Amputation Clinical Trial
Official title:
Restoration of Sensations From the Lost Limb to Amputees for Fall Avoidance, Regular Walking, Phantom Limb Pain Diminishment and Embodiment of Prosthesis
Lower limb amputees suffer complete lack of sensory feedback of current available prostheses,
which excludes the central nervous system from the correct sensory-motor integration. It
causes serious problems as: falls due to unexpected perturbations, asymmetric walking, low
mobility, higher power consumption, feeling the prosthesis as a foreign body, high cognitive
burden, and phantom limb pain occurrence.
Investigators will provide amputees with a prosthesis restoring sensory feedback and will
assess its benefits on the users.
The clinical investigation described here aims at evaluating the benefit of a lower limb
prosthesis providing sensory feedback (bidirectional prosthesis), in selected transfemoral
amputees. The device is constituted by i) Rheo Knee XC, Pro Flex foot and customized
socket/liner structure from OSSUR. Rheo Knee embedded already an encoder coupled with a
Bluetooth unit, which is used to make communication with devices external to the knee itself;
ii) nerve stimulating system constituted by implantable intraneural electrodes from IMTEK,
iii) an external neurostimulator from AXONIC, and iv) sensorized sole from SensArs
Neuroprosthetics to apply under the prosthetic foot and driving the stimulating system. The
readout of the sensorized insole are transmitted via Bluetooth, together with the encoder
readout, to an external controller, which transduces it in parameters of stimulation. These
parameters are sent to the stimulator, which injects current into the intraneural electrodes.
As final result, the subject perceives sensory feedback from the prosthesis when using it.
Investigators call SENSY the sensory feedback restoration system. The subjects will use the
prosthesis with and without sensory feedback to execute walking tasks. The average change of
kinematics (including falls), metabolic cost, embodiment, and cognitive burden (EEG) when
intraneural stimulation is provided will be compared to the case in which there is no sensory
feedback. Standard clinical tests (as PEQ and CB&MS) will be executed with and without
sensory feedback. Also, when the subjects will report attacks of phantom pain, they will
undergo a 10-minutes-stimulation session. Only stimulation without prosthesis is used in this
intervention.
Finally, imaging of the cortical activity will be executed through functional magnetic
resonance imaging (fMRI). This procedure will be only observational since no prosthesis or
sensory feedback will be used by the subjects.
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