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

Assessment of Robotic Assistance on Gait Parameters.

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Device: Exoskeleton for gait rehabilitation (Atalante)

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stéphanie Dehem; Phone Number: 00327649380; Email: stephanie.dehem@uclouvain.be

Study Locations

• Belgium
  • Bruxelles, Belgium, 1200
    • Recruiting
    • Cliniques Universitaires Saint-Luc
    • Contact: Stéphanie Dehem

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group.; Healthy subjects and brain damaged patients with gait disorder.	Device: Exoskeleton for gait rehabilitation (Atalante); Subjects will walk with different levels of assistance given by the robot.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Energy cost (J.kg/m)	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.	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Temporo-spatial parameters of gait: step length	Reflective landmarks positioned on precise anatomic sites were used to compute spatiotemporal variables. 8 infra-red camera are used to asess step length (m).	1 week
Temporo-spatial parameters of gait: stance phase	Reflective landmarks positioned on precise anatomic sites were used to compute spatiotemporal variables. 8 infra-red camera are used to assess stance phase (%).	1 week
Temporo-spatial parameters of gait: cadence	Reflective landmarks positioned on precise anatomic sites were used to compute spatiotemporal variables. 8 infra-red camera are used to assess cadence (step/min).	1 week
Segmental kinematics of gait (°)	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.	1 week
Muscle activation	Electrodes are placed on different muscles to record muscles activity.	1 week
Mechanical work (J.kg/m)	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)	1 week

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Investigators: Principal Investigator: Thierry Lejeune, Cliniques Universitaires Saint-Luc

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2021
• Primary Completion (Anticipated): December 21, 2023
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: December 22, 2021
• First Submitted That Met QC Criteria: February 21, 2022
• First Posted (Actual): March 3, 2022

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2021/4OCT/404

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No