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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.

RecruitingNAAges 5 Years - 21 YearsAllIRCCS Fondazione Stella Maris
NCT06666829 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 rehabi

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * 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; * Involvement of the peripheral nervous system
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What it tests

  • Multidomain intervention
  • Single domain intervention
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Where

6 sites
IRCCS Giannina Gaslini
Genova, Italy
IRCCS Eugenio Medea
Bosisio Parini, Italy
Fondazione Don Gnocchi IRCCS centro "Santa Maria Nascente"
Milan, Italy
IRCCS Istituto Neurologico Naz.le C.Mondino
Pavia, Italy
IRCCS Fondazione Stella Maris
Calambrone, Italy
Fondazione Don Gnocchi IRCCS centro "S.Maria al Mare"
Salerno, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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