Suralis vibrotactile system for phantom limb pain after lower-limb amputation
Clinical Application Observation: Evaluation of Phantom Limb Pain After 3 Weeks of Use of a Feedback System Using Vibration (Suralis, Manufacturer: Saphenus)
This pilot will test whether wearing the Suralis vibration feedback system during walking reduces phantom limb pain in people with a unilateral lower-limb amputation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Median Academic / other |
| Locations | 1 site (Wiesbaden, Hesse) |
| Trial ID | NCT07324109 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-arm pilot where participants complete a 3-week baseline, 3 weeks of using the Suralis vibrotactile feedback system during daily ambulation, and a 3-week washout follow-up. The Suralis system uses a sensorized insole to detect pressure and activates thigh-mounted vibrotactile actuators with individually calibrated intensity and timing. Outcomes include daily VAS pain scores, gait tests (TUG, 6MWT), and validated questionnaires of function and quality of life collected at the study center. The device is CE-marked (Class IIa) and has been used without reported device-related adverse events in prior clinical use.
Who should consider this trial
Good fit: Ideal candidates are adults with a unilateral major lower-limb amputation who have persistent daily phantom limb pain (VAS ≥ 3/10), use a prosthesis at least 4 hours per day, speak German, and can give informed consent.
Not a fit: People with unstable residual limb wounds, inconsistent or insufficient prosthesis use, poor-fitting prostheses, or who cannot complete German-language assessments are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the Suralis system could provide a non-drug, wearable option to reduce phantom limb pain and improve walking function and quality of life for amputees.
How similar studies have performed: Small studies and case reports of vibrotactile sensory feedback or sensory substitution have shown promising pain or function signals, but larger controlled trials are still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Wiesbaden, Hesse
- MEDIAN Rehab Center Wiesbaden Sonnenberg — Wiesbaden, Hesse, Germany (Recruiting)
Study contacts
- Study coordinator: Johannes Schroeter, Dr. med.
- Email: johannes.schroeter@median-kliniken.de
- Phone: +49 611 575 811
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.