How moderate-to-severe brain injury affects walking and navigation in busy virtual environments

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

We will test whether people with moderate-to-severe traumatic brain injury navigate and walk differently in realistic virtual environments compared with healthy adults.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Pôle Saint Hélier (other)
• Locations: 1 site (Rennes)
• Trial ID: NCT07230002 on ClinicalTrials.gov

What this trial studies

Participants with a first non-penetrating moderate-to-severe traumatic brain injury (≥3 months post-injury) and age-matched healthy controls complete locomotion tasks inside immersive virtual environments that recreate everyday social navigation challenges. Gait, dynamic balance, and navigation choices are recorded while participants walk through simulated crowded or obstacle-filled scenes. Inclusion requires the ability to walk independently, maintain dynamic balance, and respond to simple questionnaires; detailed kinematic and behavioral measures will be compared between groups. The goal is to better characterize the locomotor strategies and difficulties that affect community mobility after moderate-to-severe head injury.

Who should consider this trial

Good fit: Adults 18–55 who had a first non-penetrating moderate-to-severe traumatic brain injury (initial GCS 5–12), are at least 3 months post-injury, can walk independently (≥0.8 m/s, ≥20 m) and maintain dynamic balance, and can answer simple questionnaires are ideal candidates.

Not a fit: People outside the 18–55 age range, with penetrating injuries, with very limited walking or balance ability, less than 3 months post-injury, or with cognitive inability to follow instructions are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the results could inform rehabilitation strategies and safety recommendations to help people with moderate-to-severe traumatic brain injury move more safely and confidently in daily life.

How similar studies have performed: Virtual reality approaches have shown promising results for studying gait and navigation after brain injury, but applying complex social navigation tasks specifically to moderate-to-severe TBI in subacute/chronic phases is relatively novel.

Eligibility 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.

Where this trial is running

Rennes

• Fondation Saint Helier — Rennes, France (RECRUITING)

Study contacts

• Study coordinator: Emilie Leblong, MD

Conditions: Traumatic Brain Injury