Traumatic Brain InjuryNAVIGONCT07230002
Effects of Moderate/Severe Traumatic Brain Injury in the Subacute or Chronic Phase on Locomotor Strategies Involved in Navigation in Complex Virtual Environments
A study testing Locomotion in a virtual reality setting in people with Traumatic Brain Injury, run by Pôle Saint Hélier at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Locomotion in a virtual reality setting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jan 2027to 28 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
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- 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 specific to patients in the traumatic brain injury group :
- Person under legal protection (excluding guardianship) or unable to express consent
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Fondation Saint Helier
Rennes, 35043
Emilie Leblong, +33299295043, emilie.leblong@fondationsainthelier.com
About this study
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
- Being tested
- Locomotion in a virtual reality setting
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Locomotion in a virtual reality settingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Locomotion in a virtual reality setting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceptive dimension : Elements of the environment viewed : Distribution (in %)
Measured: From enrollment to the end of the participation at maximum 30 days
Perceptive dimension : Elements of the environment viewed : Distance (in meters)
Measured: From enrollment to the end of the participation at maximum 30 days
Perceptive dimension : Elements of the environment viewed : duration of fixations (in milliseconds)
Measured: 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)
Measured: 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)
Measured: From enrollment to the end of the participation at maximum 30 days
Action-related dimension : walking speed (measured in m/s)
Measured: From enrollment to the end of the participation at maximum 30 days
Secondary outcomes (5)
" Montréal Cognitive Assesment " (MoCA)
Measured: On day 1
" 10-Meter Walking Test " (10MWT)
Measured: At day 1
Balance test : ABC-scale
Measured: At day 1
Balance test : "Berg Balance Scale" (BBS)
Balance 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.
Measured: At day 1
Balance test : "Time Up and Go" (TUG)
Balance 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.
Measured: At day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start4 Jan 2027 (estimated)
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pôle Saint Hélier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07230002
- Sponsor's protocol ID
- 2025-A00679-40
- Acronym
- NAVIGO
- Status last verified
- Sep 2026
- First submitted
- 25 Sep 2025
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Moderate/Severe Traumatic Brain Injury in the Subacute or Chronic Phase on Locomotor Strategies Involved in Navigation in Complex Virtual Environments
- ClinicalTrials.gov ID
- NCT07230002
- Acronym / sponsor ID
- NAVIGO / 2025-A00679-40
- Conditions
- Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Pôle Saint HélierUniversity, hospital or other
- Study start
- 4 Jan 2027 (estimated)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group | Experimental | Other: Locomotion in a virtual reality settingPatients 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Locomotion in a virtual reality settingPatients 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. | Other | Single group |
Primary outcome
Perceptive dimension : Elements of the environment viewed : Distribution (in %)
Time frame: 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
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
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
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
Action-related dimension : walking speed (measured in m/s)
Time frame: From enrollment to the end of the participation at maximum 30 days
5 secondary outcomes
" Montréal Cognitive Assesment " (MoCA)
Time frame: On day 1
" 10-Meter Walking Test " (10MWT)
Time frame: At day 1
Balance test : ABC-scale
Time frame: At day 1
Balance test : "Berg Balance Scale" (BBS)
Time frame: At day 1
Balance test : "Time Up and Go" (TUG)
Time frame: At day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Locomotion in a virtual reality setting in people with Traumatic Brain Injury, run by Pôle Saint Hélier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emilie Leblong, MD (+33299295043, emilie.leblong@fondationsainthelier.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceptive dimension : Elements of the environment viewed : Distribution (in %) (time frame: From enrollment to the end of the participation at maximum 30 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.