Actively Recruiting

Phase Not Applicable
Age: 0 - 80Years
All Genders
ID06471855

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

Led by Istituti Clinici Scientifici Maugeri SpA · Updated on 2026-02-23

70

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to explore how patients with lower limb amputation (LLA), often caused by vascular disease and type 2 diabetes, adapt both psychologically and behaviorally at different stages of their condition. The study focuses on understanding the emotional impact, quality of life, anxiety, depression, and acceptance related to amputation and prosthesis use using interviews and rating scales. It emphasizes a holistic view of patient adjustment and the factors influencing adaptation to prosthesis and rehabilitation. Participants will receive either traditional rehabilitation alone or traditional rehabilitation combined with technology-based rehabilitation using a non-immersive virtual reality device called D-WallTM. Both groups will undergo two daily conventional therapy sessions over three weeks, including exercises for range of motion, strength, balance, and aerobic conditioning. The experimental group will have an additional daily session involving the VR device, aiming to enhance the rehabilitation experience. Throughout the study, patients' medical history, motor function, autonomy, fall risk, pain, and psychological health will be assessed. Researchers will use multiple tools such as the Modified Barthel Index, Functional Independence Measure, anxiety and depression questionnaires, body image scales, and prosthesis experience assessments. The study will analyze changes from baseline to three weeks of rehabilitation and includes audio-recorded interviews to gain qualitative insights. The total participation time covers the rehabilitation period and assessment points.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 0 - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Risk of amputation or lower limb amputation or prosthesis use due to vascular disease and type 2 diabetes
Not Eligible

You will not qualify if you...

  • Age over 80 years
  • Severe clinical conditions such as chronic heart failure (NYHA-IV), ischemic heart disease (CCS-IV), neoplastic disease, or acute respiratory disease
  • Non-Italian education
  • Severe visual or perceptive deficits
  • Severe cognitive impairment (MMSE 64 26)
  • Severe mental health condition or psychiatric disorder that affects study participation
  • Absence or withdrawal of informed consent to participate

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 3 weeks

Participants undergo a multidisciplinary rehabilitative intervention. This includes conventional rehabilitation with traditional activities such as range of motion exercises, strength training, and aerobic conditioning. Depending on group assignment, participants either receive additional non-immersive virtual reality-based rehabilitation or conventional rehabilitation exclusively.

Daily sessions for 3 weeks

Trial Site Locations

Total: 1 location

1

Istituti Clinici Scientifici Maugeri, IRCCS

Pavia, PV, Italy, 27100

Actively Recruiting

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Research Team

A

Antonia Dr Pierobon

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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