Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-25 @ 3:57 AM
NCT ID:
NCT07230002
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT07230002
Study Brief:
Protocol Section:
NCT07230002