Stopped: recruitment rate of patients was not sufficient during COVID-19; problems with the quality of the primary outcome data collected
Prosthetics research has grown recently, focusing on bionic approaches that restore bodily functions with technical aids. One method involves using prostheses with feedback systems, which measure physical parameters and provide additional information to the user. Saphenus has developed a feedback system called SuralisĀ© that transfers pressure signals from the prosthetic sole to another body region. This clinical investigation aimed to determine if this system improves gait stability and walking. The study analyzed changes in gait and functional balance and gathered patient-reported measures to evaluate the quality of life. This research was open to individuals who have undergone below-knee amputation but no targeted re-innervation surgery and use prosthetics. Participants received the SuralisĀ© feedback system, and the investigators assessed their walking activities. The system measures prosthetic foot sole pressure and converts it into digital signals, triggering vibration stimuli during the stance phase of walking. The investigators collected gait analyses and patient feedback to assess the impact of the feedback system on prosthetic management. The results will help us understand the benefits and effectiveness of this technology for people with amputation.
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Affected leg stance time treatment-change difference
Timeframe: Difference between the within-period changes of the 60-day control (C) and vibration (V) periods of the randomized controlled crossover trial, i.e., V(post - pre) - C(post - pre); three tries each assessment day