Actively Recruiting
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
Eligibility Criteria
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
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
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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
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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