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

NCT ID: NCT07230002

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2026-10-30

Brief Summary

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.

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Single group

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.

Group Type: EXPERIMENTAL

Locomotion in a virtual reality setting

Intervention Type: OTHER

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.

Interventions

Locomotion in a virtual reality setting

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• 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

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

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pôle Saint Hélier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fondation Saint Helier

Rennes, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Emilie Leblong, MD

Role: CONTACT

emilie.leblong@fondationsainthelier.com

+33299295043

Facility Contacts

Emilie Leblong

Role: primary

emilie.leblong@fondationsainthelier.com

+33299295043

Other Identifiers

2025-A00679-40

Identifier Type: -

Identifier Source: org_study_id