Amputation, Traumatic Clinical Trial
Official title:
A Feasibility Study to Assess Safety and Functionality of Implantable Myoelectric Sensors for Upper Extremity Prosthetic Control in Transradial Amputees
This study will evaluate the feasibility of using implanted myoelectric sensors (IMES) to control an electromechanical prosthetic wrist and hand.
The study assesses the feasibility of an advanced prosthesis control system aimed at
development of a more intuitive and functional prosthetic device. Tiny (2.5 mm by 16 mm)
Implantable Myoelectric Sensors (IMES) will be implanted into the residual forearm muscles
of three transradial amputee subjects. These devices wirelessly transmit electrical muscle
signals to an electromechanical prosthetic wrist and hand.
Following a two-week recovery from implantation of six to eight IMES into residual forearm
muscles, subjects will initiate seven months of training. Subjects first train for
approximately a month using a bench-top IMES system. When they receive their custom-fit IMES
Prosthesis (including electromechanical wrist and hand) subjects initiate six months of
additional training. Subjects will then be given the option to use the IMES Prosthesis for
another sixteen months. The usability and functionality of the prosthetic system will be
evaluated throughout the study.
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