Effects of Moderate/Severe Traumatic Brain Injury in the Subacute or Chronic Phase on Locomotor Strategies Involved in Navigation in Complex Virtual Environments
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Perceptive dimension : Elements of the environment viewed : Distribution (in %)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Locomotion in a virtual reality setting (Other)
结局指标
主要结局
Perceptive dimension : Elements of the environment viewed : Distribution (in %)
时间窗: From enrollment to the end of the participation at maximum 30 days
Perceptive dimension : Elements of the environment viewed : duration of fixations (in milliseconds)
时间窗: From enrollment to the end of the participation at maximum 30 days
Action-related dimension : walking speed (measured in m/s)
时间窗: From enrollment to the end of the participation at maximum 30 days
Perceptive dimension : Elements of the environment viewed : Distance (in meters)
时间窗: 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)
时间窗: 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)
时间窗: From enrollment to the end of the participation at maximum 30 days
次要结局
- " Montréal Cognitive Assesment " (MoCA)(On day 1)
- " 10-Meter Walking Test " (10MWT)(At day 1)
- Balance test : ABC-scale(At day 1)
- Balance test : "Time Up and Go" (TUG)(At day 1)
- Balance test : "Berg Balance Scale" (BBS)(At day 1)