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

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: Exoskeleton for gait rehabilitation (Atalante)

• Registration Number: NCT05264103
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-21
• Study First Submitted: 2021-12-22
• Study First Submitted QC: 2022-02-21
• Study First Posted: 2022-03-03
• Primary Completion: 2023-12-21
• Study Completion: 2023-12-21
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental group.	Exoskeleton for gait rehabilitation (Atalante)	Healthy subjects and brain damaged patients with gait disorder.

Primary Outcome Measures

Name	Time	Method
Energy cost (J.kg/m)	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 Outcome Measures

Name	Time	Method
Temporo-spatial parameters of gait: step length	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).
Temporo-spatial parameters of gait: stance phase	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 (%).
Temporo-spatial parameters of gait: cadence	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).
Segmental kinematics of gait (°)	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.
Muscle activation	1 week	Electrodes are placed on different muscles to record muscles activity.
Mechanical work (J.kg/m)	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)

Trial Locations

Locations (1)

Cliniques universitaires Saint-Luc; 🇧🇪 Bruxelles, Belgium