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

NCT ID: NCT07278245

Last Updated: 2026-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-27

Study Completion Date

2026-01-27

Brief Summary

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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.

Detailed Description

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Conditions

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Motor Learning and Physiological Adaptation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Control

Untrained group

Group Type NO_INTERVENTION

No interventions assigned to this group

Trained

Trained with the exoskeleton

Group Type EXPERIMENTAL

Training with an exoskeleton

Intervention Type OTHER

Training to perform an aiming task under simulated hypergravity via an exoskeleton

Interventions

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Training with an exoskeleton

Training to perform an aiming task under simulated hypergravity via an exoskeleton

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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MEDES Institut de Médecine et de Physiologie Spatiales, Toulouse

UNKNOWN

Sponsor Role collaborator

Centre National d'Etudes Spatiales

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medes - Imps

Toulouse, Occitanie, France

Site Status

Countries

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France

Other Identifiers

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ID-RCB Number: 2025-A01589-40

Identifier Type: OTHER

Identifier Source: secondary_id

23-318

Identifier Type: -

Identifier Source: org_study_id

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