Effects of Active Upper-Limb Exoskeleton Training in Simulated Hyper-Gravity on Fine Motor Performance, Brain-Muscle Connectivity, Cardiovascular System and Stress Responses in Real Hyper-Gravity (EGOS)
Effects of Active Upper-Limb Exoskeleton Training in Simulated Hyper-Gravity on Fine Motor Performance, Brain-Muscle Connectivity, Cardiovascular System and Stress Responses in Real Hyper-Gravity: the EGOS Pilot Study.
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Occitanie
-
Toulouse, Occitanie, France, 31400
- Medes - Imps
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Maximum weight of 90 kg
- Maximum sitting butt-to-shoulder distance of 70 cm
- Certified as healthy by a comprehensive clinical assessment
- Normal or corrected to normal vision
- Right-handed tested with Edinburgh-Handedness-Inventory-Test (≥6th percentile, on https://www.brainmapping.org/shared/Edinburgh.php)
- Non smokers
- No alcohol or drug dependence, no medical treatment on a regular basis
- Affiliated to a Social Security system and, for non-French resident, holding a European Health Insurance Card (EHIC) or a Global Health Insurance Card (GHIC).
- Free of any engagement during the study
- Test subjects must be able to understand and speak English
- Who agreed to take part in the study and signed the informed consent
Exclusion Criteria:
- Left-handed tested with Edinburgh-Handedness-Inventory-Test (<6th percentile)
- Subjects with experience in experiments on a short arm human centrifuge or under real hyper-gravity
- Non-tolerance to the centrifugation
- Any history or presence of clinically relevant chronic disease
- Refusal to give permission to contact his general practitioner,
- Subject who, in the judgment of the investigator, is likely to be non-compliant during the study, or unable to cooperate because of a language problem or poor mental development,
- Subject in the exclusion period of a clinical research,
- Subject who has received more than 6000 Euros within 12 months for being a research subject,
- Subject who cannot be contacted in case of emergency,
- Vulnerable people according to law "Code de la Santé Publique" (L1121-5 to L1121-8)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
No Intervention: Control
Untrained group
|
|
|
Experimental: Trained
Trained with the exoskeleton
|
Training to perform an aiming task under simulated hypergravity via an exoskeleton
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Task performance (movement accuracy)
Time Frame: From familiarisation sessions (Day 1 to Day 4) to testing day at Day 5.
|
Task performance (movement accuracy) is defined as the difference between the position touched on the screen and the position of the displayed target. The participants will be required to perform an aiming movement task using their right arm, directed toward a target.The participants will need to point to the center of the displayed target. |
From familiarisation sessions (Day 1 to Day 4) to testing day at Day 5.
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- 23-318
- ID-RCB Number: 2025-A01589-40 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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