[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595933":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":39,"locations":47,"responsibleParty":70,"collaborators":73,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":26,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":26,"enrollmentInfo":85,"targetDuration":26,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":97,"whyStopped":26,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Indiana University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"VR-Assisted Overground Gait Therapy","EXPERIMENTAL","Participants in the treatment group (VG-AOGT) will engage in gait training within a newly developed immersive virtual reality (VR) environment. This setup features self-propelled overground walking influenced by three different virtual environments designed to mimic real-world conditions. The immersive technology used is HTC VIVE Focus Vision, enabling participants to practice walking in real-world environments and gait tasks.",[13],"Device: Walk-over-Ground",{"label":15,"type":16,"description":17,"interventionNames":18},"Conventional Treadmill-Based VR Gait Therapy","ACTIVE_COMPARATOR","Participants in the control group (VR-CTGT) will engage in gait training using C-Mill VR+ technology, which involves treadmill-assisted walking on a treadmill while interacting with less immersive virtual scenarios presented on screens.",[19],"Device: C-Mill VR+ by Motek",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","C-Mill VR+ by Motek","Participants perform treadmill-assisted walking while interacting with non-immersive, game-like environments displayed on screens attached to the treadmill.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Walk-over-Ground","This intervention utilizes the HTC VIVE Focus Vision system for a realistic, fully immersive VR-assisted overground gait therapy. The immersive VR environment is designed to mimic real-world scenarios and challenges, enhancing the rehabilitation process by engaging patients in naturalistic gait activities.",[9],[32,36],{"name":33,"affiliation":34,"role":35},"Hee-Tae Jung, Ph.D.","Indiana University, Luddy School of Informatics, Computing, and Engineering","PRINCIPAL_INVESTIGATOR",{"name":37,"affiliation":38,"role":35},"Peter Altenburger, Ph.D., PT","Indiana University, School of Health & Human Sciences; Indiana University Health, Center for Advanced Neurorehabilitation",[40,44],{"name":37,"role":41,"phone":42,"phoneExt":26,"email":43},"CONTACT","317-278-0703","paltenbu@iu.edu",{"name":33,"role":41,"phone":45,"phoneExt":26,"email":46},"317-278-1285","heetjung@iu.edu",[48],{"facility":49,"status":26,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Indiana University Health, Neurorehabilitation & Robotics","Indianapolis","Indiana","46202","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-86.15804,39.76838,{"lat":59,"lon":58},[62,63,67,68],{"name":37,"role":41,"phone":42,"phoneExt":26,"email":43},{"name":64,"role":41,"phone":65,"phoneExt":26,"email":66},"Kathryn Gyves, PT, DPT, NCS, CSRS, AVPT, CBIS","317-963-7050","kgyves@iuhealth.org",{"name":37,"role":35,"phone":26,"phoneExt":26,"email":26},{"name":33,"role":69,"phone":26,"phoneExt":26,"email":26},"SUB_INVESTIGATOR",{"type":35,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Hee-Tae Jung","Assistant Professor, Health Informatics",[74],{"name":75,"class":6},"Indiana University Health","100595933","overground-virtual-reality-vr-gait-rehabilitation-for-traumatic-brain-injury-tbi-100595933",false,"NCT07038889","Overground Virtual Reality (VR) Gait Rehabilitation for Traumatic Brain Injury (TBI)","Investigating the Feasibility and Translational Therapeutic Benefits of Overground, Fully Immersive Virtual Reality (VR) Gait Rehabilitation Therapies for Individuals With Traumatic Brain Injury (TBI)","Inclusion Criteria:\n\n* Diagnosis: A confirmed diagnosis of traumatic brain injury (TBI), confirmed by the referring physician.\n* Cognitive Function: Mini-Mental State Examination (MMSE) score ≥ 24 or Montreal Cognitive Assessment (MoCA) score ≥ 20, indicating sufficient cognitive function to participate in the study.\n* Exercise Clearance: Approval from a physician for participation in exercise-based interventions.\n* Rehabilitation Need: Demonstrates a need for functional rehabilitation.\n* Recent Therapy: Participants should not have received physical therapy (PT) within the last month.\n* Consent: Must be able to provide informed consent for themselves.\n\nExclusion Criteria:\n\n* Participants with unstable medication regimens that could interfere with their participation in the study.\n* Any comorbidity that could interfere with walking or gait training.\n* Participation in VR-assisted gait training within the last 6 months.\n* Intolerance to virtual reality environments or motion simulation.\n* Severe cognitive, visual, or hearing impairments where the participant cannot follow the therapist's instructions.\n* More than 135 kg total body weight.\n* More than 2.00 meters in body height.\n* Presence of open skin lesions or bandages in areas that would come into contact with the harness.\n* Functional Ambulation Category (FAC): Participants with an FAC score of less than 2 indicate they require physical support from more than one person to walk.\n\nClarification:\n\n\\- The diagnosis of TBI can be confirmed by their physician or a physical therapist referring to the patient. If a physical therapist makes the referral, the diagnosis must still be officially confirmed by a physician to ensure it meets the study's medical criteria.","ALL","18 Years",{"count":86,"type":87},30,"ESTIMATED","INTERVENTIONAL",[90],"NA","The purpose of this study is to evaluate a new virtual reality (VR)-based rehabilitation program designed to help individuals with traumatic brain injury (TBI) improve their walking abilities in real-world settings. By comparing immersive VR-assisted overground gait therapy to contemporary non-immersive, treadmill-based VR therapy (i.e., C-Mill), the investigators aim to determine its effectiveness in enhancing mobility and quality of life for TBI patients.",[93],"Traumatic Brain Injury",[95,96,93],"Gait Training","Virtual Reality","NOT_YET_RECRUITING","2026-06-24",{"date":100,"type":101},"2026-06-26","ACTUAL",{"date":103,"type":87},"2026-07",{"date":105,"type":87},"2027-06",{"name":5,"class":6},1]