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.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-21
SponsorIRCCS Fondazione Stella Maris

About this trial

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

Eligibility criteria

Qualifiers

Confirmed diagnosis of developmental disorder and/or disability, either congenital or acquired;

Age between 5 and 21 years at the time of recruitment;

Verbal and/or non-verbal reasoning abilities > 70 or > 5th percentile, as assessed by standardized tests such as Colored Progressive Matrices (CPM), WISC-IV or WISC-V, WPPSI-III or WPPSI-IV, Leiter-3, Griffiths III.

Disqualifiers

Presence of severe comorbidities and/or behavioral/cognitive disorders that prevent adequate patient compliance with both conventional and robotic rehabilitation treatment (severe intellectual disability);

Uncontrolled epilepsy;

Presence of severe sensory deficits;

Patients who have undergone orthopedic functional surgery or rhizotomy and/or botulinum toxin treatment in the last 6 months;

Trial design

Treatments tested in this trial

  • Multidomain intervention
  • Single domain intervention

Treatment groups

194 Participants
are divided into 2 treatment groups

Sponsors and collaborators

IRCCS Fondazione Stella Maris

Lead sponsor

IRCCS Eugenio Medea

Collaborator

Fondazione Don Carlo Gnocchi Onlus

Collaborator

IRCCS National Neurological Institute "C. Mondino" Foundation

Collaborator

Istituto Giannina Gaslini

Collaborator