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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorPôle Saint Hélier

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Locomotion in a virtual reality setting

    Other intervention

    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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Single groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Perceptive dimension : Elements of the environment viewed : Distribution (in %)

Time frame
From enrollment to the end of the participation at maximum 30 days
2

Perceptive dimension : Elements of the environment viewed : Distance (in meters)

Time frame
From enrollment to the end of the participation at maximum 30 days
3

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
4

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

Secondary outcomes

1

" Montréal Cognitive Assesment " (MoCA)

Time frame
On day 1
2

" 10-Meter Walking Test " (10MWT)

Time frame
At day 1
3

Balance test : ABC-scale

Time frame
At day 1
4

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.

Time frame
At day 1

Other outcomes

Sponsors and contacts

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