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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.

NCT06666829 · IRCCS Fondazione Stella Maris · Updated 7 May 2025

What is being tested
Multidomain intervention; Single domain intervention
For
Neuromotor Impairments
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 5 years to 21 years. About 194 people. The full rules are on the registry page.
Where
Italy (6 sites)
When
Starts or started 4 Nov 2024, ends 31 Jan 2027. Registered 31 Oct 2024.
Results
None posted yet.

In the researchers' words

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
ClinicalTrials.gov, NCT06666829

Sites

  • IRCCS Giannina GasliniGenova, Genova, Italy
  • IRCCS Eugenio MedeaBosisio Parini, Lecco, Italy
  • Fondazione Don Gnocchi IRCCS centro "Santa Maria Nascente"Milan, Milano, Italy
  • IRCCS Istituto Neurologico Naz.le C.MondinoPavia, Pavia, Italy
  • IRCCS Fondazione Stella MarisCalambrone, Pisa, Italy
  • Fondazione Don Gnocchi IRCCS centro "S.Maria al Mare"Salerno, Salerno, Italy