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Completed

NCT Number: NCT05264103

Assessment of Robotic Assistance on Gait Parameters Among Healthy Subjects and Brain Damaged Patients

The main objective of this study is to quantitatively assess the robotic assistance given by an exoskeleton on patients gait parameters. Patients will be asked to walk with- and without the exoskeleton on a treadmill. During the study, the biomechanical and the energy consumption will be assessed.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hemiparesis due to stroke
  • Min 18 years
  • Time since stroke > 15 days
  • Ability to understand instructions
  • Ability to do gait analysis on the treadmill

Exclusion criteria

  • Contraindication for the use of the robot Atalante

Treatment and study plan

Exoskeleton for gait rehabilitation (Atalante)

Device

Subjects will walk with different levels of assistance given by the robot.

Primary outcomes

  1. Energy cost (J.kg/m)

    Time frame: 1 week

    A nasal mask is fitted to the subject to measure oxygen consumption (VO2) and carbon dioxide production (VCO2). The ratio between VCO2 and VO2 is used to calculate the respiratory exchange ratio (RER). The Joules of energy expended per liter of oxygen consumed were computed depending on the RER. RER is assessed in a standing and walking condition. Finally, the energy cost is obtained by the ratio "walking expended minus standing'' divided by speed.

Secondary outcomes

  1. Temporo-spatial parameters of gait: step length

    Time frame: 1 week

    Reflective landmarks positioned on precise anatomic sites were used to compute spatiotemporal variables. 8 infra-red camera are used to asess step length (m).

  2. Temporo-spatial parameters of gait: stance phase

    Time frame: 1 week

    Reflective landmarks positioned on precise anatomic sites were used to compute spatiotemporal variables. 8 infra-red camera are used to assess stance phase (%).

  3. Temporo-spatial parameters of gait: cadence

    Time frame: 1 week

    Reflective landmarks positioned on precise anatomic sites were used to compute spatiotemporal variables. 8 infra-red camera are used to assess cadence (step/min).

  4. Segmental kinematics of gait (°)

    Time frame: 1 week

    Reflective landmarks positioned on precise anatomic sites were used to compute kinematic variables. Data from landmarks are collected with 8 infra-red camera. From Euler angles, it allowed the computation of angular displacements of the pelvis, hip, knee and ankle in the three planes of space.

  5. Muscle activation

    Time frame: 1 week

    Electrodes are placed on different muscles to record muscles activity.

  6. Mechanical work (J.kg/m)

    Time frame: 1 week

    The total positive mechanical work performed by the muscles during gait is calculated by the sum of external work (performed to move the body center of mass) and internal work (performed to move the body segments relative to the body center of mass)

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study title

Assessment of Robotic Assistance on Gait Parameters.

Acronym: MARAT

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 3, 2022
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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