Search / Trial NCT06616402

Assessing the Usability and Reliability of the Prototype Prosthesis Devices

Launched by FONDAZIONE DON CARLO GNOCCHI ONLUS · Sep 24, 2024

Trial Information

Current as of December 22, 2024

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying new prosthetic devices designed for people who have lost a leg due to injury or illness. The focus is on testing how well these innovative devices work, especially their safety and reliability. The prosthesis features smart technology that detects signals from the body and provides feedback to help users move more naturally. It includes active joints at the knee and ankle, which adjust based on the user's movements, making everyday activities easier and more efficient.

To participate in the trial, individuals must be between 18 and 80 years old and have had a leg amputation above or below the knee for at least a year. They should also be able to walk with a prosthesis and have a maximum body weight of 100 kg. However, those with certain health issues, such as severe heart or neurological conditions, or who are unable to understand the study due to cognitive impairments, cannot participate. Participants can expect to help test these new devices, which could lead to better options for future prosthetic users.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Age between 18 and 80 years;
  • Lower limb amputation at the transfemoral or transtibial level;
  • Functional medical classification: Level K3-K4 \[25\];
  • Subjects wearing a prosthesis for at least 1 year (experienced wearers);
  • Maximum body weight 100 kg.
  • Exclusion Criteria:
  • Significant medical comorbidities: Presence of severe neurological disorders, cardiovascular diseases, uncontrolled diabetes/hypertension, or severe sensory deficits.
  • Implanted cardiac devices: Individuals with implanted pacemakers or cardioverter-defibrillators.
  • Cognitive impairment: Individuals with a Mini-Mental State Examination (MMSE) score less than 24, adjusted for age and education, indicating cognitive impairment that may compromise understanding of instructions and research participation.
  • Severe depressive symptoms: Individuals with a Beck Depression Inventory-II (BDI-II) score less than 19, indicating clinically significant depression that may affect motivation and participation in the research.
  • Severe anxiety symptoms: Individuals with a State-Trait Anxiety Inventory (STAI-Y) score less than 50, indicating clinically significant anxiety that may interfere with research participation.
  • Inability or unwillingness to provide informed consent: Individuals who are unable to understand or provide informed consent to participate in the research, or who refuse to participate.

About Fondazione Don Carlo Gnocchi Onlus

Fondazione Don Carlo Gnocchi Onlus is a distinguished non-profit organization dedicated to advancing healthcare and rehabilitation services for individuals with disabilities and chronic illnesses. Established in honor of the legacy of Don Carlo Gnocchi, the foundation focuses on integrating scientific research with clinical practice, striving to enhance the quality of life for patients through innovative therapies and comprehensive care programs. With a commitment to excellence, the foundation actively engages in clinical trials and research initiatives aimed at improving treatment outcomes and fostering a deeper understanding of rehabilitation methodologies. Its collaborative approach brings together healthcare professionals, researchers, and community stakeholders to promote well-being and support patient-centric solutions.

Locations

Florence, Fi, Italy

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0