[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100408159":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":53,"centralContacts":57,"locations":66,"responsibleParty":83,"collaborators":62,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":62,"eligibilityCriteria":91,"healthyVolunteers":87,"sex":92,"minAge":93,"maxAge":62,"enrollmentInfo":94,"targetDuration":62,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":62,"overallStatus":69,"whyStopped":62,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"NextStep Robotics Inc.","INDUSTRY",[8,14,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"PTR (Physical Therapy while wearing Robot group) (Phase II)","EXPERIMENTAL","Subjects receive 18 one-hour PT training sessions over 9 weeks while wearing the robot initially parameterized to individual deficit severity. Subjects perform over-ground mobility tasks of increasing challenge with robotic assist, as needed. Training is generally divided into 3 phases based on individual ability to address gait deficits, postural transitions, physical demand and environmental terrain.",[13],"Device: PTR Physical Therapy while wearing Robot group (Phase II)",{"label":15,"type":16,"description":17,"interventionNames":18},"PT (Physical Therapy Only) (Phase II)","ACTIVE_COMPARATOR","Subjects receive 18 one-hour PT training sessions over 9 weeks. Subjects perform over-ground mobility tasks of increasing challenge with therapist assist, as needed. Training is generally divided into 3 phases based on individual ability to address gait deficits, postural transitions, physical demand and environmental terrain.",[19],"Other: Physical Therapy Only (Phase II)",{"label":21,"type":10,"description":22,"interventionNames":23},"X-PTR, Cross over group for Physical Therapy n Sub-Acute group.","Participants enrolled in the physical therapy only group will be given the option to re-enroll as a cross over participant to receive 18 one-hour PT training sessions over 9 weeks while wearing the robot initially parameterized to individual deficit severity. Subjects perform over-ground mobility tasks of increasing challenge with robotic assist, as needed. Training is generally divided into 3 phases based on individual ability to address gait deficits, postural transitions, physical demand and environmental terrain.",[24],"Device: Cross over group for Physical Therapy n Sub-Acute group. (Phase II)",{"label":26,"type":10,"description":27,"interventionNames":28},"C-PTR, Chronic Stroke Subjects to receive robotic gait training therapy.","Chronic stroke subjects receive 18 one-hour PT training sessions over 9 weeks while wearing the robot initially parameterized to individual deficit severity. Subjects perform over-ground mobility tasks of increasing challenge with robotic assist, as needed. Training is generally divided into 3 phases based on individual ability to address gait deficits, postural transitions, physical demand and environmental terrain.",[29],"Device: Chronic Stroke Subjects to receive robotic gait training therapy.",[31,37,43,48],{"type":32,"name":33,"description":11,"armGroupLabels":34,"otherNames":35},"DEVICE","PTR Physical Therapy while wearing Robot group (Phase II)",[9],[36],"PTR",{"type":38,"name":39,"description":17,"armGroupLabels":40,"otherNames":41},"OTHER","Physical Therapy Only (Phase II)",[15],[42],"PT",{"type":32,"name":44,"description":22,"armGroupLabels":45,"otherNames":46},"Cross over group for Physical Therapy n Sub-Acute group. (Phase II)",[21],[47],"X-PTR",{"type":32,"name":49,"description":27,"armGroupLabels":50,"otherNames":51},"Chronic Stroke Subjects to receive robotic gait training therapy.",[26],[52],"C-PTR",[54],{"name":55,"affiliation":5,"role":56},"Brad Hennessie, MHA, MBA","STUDY_DIRECTOR",[58,64],{"name":59,"role":60,"phone":61,"phoneExt":62,"email":63},"Josh Rudnicki","CONTACT","443-869-3518",null,"JRudnicki@som.umaryland.edu",{"name":65,"role":60,"phone":62,"phoneExt":62,"email":62},"Richard Macko, MD",[67],{"facility":68,"status":69,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"University of Maryland Rehabilitation & Orthopaedic Institute","RECRUITING","Baltimore","Maryland","21207","United States","US",{"type":76,"coordinates":77},"Point",[78,79],-76.61219,39.29038,{"lat":79,"lon":78},[82],{"name":59,"role":60,"phone":61,"phoneExt":62,"email":63},{"type":84,"investigatorFullName":62,"investigatorTitle":62,"investigatorAffiliation":62,"oldNameTitle":62,"oldOrganization":62},"SPONSOR","100408159","ankle-robotics-after-stroke-100408159",false,"NCT04594837","Ankle Robotics After Stroke","Portable Ankle Robotics to Reverse Foot Drop After Stroke","Inclusion Criteria:\n\n* Ages 18 and older\n* In the subacute phase of stroke recovery (\\>6 weeks to \\\u003C6 months post-stroke) with residual hemiparesis of the lower extremity that includes symptoms of foot-drop. - or - In the chronic phase of stroke recovery (\\>6 months post-stroke) with residual hemiparesis of the lower extremity that includes symptoms of foot-drop.\n* Clear indications of hemiparetic gait by clinical observation\n\nExclusion Criteria:\n\n* Cardiac history of (a) unstable angina, (b) recent (less than 3 months) myocardial infarction, congestive heart failure (NYHA category II); (c) hemodynamically significant valvular dysfunction\n* Hypertension that is a contraindication for routine physical therapy (greater than 160\u002F100 on two assessments).\n* Medical History: (a) recent hospitalization (less than 3 months) for severe medical disease, (b) symptomatic peripheral arterial occlusive disease, (c) orthopedic or chronic pain conditions that significantly alter gait function, (d) pulmonary or renal failure (e) active cancer\n* History of non-stroke neuromuscular disorder restricting gait.\n* Aphasia or cognitive functioning that confounds participation, defined as unable to follow 2 step commands or judgment of the medical officer or therapist.","ALL","18 Years",{"count":95,"type":96},140,"ESTIMATED","INTERVENTIONAL",[99],"NA","The randomized study (in Phase II of the U44) compares the efficacy and durability of 9 weeks (18 sessions) of robot-assisted physical therapy (PTR) versus physical therapy (PT) alone on foot drop as assessed by gait biomechanics (ankle angle at initial contact, peak swing ankle angle, number of heel-first strikes - % total steps, gait velocity) and blinded clinician assessment (dorsiflexion active range of motion, ankle muscle strength, assistive device needs).",[102,103,104],"Foot Drop","Stroke","Hemiparesis","2023-01-24",{"date":107,"type":108},"2023-01-26","ACTUAL",{"date":110,"type":108},"2020-08-20",{"date":112,"type":96},"2025-02-28",{"name":5,"class":6},1]