[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610624":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":11,"studyPopulation":11,"armGroups":42,"interventions":49,"overallOfficials":11,"centralContacts":54,"locations":60,"responsibleParty":77,"collaborators":11,"id":79,"slug":11,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":85,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":11,"studyType":92,"phases":93,"briefSummary":94,"conditions":95,"keywords":11,"overallStatus":63,"whyStopped":11,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Pôle Saint Hélier","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":23,"otherOutcomes":11},[9,13,15,17,19,21],{"measure":10,"description":11,"timeFrame":12},"Perceptive dimension : Elements of the environment viewed : Distribution (in %)",null,"From enrollment to the end of the participation at maximum 30 days",{"measure":14,"description":11,"timeFrame":12},"Perceptive dimension : Elements of the environment viewed : Distance (in meters)",{"measure":16,"description":11,"timeFrame":12},"Perceptive dimension : Elements of the environment viewed : duration of fixations (in milliseconds)",{"measure":18,"description":11,"timeFrame":12},"Cognitive dimension : characteristics of the path taken : length of the path taken (in meters)",{"measure":20,"description":11,"timeFrame":12},"Cognitive dimension : characteristics of the path taken : interpersonal distances with virtual humans (in m)",{"measure":22,"description":11,"timeFrame":12},"Action-related dimension : walking speed (measured in m\u002Fs)",[24,27,30,32,34],{"measure":25,"description":11,"timeFrame":26},"\" Montréal Cognitive Assesment \" (MoCA)","On day 1",{"measure":28,"description":11,"timeFrame":29},"\" 10-Meter Walking Test \" (10MWT)","At day 1",{"measure":31,"description":11,"timeFrame":29},"Balance test : ABC-scale",{"measure":33,"description":11,"timeFrame":29},"Balance test : \"Berg Balance Scale\" (BBS)",{"measure":35,"description":11,"timeFrame":29},"Balance test : \"Time Up and Go\" (TUG)",{"allocation":37,"interventionModel":38,"interventionModelDescription":11,"primaryPurpose":39,"observationalModel":11,"timePerspective":11,"maskingInfo":40},"NA","SINGLE_GROUP","BASIC_SCIENCE",{"masking":41,"maskingDescription":11,"whoMasked":11},"NONE",[43],{"label":44,"type":45,"description":46,"interventionNames":47},"Single group","EXPERIMENTAL","Patients as well as healthy participants will be asked to perform several exercises under virtual reality conditions. Questionnaires and scales will also be completed by the participants.",[48],"Other: Locomotion in a virtual reality setting",[50],{"type":6,"name":51,"description":52,"armGroupLabels":53,"otherNames":11},"Locomotion in a virtual reality setting","Patients and participants will be asked to perform several walking\u002Flocomotion tasks in a virtual evironment setting. The setting in question is a concert in a parc. The participants will have to walk towards the stage whilst avoiding bumping into \"virtual people\". A total of 5 different tasks (walking in a straight line, walking between people etc) will be completed for each participant. Different variables will then be recorded and extracted such as walking speed, interpersonnal distances, eye fixation times.",[44],[55],{"name":56,"role":57,"phone":58,"phoneExt":11,"email":59},"Emilie Leblong, MD","CONTACT","+33299295043","emilie.leblong@fondationsainthelier.com",[61],{"facility":62,"status":63,"city":64,"state":11,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Fondation Saint Helier","RECRUITING","Rennes","35043","France","FR",{"type":69,"coordinates":70},"Point",[71,72],-1.67431,48.11109,{"lat":72,"lon":71},[75],{"name":76,"role":57,"phone":58,"phoneExt":11,"email":59},"Emilie Leblong",{"type":78,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100610624",false,"NCT07230002","Effects of Moderate\u002FSevere Traumatic Brain Injury in the Subacute or Chronic Phase on Locomotor Strategies Involved in Navigation in Complex Virtual Environments","NAVIGO","Inclusion Criteria for Traumatic Brain Injury group :\n\n* 18 ≤ Age ≤ 55 years old\n* Male\u002Ffemale\n* Having suffered a first non-penetrating head injury\n* Moderate to severe severity with initial Glasgow Coma Scale score 5\\\u003CGCS\\\u003C13\n* In the subacute or chronic phase (≥ 3 months at the date of the experiment, relative to the date of the injury)\n* Able to walk (10WMT speed ≥ 0.8 m\u002Fs, able to walk at least 20 m without technical or human assistance, PM ≥ 300 m)\n* Able to maintain dynamic balance while standing (TUG\\\u003C16s)\n* Able to answer simple questionnaires, according to the investigator's judgment\n* Having given their free, informed, expressed (written) consent\n* Registered with a social security system\n* Individuals under legal protection measures such as guardianship may be eligible\n\nInclusion Criteria for healthy control group :\n\n* 18 ≤ Age ≤ 55 years old\n* Male\u002Ffemale\n* Able to walk (≥ 0.8 m\u002Fs, able to walk at least 20 m without technical or human assistance, PM ≥ 300 m)\n* Able to answer simple questionnaires, according to the investigator's judgment\n* Having given free, informed, expressed (written) consent\n* Registered with a social security system\n\nExclusion Criteria specific to patients in the traumatic brain injury group :\n\n\\- Person under legal protection (excluding guardianship) or unable to express consent\n\nExclusion Criteria for both groups :\n\n* Severe patho-psychiatric care underway, which may impact the conduct of the protocol, at the investigator's discretion\n* Presence of neurological signs suggestive of a neurodegenerative disease responsible for gait disturbance (Parkinson's syndrome, Alzheimer's disease, etc.)\n* Individuals with musculoskeletal disorders that impact their locomotor abilities\n* Presence of uncontrolled epilepsy at the time of inclusion\n* Presence of visual impairments that make experimentation impossible, at the discretion of the investigator\n* Pregnant, parturient, or breastfeeding women\n* Participants in another ongoing research protocol involving human subjects\n\nExclusion Criteria for healthy control group :\n\n* Presence of fatigue, trauma, or a condition affecting mobility, posture, balance, or walking\n* Persons deprived of their liberty by a judicial or administrative decision\n* Persons deprived of their liberty by judicial or administrative decision\n* Persons under legal protection (guardianship, curatorship, judicial protection) or unable to express their consent\n* Persons undergoing severe psychiatric treatment or admitted to a health or social care facility for purposes other than research.",true,"ALL","18 Years","55 Years",{"count":90,"type":91},40,"ESTIMATED","INTERVENTIONAL",[37],"While clinical assessment of locomotor function in this population is carried out using tasks involving walking in a straight line without any obstacles, it does not take into account ecological situations (i.e., situations comparable to real-life situations) in which the person interacts with their environment, such as walking down a street with other pedestrians, which is fundamental to everyday life. This research therefore aims to study the social navigation skills during locomotion of people who have suffered a moderate or severe head injury in the chronic phase in more ecological tasks. This will provide a better understanding of the difficulties encountered by these patients during locomotor interactions in everyday life.",[96],"Traumatic Brain Injury","2025-11-14",{"date":99,"type":100},"2025-11-17","ACTUAL",{"date":102,"type":91},"2025-11-30",{"date":104,"type":91},"2026-10-30",{"name":5,"class":6},1]