Evaluation of a new prosthesis for upper limb amputation control
Clinical Evaluation of Intuitive, Bidirectional Strategies for the Control of Multi-articulated Prostheses for Upper Limb Amputation
This study is testing a new type of upper limb prosthesis that uses machine learning to help people with amputations move more naturally and feel better about using it compared to the usual control methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 14 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna Academic / other |
| Locations | 1 site (Bologna, Bo) |
| Trial ID | NCT06886295 on ClinicalTrials.gov |
What this trial studies
This study aims to validate a non-invasive upper limb prosthesis that utilizes machine learning for intuitive movement control based on myoelectric signals, combined with vibrotactile feedback for enhanced user experience. The pilot study employs a randomized crossover design to compare this innovative control strategy against the standard direct control method. Participants will use the prosthesis in their daily lives over several weeks, allowing for assessment of dexterity, motor coordination, and user satisfaction through functional tests and questionnaires.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with transradial amputation who have some experience using myoelectric prostheses.
Not a fit: Patients with significant cognitive deficits, severe comorbidities, or those who cannot understand the Italian language may not benefit from this study.
Why it matters
Potential benefit: If successful, this prosthesis could significantly improve the quality of life for individuals with upper limb amputations by providing more intuitive control and sensory feedback.
How similar studies have performed: While the approach of integrating machine learning and sensory feedback in prosthetics is innovative, similar studies have shown promise in enhancing prosthetic control and user satisfaction.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bologna, Bo
- IRCCS Istituto Ortopedico Rizzoli — Bologna, Bo, Italy (Recruiting)
Study contacts
- Study coordinator: Enzo Mastinu, MSc, BSc, PhD
- Email: enzo.mastinu@santannapisa.it
- Phone: 0039 050 883111
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.