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

NCT07230002 | Recruiting

• 1 other identifier: 2025-A00679-40
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• Perceptive dimension : Elements of the environment viewed : Distribution (in %)

  From enrollment to the end of the participation at maximum 30 days

• Perceptive dimension : Elements of the environment viewed : Distance (in meters)

  From enrollment to the end of the participation at maximum 30 days

• Perceptive dimension : Elements of the environment viewed : duration of fixations (in milliseconds)

  From enrollment to the end of the participation at maximum 30 days

• Cognitive dimension : characteristics of the path taken : length of the path taken (in meters)

  From enrollment to the end of the participation at maximum 30 days

• Cognitive dimension : characteristics of the path taken : interpersonal distances with virtual humans (in m)

  From enrollment to the end of the participation at maximum 30 days

• Action-related dimension : walking speed (measured in m/s)

  From enrollment to the end of the participation at maximum 30 days

Secondary Outcomes (5)

• " Montréal Cognitive Assesment " (MoCA)

  On day 1

• " 10-Meter Walking Test " (10MWT)

  At day 1

• Balance test : ABC-scale

  At day 1

• Balance test : "Berg Balance Scale" (BBS)

  At day 1

• Balance test : "Time Up and Go" (TUG)

  At day 1

Study Arms (1)

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.

Other: Locomotion in a virtual reality setting

Interventions

Locomotion in a virtual reality setting 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.

Single group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ≤ 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
• ≤ 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

You may not qualify if:

• \- 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 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.

Sponsors & Collaborators

• Pôle Saint Hélier: lead

Study Sites (1)

Fondation Saint Helier

Rennes, 35043, France

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Locomotion

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Movement; Physiological Phenomena; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Emilie Leblong, MD

CONTACT

+33299295043; emilie.leblong@fondationsainthelier.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: November 17, 2025
• Study Start: November 30, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

FR (1)