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Clinical Trials/NCT07278245
NCT07278245
Completed
Not Applicable

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.

Centre National d'Etudes Spatiales1 site in 1 country12 target enrollmentStarted: October 27, 2025Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
12
Locations
1
Primary Endpoint
Task performance (movement accuracy)

Overview

Brief Summary

The aim of the study presented here is to assess the effects of exoskeleton training on performance in a real hypergravity situation. In particular, it will analyze fine motor control, autonomic nervous system regulation and metabolic responses. To this end, the study will compare two groups during a pointing exercise in a centrifuge (hypergravity). One group will have been trained to do this exercise using an exoskeleton, while the other will have been familiarized with the task without the exoskeleton. It will assess whether the exoskeleton can be an effective and accessible training tool for astronauts.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

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)

Arms & Interventions

Control

No Intervention

Untrained group

Trained

Experimental

Trained with the exoskeleton

Intervention: Training with an exoskeleton (Other)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (1)

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