[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07638462":3,"trial-entities:NCT07638462":95,"trial-summary:NCT07638462":99},{"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":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":38,"secondary_outcomes":43,"sex":47,"minimum_age":48,"maximum_age":49,"healthy_volunteers":15,"eligibility_criteria":50,"std_ages":67,"locations":70,"central_contacts":79,"overall_officials":89,"references":93,"see_also_links":94},"NCT07638462","IRB00148157","RIsE Stroke Mobility Study","RIsEStroke (Recovery Insights Into Early Mobility Post Stroke)","RECRUITING","2027-04","2026-05","2026-07-10","2026-07-08","Wake Forest University Health Sciences","OTHER",false,"This study is designed to better understand how patients with severe stroke move during their hospital stay. It will track their activity using a small wearable device (activPAL) along with standard mobility information already collected in clinical care. The goal is to learn what typical movement patterns look like early after a stroke and how well patients meet mobility goals while in the hospital. What is learned from this study may allow determination of how treatment for stroke patients may be improved to improve patient long-term mobility.","Acute Ischemic Stroke (AIS) is a leading cause of disability and death in the United States. However rehabilitation after stroke has shown to reduce the risk of medical and neurological complications and improved brain recovery. There has been extensive research on early mobilization and advanced therapy after AIS in low to moderate stroke severity patients. There has been little research in the mobility of severe AIS patients.\n\nResearch studies have utilized several different devices to track movement of subjects. The activPAL device has been used extensively in research studies in a variety of diseases and age groups. The activPAL4pro provides data on posture, limb movement, sleep, sitting and ambulatory movement. For this reason, the activPAL4pro device will be utilized to provide extensive data on our AIS patients.",[19],"Acute Ischemic Stroke",[21,22,23],"stroke","mobility","advanced therapy","INTERVENTIONAL","SUPPORTIVE_CARE",[27],"NA",{"count":29,"type":30},50,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DEVICE","activPAL device","The activPAL measures physical activities. When a Participant moves, it moves generating totals for the time spent lying, sitting, standing and stepping, every second of the day.",[37],"Severe Acute Ischemic Stroke Patients",[39],{"measure":40,"description":41,"timeFrame":42},"Achievement of the Johns Hopkins Highest Level of Mobility (JH-HLM) goal based on the Activity Measure for Post-Acute Care (AM-PAC) score","Proportion of participants who achieve the daily JH-HLM mobility goal derived from the AM-PAC \"6-Clicks\" score during hospitalization.","Daily through Day 14",[44],{"measure":45,"description":46,"timeFrame":42},"Frequency of daily achievement of the JH-HLM goal","Number of times per day the participant achieves the JH-HLM mobility goal during hospitalization.","ALL","18 Years",null,{"inclusion":51,"exclusion":57,"raw_text":66},[52,53,54,55,56],"Adults aged 18 years and older","Hospitalized patients with acute ischemic stroke","Initial National Institutes of Health Stroke Scale (NIHSS) score of 10 or greater","Baseline modified Rankin Scale (mRS) score of 0-2","Current modified Rankin Scale (mRS) score of 3-5",[58,59,60,61,62,63,64,65],"Current or expected End-of-life discussions","Current plans for surgical intervention","Patients with pre-mRS of 3-5","Patients with orthopedic, musculoskeletal, integumentary injury that would prevent safe weight bearing, mobility or equipment use","Uncontrolled cardiorespiratory dysfunction or disease","Active\u002Funcontrolled seizures","Isolation status that would prevent mobility outside of the room","Weight that exceeds the safe limits of mobility equipment","Inclusion Criteria:\n\n* Adults aged 18 years and older\n* Hospitalized patients with acute ischemic stroke\n* Initial National Institutes of Health Stroke Scale (NIHSS) score of 10 or greater\n* Baseline modified Rankin Scale (mRS) score of 0-2\n* Current modified Rankin Scale (mRS) score of 3-5\n\nExclusion Criteria:\n\n* Current or expected End-of-life discussions\n* Current plans for surgical intervention\n* Patients with pre-mRS of 3-5\n* Patients with orthopedic, musculoskeletal, integumentary injury that would prevent safe weight bearing, mobility or equipment use\n* Uncontrolled cardiorespiratory dysfunction or disease\n* Active\u002Funcontrolled seizures\n* Isolation status that would prevent mobility outside of the room\n* Weight that exceeds the safe limits of mobility equipment",[68,69],"ADULT","OLDER_ADULT",[71],{"facility":13,"status":8,"city":72,"state":73,"zip":74,"country":75,"geoPoint":76},"Winston-Salem","North Carolina","27157","United States",{"lat":77,"lon":78},36.09986,-80.24422,[80,85],{"name":81,"role":82,"phone":83,"email":84},"Jeremy Rhoten, MHA, RN","CONTACT","704-355-7403","Jeremy.Rhoten@advocatehealth.org",{"name":86,"role":82,"phone":87,"email":88},"Sahra Khan, BS","704-355-9434","Sahra.Khan@Advocatehealth.org",[90],{"name":91,"affiliation":13,"role":92},"Rahul Karamchandani, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":96,"biomarkers":98},[97],"Ischemic Stroke",[],{"nct_id":4,"found":15,"summary":49,"prompt_version":49}]