[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100217940":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":40,"locations":45,"responsibleParty":80,"collaborators":83,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":96,"sex":97,"minAge":98,"maxAge":99,"enrollmentInfo":100,"targetDuration":26,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":110,"overallStatus":71,"whyStopped":26,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"University of Houston","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Robot-assisted Rehabilitation","EXPERIMENTAL","Participants will receive Robot-assisted training with the H2 lower limb powered exoskeleton. They will perform walking and other lower limb exercises (as applicable) while wearing the H2 lower limb powered exoskeleton. Training will involve 3 sessions per week for 4 weeks, each lasting about 1.5 hours.",[13],"Behavioral: Robot-assisted training with the H2 lower limb powered exoskeleton",{"label":15,"type":16,"description":17,"interventionNames":18},"Supervised motor practice","ACTIVE_COMPARATOR","Participants in this group will perform walking and other lower limb exercises (as applicable) under the supervision of a research physical therapist. Training will be for 3 sessions per week for 4 weeks, each session lasting about 1.5 hours.",[19],"Behavioral: Supervised motor practice",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Robot-assisted training with the H2 lower limb powered exoskeleton","The H2 is a powered, robotic lower limb exoskeleton with actuated hips, knees and ankles. A custom control algorithm has been implemented in this device, which allows for provision of assistance to lower limb segments during movement, dependent on user needs.",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Supervised motor practice involves lower limb rehabilitation, primarily walking and other applicable lower limb exercises performed by participants under the guidance and supervision of a research physical therapist.",[15],[31,34,37],{"name":32,"affiliation":5,"role":33},"Jose L Contreras-Vidal, PhD","PRINCIPAL_INVESTIGATOR",{"name":35,"affiliation":36,"role":33},"Gerard E Francisco, MD","TIRR Memorial Hermann Hospital",{"name":38,"affiliation":39,"role":33},"Jose L Pons, PhD","Spanish Research Council",[41],{"name":32,"role":42,"phone":43,"phoneExt":26,"email":44},"CONTACT","713-743-4429","jlcontreras-vidal@UH.EDU",[46,70],{"facility":36,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"NOT_YET_RECRUITING","Houston","Texas","77056","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-95.36327,29.76328,{"lat":57,"lon":56},[60,63,67,68],{"name":35,"role":42,"phone":61,"phoneExt":26,"email":62},"713-797-5244","gerard.e.francisco@uth.tmc.edu",{"name":64,"role":42,"phone":65,"phoneExt":26,"email":66},"Shuo-Hsiu Chang, PT, PhD","713-799-7016","Shuo-Hsiu.Chang@uth.tmc.edu",{"name":35,"role":33,"phone":26,"phoneExt":26,"email":26},{"name":64,"role":69,"phone":26,"phoneExt":26,"email":26},"SUB_INVESTIGATOR",{"facility":5,"status":71,"city":48,"state":49,"zip":72,"country":51,"countryCode":52,"cosmosGeoPoint":73,"geoPoint":75,"contacts":76},"RECRUITING","77204",{"type":54,"coordinates":74},[56,57],{"lat":57,"lon":56},[77,79],{"name":32,"role":42,"phone":43,"phoneExt":26,"email":78},"jlcontreras-vidal@uh.edu",{"name":32,"role":33,"phone":26,"phoneExt":26,"email":26},{"type":33,"investigatorFullName":81,"investigatorTitle":82,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Jose L.Contreras-Vidal, Ph.D.","Hugh Roy and Lillie Cranz Cullen University Professor",[84,86],{"name":85,"class":6},"The University of Texas Health Science Center, Houston",{"name":87,"class":6},"TIRR Memorial Hermann","100217940","human-machine-system-for-the-h2-lower-limb-exoskeleton-100217940",false,"NCT02114450","Human-Machine System for the H2 Lower Limb Exoskeleton","Human Machine Interface System With the H2 Lower Limb Exoskeleton for Rehabilitation","H2-NeuroExo","Inclusion Criteria:\n\n* Sub-acute or chronic stroke i.e., interval of at least 3 months or interval of at least 6 months from stroke to time of enrollment, respectively;\n* Cognitive ability to assimilate and participate actively in the treatment protocol (Mini Mental State Examination score \\> 24 points, out of a total 30 indicating normal cognitive ability);\n* Modified Rankin scale scores 2-4 (Mild-Moderate functional disability post-stroke);\n* Modified Ashworth Scale of Spasticity score \\\u003C= 2 (ranges from 0-4 with 4 reflecting maximum spasticity);\n* Have no skin integrity issues;\n* Sufficient passive range of motion at the hip (at least 90 deg flexion, 15-20 deg extension), knee (90 deg flexion, complete extension) and ankle (15 deg dorsiflexion, 15 deg plantarflexion);\n* Have no contraindications to standing or walking; able to stand with assistive device for at least 5 minutes, and able to walk with assistive device for 10 m.\n\nExclusion Criteria:\n\n* Severe cognitive and\u002For visual deficit;\n* Hemineglect (determined based on medical record or initial clinical assessment);\n* Severe sensory deficit;\n* Joint contractures of any extremity that limits normal range of motion during ambulation with assistive devices;\n* Skin lesions that may hinder or prevent the application of exoskeleton;\n* Uncontrolled angina;\n* Severe chronic obstructive pulmonary disease;\n* Other medical contraindications; any medical co-morbidities that would prevent standard rehabilitation.\n\nInclusion criteria for healthy, able-bodied participants:\n\n* Able to understand and sign the consent form\n* Age 18-75 years\n\nExclusion criteria for healthy, able-bodied participants:\n\n\\- History of neurological, neuromuscular or physical disability.",true,"ALL","18 Years","75 Years",{"count":101,"type":102},60,"ESTIMATED","INTERVENTIONAL",[105],"NA","This research study will investigate the use of smart lower limb robotic exoskeleton (developed by the CSIC, Spain) in rehabilitation after stroke. It will compare robotic-assisted rehabilitation with supervised motor practice. Additionally, it will also examine the use of noninvasive scalp electroencephalography (EEG) to learn specific brain wave patterns associated with learning to walk on the powered lower limb exoskeleton. The findings will be used to understand human-robot interaction and to design smart orthotic devices that can be controlled by thought activity and assist those that have lost all or part of their walking abilities.",[108,109],"Stroke","Hemiparesis",[108,111,112,113,114],"Paresis","Gait rehabilitation","Human-Machine Interaction","Wearable Robotic Devices","2024-10-26",{"date":117,"type":118},"2024-10-30","ACTUAL",{"date":120,"type":118},"2015-11-20",{"date":122,"type":102},"2029-12",{"name":5,"class":6},2]