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Evaluation of a Multimodal Tactile Feedback System for Upper Limb-loss Users: Embodiment and Performance

RecruitingNAAges 18 Years - 80 YearsAllUniversity of Pisa
NCT07418645 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The aim of this study is to evaluate the effect of integrating tactile feedback systems into a robotic upper-limb prosthesis. These systems deliver pressure stimuli (through small silicone chambers that inflate), vibration stimuli (through small circular actuators), or a combination of both to the arm, in order to improve the feeling of owning and controlling the artificial hand. In this way, when the robotic hand touches, grasps, and holds an object, the user receives sensory feedback that may make prosthesis use more natural, intuitive, and functional in everyday life. This is expected to improve the sense of bodily integration of the prosthesis, particularly by enhancing the perception of owning the bionic limb and the feeling of control over it, thereby improving the ability to perform daily activities with the prosthesis. In addition, the study aims to investigate whether the simul

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📋 Eligibility rules (as published)
Inclusion Criteria: * Presence of a stump at the transradial level * Active lifestyle (i.e., K-level K4, according to Medicare functional level classification) * Ability to understand and provide Informed Consent to participate in the study - Ability to participate in experimental acquisitions Exclusion Criteria: * Bilateral transradial amputation * Learning disabilities * Inability to understand the informed consent form * History or evidence of any medical, neurological or psychiatric conditions, which may affect brain function, metabolism, balance or motion, perception, representing, thus, a contraindication to the study (also stump pain or tenderness), other than the medical conditions or pathologies that have caused the upper-limb amputation * Hypertension, cardiovascular disease, and other endocrine diseases, neuromuscular diseases, malignancies * Vision and/or hearing problems severe enough to interfere with experimental procedures * Carrier of infectious diseases * Alcoholism or other substance abuse
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What it tests

  • Pressure and vibrotactile feedbak
  • Pressure feedback
  • Vibrotactile feedback
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Where

1 site
Department of Neurorehabilitation, Univeristy Hospital of Pisa
Pisa, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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