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

RecruitingNAAges any - 80 YearsAllIstituti Clinici Scientifici Maugeri SpA
NCT06471855 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Most of the limb amputation related to vascular disease is often secondary to a diagnosis of type 2 diabetes mellitus. The amputation involves significant motor, psychological, and social challenges for patients, with a major effect on their psycho-physical health. The psychological processes that characterize this clinical population are still poorly investigated. Adopting a biopsychosocial approach, the present randomized prospective quali-quantitative study protocol aims to evaluate the behavioural and psychological adaptation at various stages of the disease: risk of amputation, lower limb amputation, and prosthesis use. In the last phase, patients with prosthesis will receive traditional rehabilitation treatment and technology-based rehabilitation (experimental) or not (active comparator) with randomized controlled enrolment. The evaluation will be based on a semi-structured intervi

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📋 Eligibility rules (as published)
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.
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What it tests

  • Multidisciplinary Conventional and Technology-based Rehabilitation
  • Multidisciplinary Conventional Rehabilitation
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Where

1 site
Istituti Clinici Scientifici Maugeri, IRCCS
Pavia, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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