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

Stroke Clinical Trial

— MARAT  

Official title:

Assessment of Robotic Assistance on Gait Parameters.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05264103
• Other study ID #: 2021/4OCT/404
• Status: Recruiting
• Phase: N/A
• Start date: December 21, 2021
• Est. completion date: January 2024

Study information

• Verified date: April 2023
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Stéphanie Dehem
• Phone: 00327649380
• Email: stephanie.dehem[@]uclouvain.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2024
• Est. primary completion date: December 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Exoskeleton for gait rehabilitation (Atalante)
Subjects will walk with different levels of assistance given by the robot.

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint-Luc	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Muscle activation	Electrodes are placed on different muscles to record muscles activity.	1 week
Secondary	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