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

Обзор

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.

Вмешательства

• Другое 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

Первичные конечные точки

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

Вторичные конечные точки (5)

• " Montréal Cognitive Assesment " (MoCA) [Срок оценки: On day 1]
• " 10-Meter Walking Test " (10MWT) [Срок оценки: At day 1]
• Balance test : ABC-scale [Срок оценки: At day 1]
• Balance test : "Berg Balance Scale" (BBS) [Срок оценки: At day 1]
• Balance test : "Time Up and Go" (TUG) [Срок оценки: At day 1]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Франция · 1 центр

• Fondation Saint Helier — Rennes

Идентификаторы

NCT: NCT07230002 · 2025-A00679-40

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗