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

Recruiting now · Not applicable

Conditions studied: Lower Limb Amputation, Prosthesis User

In brief

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 investigated. The audio-recorded and transcribed interviews will be analyzed using the Interpretive Description approach.

Key facts

Study ID

NCT06471855

Run by

Istituti Clinici Scientifici Maugeri SpA

People needed

70

Starts

2023-06-01

Expected to finish

2027-06-01

Last updated by the study team

2026-02-23

Who can join

Age: any, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Risk of amputation or Lower limb amputation or prothesis use for vascular disease and diabetes type 2

You may not qualify if…

• 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.

Where it is running

• Istituti Clinici Scientifici Maugeri, IRCCS — Pavia, PV, Italy (enrolling)

Full record on ClinicalTrials.gov

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