Multimodal tactile feedback for upper-limb prostheses: embodiment and performance
ENG: Evaluation of the Effectiveness of a Feedback Device Fully Integrated Within a Prosthesis for Users With Upper Limb Amputation. IT: Valutazione Dell'Efficacia di un Dispositivo di Feedback Completamente Integrato All'Interno di Una Protesi, Per Utenti Che Presentano Amputazione Dell'Arto Superiore.
This tests whether adding pressure and vibration feedback to a robotic forearm prosthesis helps people with transradial amputations feel and control the artificial hand more naturally.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 9 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Pisa Academic / other |
| Locations | 1 site (Pisa, PI) |
| Trial ID | NCT07418645 on ClinicalTrials.gov |
What this trial studies
The study fits small inflatable pressure chambers and vibrating actuators to the residual arm to deliver pressure, vibration, or both while participants use a robotic hand. Participants perform functional tasks while researchers measure sense of ownership, perceived control, task performance, and any discomfort or confusion from combined stimuli. The protocol compares single-mode (pressure or vibration) versus combined feedback to see which produces the best embodiment and functional outcomes. Enrollment is limited to unilateral transradial amputees with an active (K4) lifestyle at the University Hospital of Pisa.
Who should consider this trial
Good fit: Ideal candidates are adults with a unilateral transradial amputation, an active (K4) functional level, and the ability to understand consent and participate in experimental sessions.
Not a fit: Patients unlikely to benefit include those with bilateral transradial amputation, significant cognitive, vision, or hearing impairments, uncontrolled medical or neurological conditions, severe stump pain, or other exclusionary comorbidities.
Why it matters
Potential benefit: If successful, this could make prosthesis use feel more natural and improve the ability to perform daily activities by restoring touch-like feedback.
How similar studies have performed: Previous studies using vibrotactile or pressure feedback have shown promising improvements in prosthesis control and embodiment, but simultaneous multimodal integration is less well established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Presence of a stump at the transradial level * Active lifestyle (i.e., K-level K4, according to Medicare functional level classification) * Ability to understand and provide Informed Consent to participate in the study - Ability to participate in experimental acquisitions Exclusion Criteria: * Bilateral transradial amputation * Learning disabilities * Inability to understand the informed consent form * History or evidence of any medical, neurological or psychiatric conditions, which may affect brain function, metabolism, balance or motion, perception, representing, thus, a contraindication to the study (also stump pain or tenderness), other than the medical conditions or pathologies that have caused the upper-limb amputation * Hypertension, cardiovascular disease, and other endocrine diseases, neuromuscular diseases, malignancies * Vision and/or hearing problems severe enough to interfere with experimental procedures * Carrier of infectious diseases * Alcoholism or other substance abuse
Where this trial is running
Pisa, PI
- Department of Neurorehabilitation, Univeristy Hospital of Pisa — Pisa, Pi, Italy (Recruiting)
Study contacts
- Study coordinator: Valentina Azzollini, MD
- Email: valentina.azzollini@unipi.it
- Phone: +39 050996734
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.