes":32,"secondary_outcomes":59,"sex":60,"minimum_age":61,"maximum_age":62,"healthy_volunteers":63,"eligibility_criteria":64,"std_ages":75,"locations":78,"central_contacts":94,"overall_officials":95,"references":96,"see_also_links":97},"NCT07703527","COPD","Modulating Locomotor-Respiratory Coupling Through Adaptive Exoskeleton Assistance in Patients With COPD","NOT_YET_RECRUITING","2028-09","2026-07","2026-07-14","2026-09","University of Nebraska","OTHER",null,"1\\) Purpose: To improve pulmonary rehabilitation outcomes for individuals with COPD by evaluating the effectiveness of a hip-assisted exoskeleton during a single pulmonary rehabilitation session. 2) Eligibility criteria: Participants must be between 45-75 years old, any gender, but must have a BMI of less than 35 kg\u002Fm\\^2, free from co-morbidities that may affect walking patterns, and must have moderate to severe COPD with no other pulmonary or cardiac issues. (Eligible participants will undergo a screening process which includes 6-minute walking test, medical history exam, and spirometry evaluation.) 3) Intervention and evaluation: The experimental collection will be conducted at the Biomechanics Research Building at the University of Nebraska at Omaha. Participants are required to participate in two sessions on two separate days, both including a 30-minute walking session with one session wearing the hip exoskeleton and the other session without the device.",[17],"COPD (Chronic Obstructive Pulmonary Disease)",[],"INTERVENTIONAL","DEVICE_FEASIBILITY",[22],"NA",{"count":24,"type":25},10,"ESTIMATED",[27],{"type":28,"name":29,"description":30,"armGroupLabels":31},"DEVICE","Hip Exoskeleton-Assisted Walking","The intervention is a wearable hip exoskeleton designed to provide assistive torque during treadmill walking. During the assisted walking condition, participants will wear the exoskeleton secured around the waist and thighs. The device will provide powered assistance to the hip joints during walking to reduce the physical demand of locomotion. Participants will complete a 30-minute treadmill walking session at an individualized workload determined during an initial exercise calibration visit. The effects of hip exoskeleton assistance will be evaluated by comparing physiological, respiratory, biomechanical, and exercise tolerance outcomes with a standard walking condition performed without exoskeleton assistance.",[29],[33,37,40,44,48,52,56],{"measure":34,"description":35,"timeFrame":36},"Respiratory Rate and Timing","Measured continuously in real-time using Respiratory Inductance Plethysmography bands worn around the chest and abdomen.","Continuous assessment during the 30-minute treadmill walking bout within each single-day experimental session.",{"measure":38,"description":39,"timeFrame":36},"Locomotor-Respiratory Coupling (LRC) Ratios","Quantifies the frequency coupling and synchronization between breathing cycles (via RIP bands) and walking cycles (via an SMTEC footswitch system to detect heel strikes).",{"measure":41,"description":42,"timeFrame":43},"Dyspnea (Perceived Breathlessness)","Evaluated at the end of each exercise bout using the Modified Borg Scale, ranging from 0 (no breathlessness) to 10 (maximum breathlessness)","Assessed at the end of each treadmill walking bout during the 30-minute exercise session.",{"measure":45,"description":46,"timeFrame":47},"Dynamic Hyperinflation","Evaluated by monitoring the reduction in Inspiratory Capacity (the maximum volume of air inhaled after a regular, calm exhalation) via baseline and post-exercise spirometry.","Measured via spirometry at baseline (pre-exercise) and immediately following the treadmill walking session.",{"measure":49,"description":50,"timeFrame":51},"Walking Kinematics","Captured at 100 Hz using a 17-camera high-speed digital motion capture system with reflective anatomical markers placed on the lower limbs.","Continuously recorded during the active 30-minute treadmill walking period in each session.",{"measure":53,"description":54,"timeFrame":55},"Total Walking Time","Measured precisely using digital stopwatches to record the exact duration of walking bouts during the 30-minute session.","Recorded as the exact cumulative duration of all active walking bouts during the 30-minute session.",{"measure":57,"description":58,"timeFrame":36},"Metabolic Cost \u002F Metabolic Equivalents of Task (METs)","Determined by measuring net O2 consumption and CO2 production using indirect calorimetry.",[],"ALL","45 Years","75 Years",false,{"inclusion":65,"exclusion":70,"raw_text":74},[66,67,68,69],"COPD Diagnosis \\& Severity: Documented FEV1\u002FFVC ratio of \\\u003C 0.7 and a post-bronchodilator FEV1% predicted between 30% and 80% (classifying as moderate to severe COPD).","Age Requirement: Must be between 45 and 75 years old.","Body Mass Index (BMI): Must have a BMI of less than 35 kg\u002Fm\\^2.","Medical Clearance \\& Screening: Must undergo post-bronchodilator spirometry, successfully pass the screening protocol, and receive formal clearance for participation from a physician.",[71,72,73],"Failing to pass the initial spirometry test.","Not being formally cleared for participation by a physician.","Having a diagnosed pulmonary or cardiac issue that would pose a safety hazard during the laboratory treadmill exercise trials.","Inclusion Criteria:\n\n* COPD Diagnosis \\& Severity: Documented FEV1\u002FFVC ratio of \\\u003C 0.7 and a post-bronchodilator FEV1% predicted between 30% and 80% (classifying as moderate to severe COPD).\n* Age Requirement: Must be between 45 and 75 years old.\n* Body Mass Index (BMI): Must have a BMI of less than 35 kg\u002Fm\\^2.\n* Medical Clearance \\& Screening: Must undergo post-bronchodilator spirometry, successfully pass the screening protocol, and receive formal clearance for participation from a physician.\n\nExclusion Criteria:\n\n* Failing to pass the initial spirometry test.\n* Not being formally cleared for participation by a physician.\n* Having a diagnosed pulmonary or cardiac issue that would pose a safety hazard during the laboratory treadmill exercise trials.",[76,77],"ADULT","OLDER_ADULT",[79],{"facility":80,"city":81,"state":82,"zip":83,"country":84,"contacts":85,"geoPoint":91},"UNO Biomechanics","Omaha","Nebraska","68182","United States",[86],{"name":87,"role":88,"phone":89,"email":90},"Farahnaz Fallahtafti","CONTACT","4025543075","ffallahtafti@unomaha.edu",{"lat":92,"lon":93},41.25626,-95.94043,[],[],[],[],{"nct_id":4,"conditions":99,"biomarkers":101},[100],"Chronic Obstructive Pulmonary Disease",[],{"nct_id":4,"found":103,"summary":104,"prompt_version":114},true,{"design":105,"status":106,"heading":107,"summary":108,"follow_up":109,"word_count":110,"commitments":111,"compensation":112,"drugs_mentioned":113},"This is an interventional study with a planned enrollment of 10 participants. The study will evaluate the Hip Exoskeleton-Assisted Walking intervention.","completed","Hip Exoskeleton Assistance for COPD Walking","This study is looking at how a wearable device called a Hip Exoskeleton can help people with Chronic Obstructive Pulmonary Disease (COPD) during walking. The goal is to see if this device can improve how your breathing and walking work together, and reduce shortness of breath. You might be able to join if you are 45 to 75 years old, have moderate to severe COPD, and a body mass index (BMI) less than 35 kg\u002Fm^2. The study will measure your breathing rate, how your breathing and walking are linked, and your feeling of breathlessness during a 30-minute treadmill walk. We don't know the current recruitment status of this study.","Your respiratory rate, locomotor-respiratory coupling ratios, and dyspnea will be assessed continuously during the 30-minute treadmill walking bout within each single-day experimental session.",109,"You would participate in a single-day experimental session at the University of Nebraska at Omaha. This involves wearing the Hip Exoskeleton and walking on a treadmill for 30 minutes.","Not stated in the trial record.",[],"v2"]