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 October 07, 2024

Recruiting

Keywords

Description

No description provided

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