Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-26 @ 2:49 AM
Study NCT ID:
NCT07230002
Status:
RECRUITING
Last Update Posted:
2025-11-17
First Post:
2025-09-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Moderate/Severe Traumatic Brain Injury in the Subacute or Chronic Phase on Locomotor Strategies Involved in Navigation in Complex Virtual Environments
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008124', 'term': 'Locomotion'}], 'ancestors': [{'id': 'D009068', 'term': 'Movement'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2025-09-25', 'studyFirstSubmitQcDate': '2025-11-14', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perceptive dimension : Elements of the environment viewed : Distribution (in %)', 'timeFrame': 'From enrollment to the end of the participation at maximum 30 days'}, {'measure': 'Perceptive dimension : Elements of the environment viewed : Distance (in meters)', 'timeFrame': 'From enrollment to the end of the participation at maximum 30 days'}, {'measure': 'Perceptive dimension : Elements of the environment viewed : duration of fixations (in milliseconds)', 'timeFrame': 'From enrollment to the end of the participation at maximum 30 days'}, {'measure': 'Cognitive dimension : characteristics of the path taken : length of the path taken (in meters)', 'timeFrame': 'From enrollment to the end of the participation at maximum 30 days'}, {'measure': 'Cognitive dimension : characteristics of the path taken : interpersonal distances with virtual humans (in m)', 'timeFrame': 'From enrollment to the end of the participation at maximum 30 days'}, {'measure': 'Action-related dimension : walking speed (measured in m/s)', 'timeFrame': 'From enrollment to the end of the participation at maximum 30 days'}], 'secondaryOutcomes': [{'measure': '" Montréal Cognitive Assesment " (MoCA)', 'timeFrame': 'On day 1'}, {'measure': '" 10-Meter Walking Test " (10MWT)', 'timeFrame': 'At day 1'}, {'measure': 'Balance test : ABC-scale', 'timeFrame': 'At day 1'}, {'measure': 'Balance test : "Berg Balance Scale" (BBS)', 'timeFrame': 'At day 1'}, {'measure': 'Balance test : "Time Up and Go" (TUG)', 'timeFrame': 'At day 1'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Traumatic Brain Injury']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria for Traumatic Brain Injury group :\n\n* 18 ≤ Age ≤ 55 years old\n* Male/female\n* Having suffered a first non-penetrating head injury\n* Moderate to severe severity with initial Glasgow Coma Scale score 5\\<GCS\\<13\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/s, able to walk at least 20 m without technical or human assistance, PM ≥ 300 m)\n* Able to maintain dynamic balance while standing (TUG\\<16s)\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/female\n* Able to walk (≥ 0.8 m/s, 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."}, 'identificationModule': {'nctId': 'NCT07230002', 'acronym': 'NAVIGO', 'briefTitle': 'Effects of Moderate/Severe Traumatic Brain Injury in the Subacute or Chronic Phase on Locomotor Strategies Involved in Navigation in Complex Virtual Environments', 'organization': {'class': 'OTHER', 'fullName': 'Pôle Saint Hélier'}, 'officialTitle': 'Effects of Moderate/Severe Traumatic Brain Injury in the Subacute or Chronic Phase on Locomotor Strategies Involved in Navigation in Complex Virtual Environments', 'orgStudyIdInfo': {'id': '2025-A00679-40'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single group', 'description': '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.', 'interventionNames': ['Other: Locomotion in a virtual reality setting']}], 'interventions': [{'name': 'Locomotion in a virtual reality setting', 'type': 'OTHER', 'description': 'Patients and participants will be asked to perform several walking/locomotion 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.', 'armGroupLabels': ['Single group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35043', 'city': 'Rennes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emilie Leblong', 'role': 'CONTACT', 'email': 'emilie.leblong@fondationsainthelier.com', 'phone': '+33299295043'}], 'facility': 'Fondation Saint Helier', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}], 'centralContacts': [{'name': 'Emilie Leblong, MD', 'role': 'CONTACT', 'email': 'emilie.leblong@fondationsainthelier.com', 'phone': '+33299295043'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pôle Saint Hélier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}