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

NCT05264103 | Completed

• 1 other identifier: 2021/4OCT/404
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (1)

Experimental group.

EXPERIMENTAL

Healthy subjects and brain damaged patients with gait disorder.

Device: Exoskeleton for gait rehabilitation (Atalante)

Interventions

Exoskeleton for gait rehabilitation (Atalante) DEVICE

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

Experimental group.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- Contraindication for the use of the robot Atalante

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Thierry Lejeune

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: March 3, 2022
• Study Start: December 21, 2021
• Primary Completion: December 21, 2023
• Study Completion: December 21, 2023
• Last Updated: December 11, 2024

Record last verified: 2024-12

Locations

BE (1)