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

NCT06471855 · Istituti Clinici Scientifici Maugeri SpA · Updated 23 Feb 2026

What is being tested
Multidisciplinary Conventional and Technology-based Rehabilitation; Multidisciplinary Conventional Rehabilitation
For
Lower Limb Amputation; Prosthesis User
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages Up to 80 years. About 70 people. The full rules are on the registry page.
Where
Italy
When
Starts or started 1 June 2023, ends June 2027. Registered 24 June 2024.
Results
None posted yet.

In the researchers' words

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 interview, specific to the disease stage and constructed using the Three Factor Model, and rating scales. Patient's medical history, functional status (ie, motor functionality, autonomy in BIM and FIM, risk of falls, subjective perceived pain), and psychological aspects (ie, emotional impact, HRQoL, anxiety and depression symptoms, personality traits, acceptance, adherence, body image, the experience of the prosthesis and technology-based rehabilitation, expectations for the future) will be…
ClinicalTrials.gov, NCT06471855

Sites

  • Istituti Clinici Scientifici Maugeri, IRCCSPavia, PV, Italy