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

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Maximum Age: 80
Healthy Volunteers: f
View:

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

Locations
Other Locations
Italy
Istituti Clinici Scientifici Maugeri, IRCCS
RECRUITING
Pavia
Contact Information
Primary
Antonia Dr Pierobon
antonia.pierobon@icsmaugeri.it
+390385247255
Time Frame
Start Date: 2023-07-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 70
Treatments
Experimental: Technology-based Rehabilitation Group
Patients will undergo conventional treatment and, additionally, virtual reality-based rehabilitation.
Active_comparator: Conventional Rehabilitation Group
Patients will undergo conventional treatment exclusively.
Related Therapeutic Areas
Sponsors
Leads: Istituti Clinici Scientifici Maugeri SpA

This content was sourced from clinicaltrials.gov