RecruitingNot ApplicableNCT07324109

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

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

Sponsor

Median

Enrollment

20 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

Lower Limb Amputation Below Knee Lower Limb Amputation Above Knee Phantom Limb Pain After Amputation Lower Limb Amputation Knee

Summary

This study tests whether a vibration-based feedback device (Suralis) can reduce phantom limb pain in people with lower-leg amputations over 3 weeks. Participants wear the device daily and report pain levels, walking ability, and quality of life - with no known risks, as it's a CE-certified medical device. If pain improves, the study team will help participants apply for insurance coverage to keep using the system long-term. The goal is to offer a simple, non-drug option that may help ease chronic pain and improve daily function for amputees. Participation is voluntary and can be stopped anytime without affecting medical care.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Vibrotactile sensory feedback for people with lower limb amputation above knee, lower limb amputation below knee, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEVibrotactile sensory feedback

The Suralis system delivers real-time vibrotactile feedback via four pressure sensors embedded in a prosthetic insole, each mapped to a corresponding vibration motor on a thigh cuff. Participants wear the device during daily ambulation for 3 weeks. Vibration parameters (threshold, intensity, duration, spatial mapping) are individually calibrated via a smartphone app to match each user's sensory perception and gait pattern. The system operates autonomously, requires daily charging, and logs usage data via Bluetooth. No additional therapy or medication is administered alongside the device. The intervention aims to modulate cortical reorganization and reduce phantom limb pain while improving gait confidence and safety, particularly under non-visual conditions (e.g., stepping backward or sideways). The device is CE-marked (UDI: FBS 1 912012142) and classified as a Class IIa medical device under EU MDR 2017/746.