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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07230002
Acronym
NAVIGO
Enrollment
40
Registered
2025-11-17
Start date
2027-01-04
Completion date
2028-02-28
Last updated
2026-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

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.

Interventions

OTHERLocomotion 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.

Sponsors

Pôle Saint Hélier
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frameDescription
" Montréal Cognitive Assesment " (MoCA)On day 1
" 10-Meter Walking Test " (10MWT)At day 1
Balance test : ABC-scaleAt day 1
Balance test : "Berg Balance Scale" (BBS)At day 1Balance test: Berg Balance Scale (BBS), 14-item scale with a total score ranging from 0 (worst balance) to 56 (best balance); higher scores indicate better balance.
Balance test : "Time Up and Go" (TUG)At day 1Balance test: Timed Up and Go (TUG), time to complete the test measured in seconds; lower times indicate better functional mobility and balance, whereas longer times indicate poorer mobility and increased fall risk.

Countries

France

Contacts

CONTACTEmilie Leblong, MD
emilie.leblong@fondationsainthelier.com+33299295043

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026