Clinical and Psychological Adjustment of Patients With LLA: a Multidisciplinary Rehabilitative Intervention Project

Launched by ISTITUTI CLINICI SCIENTIFICI MAUGERI SPA · Jun 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how patients who have had a lower limb amputation—often due to complications from type 2 diabetes—adjust both physically and emotionally. The researchers want to understand how people cope with the challenges of amputation and using a prosthesis, looking at different stages from the risk of amputation to rehabilitation. Participants will be randomly assigned to receive either standard rehabilitation or a new technology-based rehabilitation program, which aims to help them adjust better to their new circumstances.

To be eligible for the study, participants must be at risk of amputation, have had a lower limb amputation, or currently use a prosthesis due to vascular disease related to diabetes. However, people over 80 years old, those with severe health issues or cognitive impairments, and those who cannot provide consent will not be included. Throughout the trial, participants will share their experiences through interviews, helping researchers gather important information about their physical abilities, emotional well-being, and overall quality of life. This study hopes to improve rehabilitation approaches and support for patients facing these life-changing situations.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Risk of amputation or Lower limb amputation or prothesis use for vascular disease and diabetes type 2
• Exclusion Criteria:
• • more than 80 years older
• • severe clinical condition (ie, chronic heart failure \[New York Heart Association Classification-IV - NYHA-IV\], ischemic heart disease \[Canadian Cardiovascular Society Classification-IV - CCS-IV\], neoplastic disease, acute respiratory disease);
• • non-Italian education
• • severe visual-perceptive deficits
• • severe cognitive impairment (MMSE ≤ 26 Foderaro et al, 2022);
• • severe mental health condition or psychiatric disorder compromising participation in the study;
• • absence or withdrawal of the informed consent to participate.