Suralis vibrotactile system for phantom limb pain after lower-limb amputation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.