Actively Recruiting

Phase Not Applicable
Age: 5Years - 21Years
All Genders
NCT06666829

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.

Led by IRCCS Fondazione Stella Maris · Updated on 2025-05-07

194

Participants Needed

6

Research Sites

116 weeks

Total Duration

On this page

Sponsors

I

IRCCS Fondazione Stella Maris

Lead Sponsor

I

IRCCS Eugenio Medea

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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.

Who Can Participate

Age: 5Years - 21Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 greater than 70 or above the 5th percentile, assessed by standardized tests such as Colored Progressive Matrices, WISC-IV or WISC-V, WPPSI-III or WPPSI-IV, Leiter-3, or Griffiths III
Not Eligible

You will not qualify if you...

  • Severe comorbidities and/or behavioral/cognitive disorders preventing compliance with rehabilitation (e.g., severe intellectual disability)
  • Uncontrolled epilepsy
  • Severe sensory deficits
  • Orthopedic functional surgery, rhizotomy, or botulinum toxin treatment within the last 6 months
  • Involvement of the peripheral nervous system

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

IRCCS Giannina Gaslini

Genova, Genova, Italy, 16147

Not Yet Recruiting

2

IRCCS Eugenio Medea

Bosisio Parini, Lecco, Italy, 23842

Actively Recruiting

3

Fondazione Don Gnocchi IRCCS centro "Santa Maria Nascente"

Milan, Milano, Italy, 20148

Not Yet Recruiting

4

IRCCS Istituto Neurologico Naz.le C.Mondino

Pavia, Pavia, Italy, 27100

Not Yet Recruiting

5

IRCCS Fondazione Stella Maris

Calambrone, Pisa, Italy, 56128

Not Yet Recruiting

6

Fondazione Don Gnocchi IRCCS centro "S.Maria al Mare"

Salerno, Salerno, Italy, 84131

Not Yet Recruiting

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Research Team

G

Giuseppina Sgandurra Prof.ssa Sgndurra

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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