Clinical Application Observation on the Evaluation of Phantom Limb Pain With the Suralis System
NCT ID: NCT07324109
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2025-04-01
2026-07-31
Brief Summary
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Detailed Description
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The study protocol includes a 3-week baseline phase to confirm persistent phantom pain (VAS ≥ 3/10 daily), followed by 3 weeks of active intervention, and a 3-week washout/follow-up phase to assess sustainability of effects. All assessments are conducted at the study center and include standardized functional tests (TUG, 6MWT), validated German-language questionnaires (DSF, VR-12, DASS, FW7, GCPS), and daily VAS entries captured via paper-based diaries. The system's CE-marked status (UDI: FBS 1 912012142) confirms conformity with EU MDR 2017/746 for Class IIa medical devices; no adverse events related to device use have been reported in prior clinical use. The study design incorporates no control group or randomization, reflecting its exploratory, real-world application focus. Statistical analysis will be descriptive and exploratory, with non-parametric methods applied to ordinal outcomes (Friedman test) and parametric or non-parametric repeated-measures analyses for continuous variables, depending on distribution. No blinding is feasible due to the nature of the intervention. All procedures comply with the Declaration of Helsinki and have been reviewed by the Ethics Committee of the Hessian Medical Association (approval pending).
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intervention with Suralis System
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Median
OTHER
Responsible Party
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Johannes Schroeter
Dr. med. Johannes Schroeter
Locations
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MEDIAN Rehab Center Wiesbaden Sonnenberg
Wiesbaden, Hesse, Germany
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Related Info
Other Identifiers
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PhantomLimbPain
Identifier Type: -
Identifier Source: org_study_id
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