Condition: Amputees · Sponsor: University of Pisa
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 simultaneous delivery of multiple stimuli may confuse or discomfort the user or they are well integrated by the sensitive system improving the experience of tactile sensation. This is a pilot, open-label study, meaning that both the researchers and the participants will be aware of the different phases of the study. The study population will include individuals with unilateral transradial upper-limb loss, either acquired or congenital. The planned sample size is 9 participants who meet the inclusion and exclusion criteria and who provide written informed consent to take part in the study. The stu…
This description comes directly from the study's public registry record.
Valentina Azzollini, MD · +39 050996734 · valentina.azzollini@unipi.it
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| Department of Neurorehabilitation, Univeristy Hospital of Pisa | Pisa, PI, Italy | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07418645