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

NCT07324109 | Recruiting

• 1 other identifier: PhantomLimbPain
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Phantom limb pain; Vibrotactile feedback; Lower limb amputation; Suralis system; Pain management

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (VAS)

  Scores range from 0 to 100 mm, where 0 mm = "no phantom pain" and 100 mm = "worst imaginable phantom pain"; higher scores indicate greater pain intensity.

  Baseline (t1), end of 3-week intervention (t3), and 3-week follow-up (t4) - assessed via daily VAS entries averaged per time point.

Secondary Outcomes (3)

• German Pain Questionnaire DSF - subscales

  Baseline (t1), end of 3-week intervention (t3), and 3-week follow-up (t4) - completed in person at study center.

• Timed Up-and-Go (TUG) test

  Baseline (t1), end of 3-week intervention (t3), and 3-week follow-up (t4) - performed once per visit at study center.

• 6-Minute Walk Test (6MWT)

  Baseline (t1), end of 3-week intervention (t3), and 3-week follow-up (t4) - performed once per visit at study center; distance in meters recorded.

Study Arms (1)

Intervention with Suralis System

EXPERIMENTAL

All participants receive a 3-week intervention with the Suralis vibrotactile feedback system, which provides real-time pressure-based sensory feedback via a sensorized insole and thigh-mounted vibrating cuff, calibrated individually via smartphone app to support pain reduction and gait stability.

Device: Vibrotactile sensory feedback

Interventions

Vibrotactile sensory feedback DEVICE

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.

Intervention with Suralis System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Median: lead

Study Sites (1)

MEDIAN Rehab Center Wiesbaden Sonnenberg

Wiesbaden, Hesse, 65191, Germany

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Phantom Limb; Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Central Study Contacts

Johannes Schroeter, Dr. med.

CONTACT

+49 611 575 811; johannes.schroeter@median-kliniken.de

Natascha Raisig, M. Sc.

CONTACT

+49 611 575 87294; natascha.raisig@median-kliniken.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med. Johannes Schroeter

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 7, 2026
• Study Start: April 1, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)