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

Study acronym: AMPADinRehab
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Primary completion date: Jan 2026 to Jan 2027
    • Study completion date: Jun 2026 to Jun 2027
    v4
  2. Notable Primary completion date: Jun 30, 2025 to Jan 2026
    • Study completion date: Jun 30, 2026 to Jun 2026
    • Start date: Jul 1, 2023 to Jun 1, 2023
    v3
  3. Notable Primary completion date: Dec 31, 2024 to Jun 30, 2025
    • Start date: Jun 1, 2023 to Jul 1, 2023
    • Primary endpoints revised (15)
    • Study completion date: Jun 30, 2025 to Jun 30, 2026
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06471855
Lead Sponsor Istituti Clinici Scientifici Maugeri SpA
Conditions
(from sponsor)
Lower Limb Amputation, Prosthesis User
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov