RecruitingNot ApplicableNCT06471855

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

Clinical and Psychological Adjustment of Patients With Lower Limb Amputation: a Multidisciplinary Rehabilitative Intervention Project (AMP_ADinRehab Study)

Sponsor

Istituti Clinici Scientifici Maugeri SpA

Enrollment

70 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

Lower limb amputation Prosthesis User

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

Max Age: 80 Years

Inclusion Criteria1

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

Exclusion Criteria7

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.

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Interventions

DEVICEMultidisciplinary Conventional and Technology-based Rehabilitation

Patients will receive conventional treatment consisting of two daily sessions (3 weeks) and including traditional rehabilitation activities like range of motion exercises (passive, active assisted, and active), progressive resistive exercises, balance and strength training, and aerobic conditioning. The intervention procedures will follow the routine multidisciplinary clinical practice of the Institute where the study will be carried out. According to their individualized rehabilitation project, patients will undergo non-immersive VR-based rehabilitation. VR-based rehabilitation will consist of one daily session (3 weeks) and will be conducted by the implementation of a single non-immersive VR device among the D-WallTM (TechnoBody SRL, Italy). Part of the duration of the whole treatment will be dedicated to the use of the device, resulting in the same amount of rehabilitation for all participants.

OTHERMultidisciplinary Conventional Rehabilitation

Patients will receive conventional treatment consisting of two daily sessions (3 weeks) and including traditional rehabilitation activities like range of motion exercises (passive, active assisted, and active), progressive resistive exercises, balance and strength training, and aerobic conditioning. The intervention procedures will follow the routine multidisciplinary clinical practice of the Institute where the study will be carried out. Procedures will be adapted according to the patient's medical diagnosis, disability severity, and to consequent rehabilitation objectives in favor of an individualized rehabilitation project and program. If necessary, patients might therefore undergo parallel rehabilitation activities (ie, occupational therapy, cognitive stimulation) that will be kept under control throughout data collection and analyses.