[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100294902":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":24,"locations":28,"responsibleParty":41,"collaborators":45,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":24,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":24,"enrollmentInfo":58,"targetDuration":24,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":24,"overallStatus":48,"whyStopped":24,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"Northeast Center for Rehabilitation and Brain Injury","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Freedom Bed","ACTIVE_COMPARATOR","Bed turns and positions subjects automatically for the healing and prevention of pressure injury",[13],"Device: Freedom Bed",{"label":15,"type":10,"description":16,"interventionNames":17},"Group II Low Air Loss\u002FAlternating Pressure Mattress","Bed provides subjects with alternating pressure with low air loss mattress for the healing and prevention of pressure injury",[18],"Device: Group II Low Air Loss\u002FAlternating Pressure Mattress",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","This is an automatic rotational system in a bed designed to disburse capillary pressure",[9],null,{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"Subjects placed on the Group II Low Air Loss\u002FAlternating Pressure Mattresses will require manual repositioning every 2 hours",[15],[29],{"facility":5,"status":24,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":24},"Lake Katrine","New York","12449","United States","US",{"type":36,"coordinates":37},"Point",[38,39],-73.98819,41.98565,{"lat":39,"lon":38},{"type":42,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Annmarie Belfiglio","Occupational Therapy Coordinator",[46],{"name":47,"class":48},"Probed Medical USA","UNKNOWN","100294902","effectiveness-of-the-freedom-bed-as-compared-to-alternating-pressure-mattress-in-treatment-of-pressure-injuries-in-persons-with-limited-mobility-due-to-traumatic-brain-injury-and-or-spinal-cord-injury-100294902",false,"NCT03118960","Effectiveness of the Freedom Bed as Compared to Alternating Pressure Mattress in Treatment of Pressure Injuries in Persons With Limited Mobility Due to Traumatic Brain Injury and \u002For Spinal Cord Injury","Effectiveness of the Freedom Bed and Alternating Pressure Mattress in Treatment of Pressure Injuries in Persons With Limited Mobility Due to Traumatic Brain Injury and \u002For Spinal Cord Injury","Inclusion Criteria:\n\n* Subjects or their legal representative able to provide written consent for study.\n* subjects must be within the height and weight limits of the beds(height range 4'2\"-6' 6\" , weight range 50-300 lbs.)\n* subjects must have an existing treatable stage 2 or Stage 3 wound.\n\nExclusion Criteria:\n\n* Subjects with unstable spinal fractures.\n* Subjects with significant involuntary spasms.\n* Subjects with severe scoliosis. A user must be able to lie in a partial back lying position.\n* Subjects considered obese.","ALL","14 Years",{"count":59,"type":60},9,"ESTIMATED","INTERVENTIONAL",[63],"NA","This non-randomized clinical study will compare pressure injuries and the change in pressure injuries for subjects who are placed on the Freedom Bed compared to those placed on a standard Group II Low Air Loss\u002FAlternating Pressure Mattress in the Ventilator Unit at Northeast Center for Rehabilitation and Brain Injury. Additionally, the incidence of pneumonia, urinary tract infections, circulatory performance, sleep deprivation and caregiver self-perception on performance will be monitored and documented.",[66],"Pressure Injury","2017-04-13",{"date":69,"type":70},"2017-04-18","ACTUAL",{"date":72,"type":70},"2016-09",{"date":74,"type":60},"2017-11",{"name":5,"class":6},1]