Effects of Moderate/Severe Traumatic Brain Injury in the Subacute or Chronic Phase on Locomotor Strategies Involved in Navigation in Complex Virtual Environments (NAVIGO)

Pôle Saint Hélier

Status: Enrolling

Conditions: Traumatic Brain Injury

Treatments: Other: Locomotion in a virtual reality setting

Study type: Interventional

Funder types: Other

Identifiers

NCT07230002

2025-A00679-40

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Traumatic Brain Injury group :

• 18 ≤ Age ≤ 55 years old
• Male/female
• Having suffered a first non-penetrating head injury
• Moderate to severe severity with initial Glasgow Coma Scale score 5<GCS<13
• In the subacute or chronic phase (≥ 3 months at the date of the experiment, relative to the date of the injury)
• Able to walk (10WMT speed ≥ 0.8 m/s, able to walk at least 20 m without technical or human assistance, PM ≥ 300 m)
• Able to maintain dynamic balance while standing (TUG<16s)
• Able to answer simple questionnaires, according to the investigator's judgment
• Having given their free, informed, expressed (written) consent
• Registered with a social security system
• Individuals under legal protection measures such as guardianship may be eligible

Inclusion Criteria for healthy control group :

• 18 ≤ Age ≤ 55 years old
• Male/female
• Able to walk (≥ 0.8 m/s, able to walk at least 20 m without technical or human assistance, PM ≥ 300 m)
• Able to answer simple questionnaires, according to the investigator's judgment
• Having given free, informed, expressed (written) consent
• Registered with a social security system

Exclusion Criteria specific to patients in the traumatic brain injury group :

- Person under legal protection (excluding guardianship) or unable to express consent

Exclusion Criteria for both groups :

• Severe patho-psychiatric care underway, which may impact the conduct of the protocol, at the investigator's discretion
• Presence of neurological signs suggestive of a neurodegenerative disease responsible for gait disturbance (Parkinson's syndrome, Alzheimer's disease, etc.)
• Individuals with musculoskeletal disorders that impact their locomotor abilities
• Presence of uncontrolled epilepsy at the time of inclusion
• Presence of visual impairments that make experimentation impossible, at the discretion of the investigator
• Pregnant, parturient, or breastfeeding women
• Participants in another ongoing research protocol involving human subjects

Exclusion Criteria for healthy control group :

• Presence of fatigue, trauma, or a condition affecting mobility, posture, balance, or walking
• Persons deprived of their liberty by a judicial or administrative decision
• Persons deprived of their liberty by judicial or administrative decision
• Persons under legal protection (guardianship, curatorship, judicial protection) or unable to express their consent
• Persons undergoing severe psychiatric treatment or admitted to a health or social care facility for purposes other than research.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Single group

Experimental 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.

Treatment:

Other: Locomotion in a virtual reality setting