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.
Age range
80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Short-term changes in Modified Barthel Index (MBI)
Timeframe: From baseline (T0) to 3 weeks of rehabilitation (T1)
Short-term changes in Morse Fall Scale (MFS)
Timeframe: From baseline (T0) to 3 weeks of rehabilitation (T1)
Short-term changes in Functional Independence Measure (FIM)
Timeframe: From baseline (T0) to 3 weeks of rehabilitation (T1)
Short-term changes in Timed Up & Go Test (TUG)
Timeframe: From baseline (T0) to 3 weeks of rehabilitation (T1)
Short-term changes in Visual Analogue Scale (VAS)
Timeframe: From baseline (T0) to 3 weeks of rehabilitation (T1)
Amputee Mobility Predictor (AMP)
Timeframe: 3 weeks of rehabilitation (T1)
The Mini Mental State Examination (MMSE)
Timeframe: Baseline (T0)
The Personality Inventory for the DSM-5 - Short Version (PID-5-BF)
Timeframe: Baseline (T0)
The Antecedents and Self-Efficacy on Adherence Schedule (ASonA)
Timeframe: Baseline (T0)
Short-term changes in EuroQoL-VAS (EQ-VAS)
Timeframe: From baseline (T0) to 3 weeks of rehabilitation (T1)
Short-term changes in Generalized Anxiety Disorder-7 (GAD-7)
Timeframe: From baseline (T0) to 3 weeks of rehabilitation (T1)
Short-term changes in Patient Health Questionnaire-9 (PHQ-9)
Timeframe: From baseline (T0) to 3 weeks of rehabilitation (T1)
Short-term changes in Body Image Scale (BIS)
Timeframe: From baseline (T0) to 3 weeks of rehabilitation (T1)
The Trinity Amputation and Prosthesis Experience Scales (TAPES)
Timeframe: 3 weeks of rehabilitation (T1)
The Technology Assisted Rehabilitation Patient Perception Questionnaire (TARPP-Q)
Timeframe: 3 weeks of rehabilitation (T1)