NCT06886295 Clinical Evaluation of Intuitive, Bidirectional Strategies for the Control of Multi-articulated Prostheses for Upper Limb Amputation
| NCT ID | NCT06886295 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna |
| Condition | Upper Limb Amputation |
| Study Type | INTERVENTIONAL |
| Enrollment | 14 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 14 participants in total. It began in 2025-04-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The investigators propose to validate a non-invasive upper limb prosthesis capable of combining: 1) intuitive movement control through machine learning applied to myoelectric signals, and 2) vibrotactile sensory feedback in response to touch and object release events. The prosthesis is composed at the minimum of skin-surface electrodes for myoelectric signals, vibrotactile actuators, a multi-articulated and instrumented hand prosthesis and a centralized control system. Such system is validated for several weeks in non-supervised environments.
Eligibility Criteria
Inclusion Criteria: * subjects with transradial amputation, and minimum experience in the use of myoelectric prosthesis; * subjects who have expressed informed consent to participate in the study and consent to data processing. Exclusion Criteria: * subjects with obvious visual and oculomotor defects; * concomitant comorbidities/disabilities/chronic conditions, general or localized (Multiple Sclerosis, Parkinson's disease, muscle tone disorders, malignant neoplasms, etc.), which may interfere with the performance of the study; * pregnancy or breastfeeding; * declared or evident cognitive deficits that compromise the understanding of the required tasks (mini Mental State Examination≤ 24); * difficulty in understanding the Italian language.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06886295 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Upper Limb Amputation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06886295 currently recruiting?
Yes, NCT06886295 is actively recruiting participants. Contact the research team at enzo.mastinu@santannapisa.it for enrollment information.
Where is the NCT06886295 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT06886295 clinical trial?
NCT06886295 is sponsored by Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna. The trial plans to enroll 14 participants.