NCT06471855 Clinical and Psychological Adjustment of Patients With LLA: a Multidisciplinary Rehabilitative Intervention Project
| NCT ID | NCT06471855 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA |
| Condition | Lower Limb Amputation |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2023-06-01 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2023-06-01 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Antonia Dr Pierobon
PRINCIPAL INVESTIGATOR
Istituti Clinici Scientifici Maugeri, IRCCS
Frequently Asked Questions
Who can join the NCT06471855 clinical trial?
This trial is open to participants of all sexes, up to 80 Years, studying Lower Limb Amputation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06471855 currently recruiting?
Yes, NCT06471855 is actively recruiting participants. Contact the research team at antonia.pierobon@icsmaugeri.it for enrollment information.
Where is the NCT06471855 trial being conducted?
This trial is being conducted at Pavia, Italy.
Who is sponsoring the NCT06471855 clinical trial?
NCT06471855 is sponsored by Istituti Clinici Scientifici Maugeri SpA. The principal investigator is Antonia Dr Pierobon at Istituti Clinici Scientifici Maugeri, IRCCS. The trial plans to enroll 70 participants.