Controlling robotic hand prostheses and restoring sensory feedback for amputees
Development of Innovative Strategies for the Control of Robotic Hand Prostheses Based on High-density Electromyography and Restitution of Sensory Feedback Via Trans-cutaneous Electrical Stimulation
This study is testing a new way for upper limb amputees to control robotic hand prostheses and feel sensations like touch and temperature using special technology.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro Academic / other |
| Locations | 1 site (Budrio, BO) |
| Trial ID | NCT06486571 on ClinicalTrials.gov |
What this trial studies
This study focuses on developing advanced prosthetic systems for upper limb amputees by utilizing high-density surface electromyography (HD-sEMG) to control robotic hand prostheses. It aims to enhance the functionality of prosthetics by restoring sensory feedback through Transcutaneous Electrical Nerve Stimulation (TENS), allowing users to perceive sensations such as touch and temperature. The approach seeks to create bidirectional communication between the prosthesis and the user, improving overall usability and experience. Participants will undergo electromyography recording and TENS treatment to evaluate the effectiveness of these techniques.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 18 to 65 with stable upper limb amputations and intact skin integrity.
Not a fit: Patients with clinical instability, pregnancy, or implanted devices that may interfere with TENS stimulation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the quality of life for upper limb amputees by providing them with enhanced control and sensory feedback from their prosthetic devices.
How similar studies have performed: While the approach of combining HD-sEMG and TENS for prosthetic control and sensory feedback is innovative, similar studies have shown promise in enhancing prosthetic functionality and user experience.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Upper limb amputation; * Stable clinical condition; * Skin integrity of the stump; * Age between 18 and 65 years; * High level of motivation to participate in the study and acceptance of the purpose of the study; * Signed informed consent document. Exclusion Criteria: * Clinical instability; * Dehiscence of the amputation wound; * Failure to complete the informed consent; * State of pregnancy; * Implanted devices that can interfere with TENS stimulation (e.g. pacemakers);
Where this trial is running
Budrio, BO
- Centro Protesi Inail — Budrio, Bo, Italy (Recruiting)
Study contacts
- Study coordinator: Emanuele Gruppioni, PhD
- Email: e.gruppioni@inail.it
- Phone: +390516936609
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.