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Clinical Trials/NCT05264103
NCT05264103
Completed
Not Applicable

Assessment of Robotic Assistance on Gait Parameters.

Cliniques universitaires Saint-Luc- Université Catholique de Louvain1 site in 1 country10 target enrollmentDecember 21, 2021
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Enrollment
10
Locations
1
Primary Endpoint
Energy cost (J.kg/m)
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 21, 2021
End Date
December 21, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Temporo-spatial parameters of gait: step length(1 week)
  • Temporo-spatial parameters of gait: stance phase(1 week)
  • Temporo-spatial parameters of gait: cadence(1 week)
  • Segmental kinematics of gait (°)(1 week)
  • Muscle activation(1 week)
  • Mechanical work (J.kg/m)(1 week)

Study Sites (1)

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