New rehabilitation solutions for children with neuromotor impairments using technology and robotics
Official title: Innovative Paths to Paediatric Care: A Multicenter Study on the Efficacy of Multi-Domain Technological and Robotic Rehabilitation.
Run by IRCCS Fondazione Stella Maris · NCT06666829 · Data updated 2026-11-12
This study is testing a new rehabilitation approach using technology and robotics to see if it helps children with neuromotor impairments do better in everyday life compared to standard care.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 5 Years to 21 Years |
| Sex | All |
| Enrollment | 194 (estimated) |
| Sponsor | IRCCS Fondazione Stella Maris Academic / other |
| Locations | 6 sites (Genova, Genova and 5 other locations) |
| Status | Recruiting |
| Started | November 4, 2024 |
| Main results expected | July 31, 2026 |
| Study ends | January 31, 2027 |
| Registry record updated | May 7, 2025 |
| Trial ID | NCT06666829 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 5 to 21 with confirmed developmental disorders or disabilities and adequate reasoning abilities.
✕Probably not a fit
Patients with severe comorbidities, uncontrolled epilepsy, or significant cognitive impairments may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the effectiveness of a multidomain rehabilitation approach that incorporates robotic and technological devices tailored to the individual needs of children with neuromotor impairments. Participants will be divided into two groups: one receiving the multidomain treatment and the other receiving standard care with a single innovative device. The study will assess changes in everyday life and satisfaction using the Canadian Occupational Performance Measure (COPM) and will monitor functional improvements and motivation levels. A total of 194 patients will be recruited, with data collected and pseudonymized to ensure privacy and adherence to treatment protocols.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the quality of life and rehabilitation outcomes for children with neuromotor conditions.
How similar studies have gone: Previous studies have shown promise in using robotic and technological interventions for rehabilitation, suggesting potential success for this multidomain approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
IRCCS Eugenio Medea
Bosisio Parini, Lecco, Italy Recruiting -
IRCCS Giannina Gaslini
Genova, Genova, Italy Not yet recruiting -
Fondazione Don Gnocchi IRCCS centro "Santa Maria Nascente"
Milan, Milano, Italy Not yet recruiting -
IRCCS Istituto Neurologico Naz.le C.Mondino
Pavia, Pavia, Italy Not yet recruiting -
IRCCS Fondazione Stella Maris
Calambrone, Pisa, Italy Not yet recruiting -
Fondazione Don Gnocchi IRCCS centro "S.Maria al Mare"
Salerno, Salerno, Italy Not yet recruiting
Study contacts
- Study coordinator: Giuseppina Sgandurra Prof.ssa Sgndurra
- Email: giuseppina.sgandurra@fsm.unipi.it
- Phone: 050886284
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
AI-based model checks how engaged a child is during rehab and how well they move
A small pilot study tests an artificial intelligence tool that helps therapists see in real time how engaged a child is and how they move during therapy using Lokomat or GRAIL.
-
Structured robotic gait training with the Trexo walker
This study will test whether a structured Trexo robotic gait training program helps people with neuromotor walking impairments (for example children with cerebral palsy or those with traumatic brain injury) improve walking and reach their therapy goals.
-
Physical therapy using horses for children with neuromotor impairments
This study is testing if physical therapy that uses horses can help children aged 6-17 with neuromotor disorders improve their motor skills better than regular play-based therapy.
-
Intensive therapy for children with neuromotor impairments
This study tests whether a special therapy can help children with movement difficulties improve their motor skills by focusing more on their weaker side.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.