Actively Recruiting

Phase Not Applicable
Age: 18Years - 55Years
All Genders
Healthy Volunteers
NCT07230002

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

Led by Pôle Saint Hélier · Updated on 2025-11-17

40

Participants Needed

1

Research Sites

47 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

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

Who Can Participate

Age: 18Years - 55Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 55 years old
  • Male or female
  • For traumatic brain injury group: first non-penetrating head injury with Glasgow Coma Scale score between 6 and 12
  • In subacute or chronic phase at least 3 months after injury (for traumatic brain injury group)
  • Able to walk at least 20 meters without technical or human assistance with a walking speed of 0.8 m/s or more and a minimum 300 m walking perimeter
  • Able to maintain dynamic balance while standing with Timed Up and Go test under 16 seconds
  • Able to answer simple questionnaires as judged by the investigator
  • Provided free, informed, written consent
  • Registered with a social security system
  • Individuals under legal guardianship may be eligible (traumatic brain injury group only)
Not Eligible

You will not qualify if you...

  • Persons under legal protection other than guardianship or unable to give consent (traumatic brain injury group)
  • Severe psychiatric care ongoing that may affect study participation
  • Neurological signs of neurodegenerative disease causing gait disturbance
  • Musculoskeletal disorders affecting walking ability
  • Uncontrolled epilepsy at time of inclusion
  • Visual impairments making participation impossible as judged by investigator
  • Pregnant, parturient, or breastfeeding women
  • Participation in another ongoing human research protocol
  • For healthy controls: fatigue, trauma, or condition affecting mobility, posture, balance, or walking
  • Persons deprived of liberty by judicial or administrative decision
  • Persons under legal protection or unable to give consent
  • Severe psychiatric treatment or admitted to health or social care facility for non-research reasons

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fondation Saint Helier

Rennes, France, 35043

Actively Recruiting

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Research Team

E

Emilie Leblong, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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