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

November 14, 2025 updated by: Pôle Saint Hélier
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Perceptive dimension : Elements of the environment viewed : Distribution (in %)
Time Frame: From enrollment to the end of the participation at maximum 30 days
From enrollment to the end of the participation at maximum 30 days
Perceptive dimension : Elements of the environment viewed : Distance (in meters)
Time Frame: From enrollment to the end of the participation at maximum 30 days
From enrollment to the end of the participation at maximum 30 days
Perceptive dimension : Elements of the environment viewed : duration of fixations (in milliseconds)
Time Frame: From enrollment to the end of the participation at maximum 30 days
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)
Time Frame: From enrollment to the end of the participation at maximum 30 days
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)
Time Frame: From enrollment to the end of the participation at maximum 30 days
From enrollment to the end of the participation at maximum 30 days
Action-related dimension : walking speed (measured in m/s)
Time Frame: From enrollment to the end of the participation at maximum 30 days
From enrollment to the end of the participation at maximum 30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
" Montréal Cognitive Assesment " (MoCA)
Time Frame: On day 1
On day 1
" 10-Meter Walking Test " (10MWT)
Time Frame: At day 1
At day 1
Balance test : ABC-scale
Time Frame: At day 1
At day 1
Balance test : "Berg Balance Scale" (BBS)
Time Frame: At day 1
At day 1
Balance test : "Time Up and Go" (TUG)
Time Frame: At day 1
At day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pôle Saint Hélier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 30, 2025

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

October 30, 2026

Study Registration Dates

First Submitted

September 25, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Actual)

November 17, 2025

Study Record Updates

Last Update Posted (Actual)

November 17, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-A00679-40

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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