The SoftHand Pro: Functional evaluation of a novel, flexible, and robust myoelectric prosthesis.

Roughly one quarter of active upper limb prosthetic technology is rejected by the user, and user surveys have identified key areas requiring improvement: function, comfort, cost, durability, and appearance. Here we present the first systematic, clinical assessment of a novel prosthetic hand, the SoftHand Pro (SHP), in participants with transradial amputation and age-matched, limb-intact participants. The SHP is a robust and functional prosthetic hand that minimizes cost and weight using an underactuated design with a single motor. Participants with limb loss were evaluated on functional clinical measures before and after a 6-8 hour training period with the SHP as well as with their own prosthesis; limb-intact participants were tested only before and after SHP training. Participants with limb loss also evaluated their own prosthesis and the SHP (following training) using subjective questionnaires. Both objective and subjective results were positive and illuminated the strengths and weaknesses of the SHP. In particular, results pre-training show the SHP is easy to use, and significant improvement in the Activities Measure for Upper Limb Amputees in both groups following a 6-8 hour training highlights the ease of learning the unique features of the SHP (median improvement: 4.71 and 3.26 and p = 0.009 and 0.036 for limb loss and limb-intact groups, respectively). Further, we found no difference in performance compared to participant's own commercial devices in several clinical measures and found performance surpassing these devices on two functional tasks, buttoning a shirt and using a cell phone, suggesting a functional prosthetic design. Finally, improvements are needed in the SHP design and/or training in light of poor results in small object manipulation. Taken together, these results show the promise of the SHP, a flexible and adaptive prosthetic hand, and pave a path forward to ensuring higher functionality in future.