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

NARecruitingINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

July 1, 2023

Primary Completion Date

June 30, 2025

Study Completion Date

June 30, 2026

Conditions
Lower Limb AmputationProsthesis User
Interventions
DEVICE

Multidisciplinary 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.

OTHER

Multidisciplinary 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.

Trial Locations (1)

27100

RECRUITING

Istituti Clinici Scientifici Maugeri, IRCCS, Pavia

All Listed Sponsors
lead

Istituti Clinici Scientifici Maugeri SpA

OTHER