[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565104":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":31,"studyPopulation":31,"armGroups":49,"interventions":65,"overallOfficials":76,"centralContacts":80,"locations":89,"responsibleParty":101,"collaborators":103,"id":107,"slug":31,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":31,"eligibilityCriteria":112,"healthyVolunteers":108,"sex":113,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":31,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":31,"overallStatus":125,"whyStopped":31,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"NYU Langone Health","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":28,"otherOutcomes":31},[9,13,16,19,22,25],{"measure":10,"description":11,"timeFrame":12},"Berg Balance Scale (BBS) Score","The BBS is a 14-item objective assessment that static balance and fall risk in adults. Each item is rated on a scale from 0-4. The total score is the sum of responses and ranges from ranges from 0 to 56, with lower scores indicating a higher risk of falling and lower functional mobility.","Discharge Assessment (Day 13-14)",{"measure":14,"description":15,"timeFrame":12},"Ten Meter Walk Test (10mWT) Time","The 10mWT is an assessment of walking speed in meters per second over a distance of 10 meters.",{"measure":17,"description":18,"timeFrame":12},"Six Minute Walk Test (6MWT) Distance","The 6MWT is a sub-maximal exercise test used to assess walking endurance and aerobic capacity. Participants walk around the perimeter of a set circuit for a total of six minutes. The measure is the total distance covered in six minutes.",{"measure":20,"description":21,"timeFrame":12},"Inpatient Rehabilitation Facility Patient Assessment Instrument (IRF-PAI) - Admission Quality Indicator (QI) Score: Transfers","The IRF-PAI QI score is an ordinal categorical variable measuring how much assistance a patient requires to complete the task (transfer) There are six categories (1-6) ranging from complete dependence of the patient on a helper to independent completion of tasks. A score of 1 is assigned to dependent patients, while a score of 6 represents independent completion of tasks by a patient.",{"measure":23,"description":24,"timeFrame":12},"IRF-PAI - Admission QI Score: Cumulative Ambulation","The IRF-PAI QI score is an ordinal categorical variable measuring how much assistance a patient requires to complete the task (ambulation) There are six categories (1-6) ranging from complete dependence of the patient on a helper to independent completion of tasks. A score of 1 is assigned to dependent patients, while a score of 6 represents independent completion of tasks by a patient.",{"measure":26,"description":27,"timeFrame":12},"IRF-PAI - Admission QI Score: Cumulative Stairs","The IRF-PAI QI score is an ordinal categorical variable measuring how much assistance a patient requires to complete the task (stairs) There are six categories (1-6) ranging from complete dependence of the patient on a helper to independent completion of tasks. A score of 1 is assigned to dependent patients, while a score of 6 represents independent completion of tasks by a patient.",[29,32,34,37,39],{"measure":30,"description":31,"timeFrame":12},"Number of Patients Discharged at Home",null,{"measure":33,"description":31,"timeFrame":12},"Number of Patients Discharged at Subacute Rehabilitation Facility",{"measure":35,"description":36,"timeFrame":12},"Number of Steps of Locomotor Training","Measurement of adherence to protocols.",{"measure":38,"description":36,"timeFrame":12},"Time Spent in Locomotor Training",{"measure":40,"description":36,"timeFrame":12},"Number of Minutes Spent in Target HR Zone",{"allocation":42,"interventionModel":43,"interventionModelDescription":31,"primaryPurpose":44,"observationalModel":31,"timePerspective":31,"maskingInfo":45},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":46,"maskingDescription":31,"whoMasked":47},"SINGLE",[48],"OUTCOMES_ASSESSOR",[50,56,60],{"label":51,"type":52,"description":53,"interventionNames":54},"Moderate-Intensity Locomotor Training Program","EXPERIMENTAL","Treatment will be administered for 10 consecutive 1-hour sessions over a 10-day period. Therapists will deliver the assigned intervention as part of standard care.",[55],"Behavioral: Moderate-Intensity Locomotor Training Program",{"label":57,"type":52,"description":53,"interventionNames":58},"High-Intensity Locomotor Training Program",[59],"Behavioral: High-Intensity Locomotor Training Program",{"label":61,"type":62,"description":53,"interventionNames":63},"High-Step Count Locomotor Training Program","ACTIVE_COMPARATOR",[64],"Behavioral: High-Step Count Locomotor Training Program",[66,70,73],{"type":67,"name":51,"description":68,"armGroupLabels":69,"otherNames":31},"BEHAVIORAL","The moderate-intensity program prescribes participants to exert 50-59% of their heart rate (HR) reserve, or a score of 13-15 on Borg's rating of perceived exertion (RPE) scale.",[51],{"type":67,"name":57,"description":71,"armGroupLabels":72,"otherNames":31},"The high-intensity program prescribes participants to exert at least 60% of their heart rate (HR) reserve, or a score of 16-18 on the RPE scale.",[57],{"type":67,"name":61,"description":74,"armGroupLabels":75,"otherNames":31},"The high step count program prescribes at least 600 steps per session, at less than 50% or HR reserve, or less than 13 RPE.",[61],[77],{"name":78,"affiliation":5,"role":79},"Susan Camillieri","PRINCIPAL_INVESTIGATOR",[81,85],{"name":78,"role":82,"phone":83,"phoneExt":31,"email":84},"CONTACT","212-598-6044","Susan.camillieri@nyulangone.org",{"name":86,"role":82,"phone":87,"phoneExt":31,"email":88},"Melissa Chung","646-654-3519","Melissa.chung@nyulangone.org",[90],{"facility":5,"status":31,"city":91,"state":91,"zip":92,"country":93,"countryCode":94,"cosmosGeoPoint":95,"geoPoint":100,"contacts":31},"New York","10016","United States","US",{"type":96,"coordinates":97},"Point",[98,99],-74.00597,40.71427,{"lat":99,"lon":98},{"type":102,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[104],{"name":105,"class":106},"National Institutes of Health (NIH)","NIH","100565104",false,"NCT06637839","Optimal Dosing of High-Intensity Locomotor Training for Step Attainment and Locomotor Outcomes in Stroke Patients Undergoing Acute Inpatient Rehabilitation","A Randomized, Double-blind Study Comparing the Effects of Three Distinct High Intensity Locomotor Training Protocols on Locomotor Outcomes in Subacute Stroke Patients Undergoing Adult Inpatient Rehabilitation.","Inclusion Criteria:\n\n• Primary diagnosis of stroke\n\nExclusion Criteria:\n\n* Weightbearing restrictions, uncontrolled cardiopulmonary, metabolic, infectious, or psychiatric disorders, which would preclude aerobic locomotor training\n* Estimated length of stay of less than 14 days\n* Non-ambulatory status prior to admission (unable to walk \\>50 meters)\n* Pregnant","ALL","18 Years","95 Years",{"count":117,"type":118},20,"ESTIMATED","INTERVENTIONAL",[121],"NA","The purpose of this study is to elucidate optimal dosing for High Intensity Gait Training (HIGT) to reduce locomotor disability for those undergoing inpatient rehabilitation (IR) in the subacute phase of stroke recovery.\n\nThis is a randomized controlled trial conducted at a single IR facility. Investigators will randomize patients to receive one of two distinct HIGT interventions or a high step count intervention during standard care.",[124],"Stroke","NOT_YET_RECRUITING","2026-06-24",{"date":128,"type":129},"2026-06-26","ACTUAL",{"date":131,"type":118},"2027-01",{"date":133,"type":118},"2027-12",{"name":5,"class":6},1]