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

Inclusion Criteria5

Unilateral major lower-limb amputation (transtibial or transfemoral)
Presence of persistent phantom limb pain, defined as daily pain intensity ≥ 3/10 on the Visual Analog Scale (VAS) during the baseline period
Regular daily use of a prosthetic limb (minimum 4 hours/day)
Adequate German language proficiency to understand and complete study questionnaires and follow study procedures
Ability to provide informed consent

Exclusion Criteria5

Unstable wound or skin condition at the residual limb
Inconsistent prosthetic use (less than daily or \< 4 hours/day)
Poorly fitting or non-functional prosthesis (as determined by study team)
Incapacity to provide informed consent (e.g., due to cognitive impairment or severe psychiatric illness)
Insufficient German language skills to comprehend study materials or complete assessments reliably

Print for Your Doctor

Interested in this trial?

Get notified about updates and connect with the research team.

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.