Overview of an ongoing clinical trial on hand prostheses: Toward use of synergy-based prosthetic hands for activities of daily living by transradial amputees.

Abstract

Upper limb loss due to traumatic injury or disease poses significant challenges to autonomy, daily function, and workforce reintegration, profoundly impacting overall quality of life. While myoelectric prosthetic hands have the potential to restore dexterity, many users discontinue use due to limited functionality and durability.This manuscript describes the design and rationale of an ongoing clinical trial aimed at addressing these gaps in real-world settings. We searched for completed and ongoing clinical trials on ClinicalTrials.gov to study their structure and their gaps, and then we presented the protocol of our ongoing clinical trial. This protocol outlines a randomized crossover clinical trial enrolling 36 adults with upper limb loss to evaluate two multi-articulated myoelectric prosthetic hands. Our review of clinical trials revealed that the unique strength of our design is the integration of standardized laboratory tests, extended daily use, onboard usage data, and validated satisfaction surveys. We provided a detailed description of all design choices and rationale of the ongoing clinical study. The comparison between our design and the design of other studies indicates that our design is unique in the integration of biomechanical assessments, real-world usage monitoring, and user-reported outcomes. This clinical trial should be capable of assessing if one specific device design can offer clinically meaningful advantages over another. The design of our clinical trial could inform the design of clinical trials targeting the optimization of prostheses and their acceptance by prosthetic users.