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
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