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Clinical Application Observation on the Evaluation of Phantom Limb Pain With the Suralis System
Sponsor: Median
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.
Official title: Clinical Application Observation: Evaluation of Phantom Limb Pain After 3 Weeks of Use of a Feedback System Using Vibration (Suralis, Manufacturer: Saphenus)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2025-04-01
Completion Date
2026-07-31
Last Updated
2026-01-07
Healthy Volunteers
No
Conditions
Interventions
Vibrotactile 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.
Locations (1)
MEDIAN Rehab Center Wiesbaden Sonnenberg
Wiesbaden, Hesse, Germany