Multicenter Study That Offers New Solutions for Paediatric Rehabilitation by Proposing a Rehabilitation Plan Based on Each Child's Needs Using New Technological and Robotic Devices, Combined Among Them.

Summary

The goal of this clinical trial is to demonstrate the efficacy of multi domain robotic and technological rehabilitation on everyday life and satisfaction in children with neuromotor conditions. The main questions it aims to answer are:

* Will we have significant changes using the COPM in children taking part in the sperimental group?
* The children who will undergo the multidomain treatment will also experience functional improvements in individual areas?
* Thy type of treatment will improve motivation, active participation and satisfaction in children?

Researcher will compare the multidomain treatment to standard care proposed by the included clinical centers: single domain rehabilitation with one innovative device. Both groups will undergo also conventional multidomain therapy.

This will be done to see if using a holistic approach, and including every need of the child in the rehabilitation plan, can lead to greater improvements in quality of life compared to the control group.

Participant will:

* Be evaluated 3 times with clinical outcome measures
* Take part in a rehabilitation program, at least 20 x 2hours sessions treatment, organized in:

* 4 weeks, 5 times per week
* 7 weeks, 3 times per week

Conditions

• Neuromotor Impairments

Interventions

OTHER

Multidomain intervention

treatment plan using combination of more than one technological or robotic devices, choosing from: Virtual Reality Rehabilitation System (VRSS), Khymeia TR; HomeKIT Khymeia; VRSS Khymeia EVO; Myro® Tyromotion; Diego Tyromotion; Tyrostation Tyromotion; Pablo® Tyromotion; Amadeo Tyromotion; Lexo® Tyromotion; Humaware MObile RoboT for upper Limb NeurOortho Rehabilitation (MOTORE); Humanware Upper Limb TRAcker(ULTRA+); Gloreha Sinfonia plus; C-Mill Motek; Gait Real Time Analysis Laboratory (GRAIL) Motek Medical; Nirvana BTS; Agilik; Armeo Spring pediatrico Hocoma; Lokomat ® Hocoma; Hand Tutor, Leg Tutor, Arm Tutor (MediTouch); Care Lab; Dessintey IVS3; Rehacom Hasomed; Hunova; GEO System (Kineo). In this way, the child will be taken care of holistically, considering their needs from a motor, cognitive, and speech therapy perspective. The treatment plan will also include a conventional multi-level rehabilitation program.

DEVICE

Single domain intervention

Treatment plan using only one of these technological or robotic device: Virtual Reality Rehabilitation System (VRSS), Khymeia TR; HomeKIT Khymeia; VRSS Khymeia EVO; Myro® Tyromotion; Diego Tyromotion; Tyrostation Tyromotion; Pablo® Tyromotion; Amadeo Tyromotion; Lexo® Tyromotion; Humaware MObile RoboT for upper Limb NeurOortho Rehabilitation (MOTORE); Humanware Upper Limb TRAcker(ULTRA+); Gloreha Sinfonia plus; C-Mill Motek; Gait Real Time Analysis Laboratory (GRAIL) Motek Medical; Nirvana BTS; Agilik; Armeo Spring pediatrico Hocoma; Lokomat ® Hocoma; Hand Tutor, Leg Tutor, Arm Tutor (MediTouch); Care Lab; Dessintey IVS3; Rehacom Hasomed; Hunova; GEO System (Kineo). Technological rehabilitation will focus on the main specific need for the child, it'll be chosen individually. The treatment plan will also include a conventional multi-level rehabilitation program.

Sponsors & Collaborators

• IRCCS Eugenio Medea

  collaborator OTHER

• Fondazione Don Carlo Gnocchi Onlus

  collaborator OTHER

• Fondazione Mondino

  collaborator OTHER

• Istituto Giannina Gaslini

  collaborator OTHER

• IRCCS Fondazione Stella Maris

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

5 Years

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-11-04

Primary Completion

2026-07-31

Completion

2027-01-31

Countries

• Italy

Study Locations