Clinical Application Observation: Evaluation of Phantom Limb Pain After 3 Weeks of Use of a Feedback System Using Vibration (Suralis, Manufacturer: Saphenus)

What this Trial Is About

This research aims to evaluate whether the Suralis vibration-based feedback device can reduce phantom limb pain in people with lower-leg amputations. The study focuses on individuals with unilateral major lower-limb amputation who experience persistent phantom pain. It is an observational, prospective pilot study designed to explore the short-term effects of this device on pain intensity, walking ability, and quality of life without using a control group or randomization. Participants will use the Suralis system, which includes a sensorized insole with pressure sensors and a vibrating thigh cuff, for three weeks. The device provides real-time sensory feedback calibrated individually through a smartphone app to match each user's gait and sensation. The study includes a three-week baseline period, three weeks of active device use, and a three-week follow-up phase to assess lasting effects. During the study, participants will report daily pain levels using a visual analogue scale and complete functional tests like the Timed Up-and-Go and 6-Minute Walk Test at the study center. Questionnaires on pain and quality of life will also be administered. Device usage is monitored via Bluetooth, and no additional treatments are given. The research team will analyze changes in pain and function over the study period, with participation lasting a total of nine weeks including baseline and follow-up.

Clinical Application Observation on the Evaluation of Phantom Limb Pain With the Suralis System