New rehabilitation solutions for children with neuromotor impairments using technology and robotics
Innovative Paths to Paediatric Care: A Multicenter Study on the Efficacy of Multi-Domain Technological and Robotic Rehabilitation.
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 194 (estimated) |
| Ages | 5 Years to 21 Years |
| Sex | All |
| Sponsor | IRCCS Fondazione Stella Maris Academic / other |
| Locations | 6 sites (Genova, Genova and 5 other locations) |
| Trial ID | NCT06666829 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 5 to 21 with confirmed developmental disorders or disabilities and adequate reasoning abilities.
Not a fit: Patients with severe comorbidities, uncontrolled epilepsy, or significant cognitive impairments may not benefit from this study.
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 performed: Previous studies have shown promise in using robotic and technological interventions for rehabilitation, suggesting potential success for this multidomain approach.
Eligibility criteria
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 this trial is running
Genova, Genova and 5 other locations
- IRCCS Giannina Gaslini — Genova, Genova, Italy (Not_yet_recruiting)
- IRCCS Eugenio Medea — Bosisio Parini, Lecco, Italy (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.