Evaluation of a new prosthesis for upper limb amputation control

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• People with upper-limb amputation try the TASKA GEN2 multi-grip bionic hand and compare it with other popular prostheses

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  Recruiting TASKA Prosthetics · Multiple Locations · NCT07876115

• Optimize how you control a powered upper-limb prosthesis

  This study tests new electrode configurations to improve myoelectric control for people with a below-elbow amputation using a prosthetic arm.

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• Microneurography and Intraneural Microstimulation for Upper Limb Sensory Investigation

  This study tests how the median nerve encodes touch and whether artificial sensory information can be restored in healthy people and people with upper-limb amputations.

  Recruiting Azienda Ospedaliero, Universitaria Pisana · Pisa, Pisa · NCT07691957

• Relationship between how much of the arm is missing and balance, neck/back pain, daily activities, and reaction time in people with a unilateral upper limb amputation

  This study will see if the amount of arm loss relates to balance, neck and back pain, daily tasks, hand dexterity, and reaction time in adults who use a myoelectric or bionic prosthesis.

  Recruiting Hacettepe University · Ankara · NCT07677969

• One-handed video game controller adapter for children with limb differences

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  Recruiting University of Manitoba · Winnipeg, Manitoba · NCT05981664

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.