PhiCube: a portable bilateral robot to help children improve arm movement
Pediatric Upper-Limb Rehabilitation With PhiCube, a Modular Bilateral End-Effector Device.
This study will try a portable bilateral robot called PhiCube to improve upper-arm movement in children aged 4–18 with congenital or acquired neuromotor disorders and in a small group with developmental coordination disorder.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 4 Years to 18 Years |
| Sex | All |
| Sponsor | Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato Academic / other |
| Locations | 6 sites (Bosisio Parini, LC and 5 other locations) |
| Trial ID | NCT07092436 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, within-group pilot study testing a modular, portable bilateral end-effector device (PhiCube) for pediatric upper-limb rehabilitation. Children aged 4–18 with congenital or acquired neuromotor disorders—and a smaller cohort with developmental coordination disorder (DCD)—will receive robotic bilateral upper-limb training. Standardized assessments, including the Melbourne Assessment-2 (MA2) as the primary outcome, will be administered before and after the intervention to measure changes in movement quality. The study focuses on feasibility, usability, and potential effects on movement planning as well as functional arm performance.
Who should consider this trial
Good fit: Ideal candidates are children aged 4–18 with a diagnosis of congenital or acquired neuromotor disorder (MAS <3, MACS I–IV) or with DCD, who can understand the activities and are able to attend the participating centers.
Not a fit: Children with severe sensory deficits, new medical conditions that prevent participation, rapidly worsening comorbidities, or inability to attend sessions are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, PhiCube could improve upper-limb movement quality and planning in children, potentially increasing their functional use of the affected arm and daily independence.
How similar studies have performed: Bilateral robotic and other robot-assisted upper-limb approaches have shown promising results in pediatric and adult neurorehabilitation, but PhiCube as a portable modular device is novel and currently supported only by pilot-level evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * For subjects with congenital and acquired neuromotor disorders: * Diagnosis of congenital and acquired neuromotor disorders * Age between 4 and 18 years at the time of recruitment * Modified Ashworth Scale (MAS) less than 3 * MACS level I-IV * Sufficient capacity to understand the proposed activities * Availability to attend the facility * For subjects with developmental coordination disorder (DCD): * Diagnosis of developmental coordination disorder (DCD) * Age between 4 and 18 years at the time of recruitment * Sufficient capacity to understand the proposed activities * Availability to attend the facility Exclusion Criteria: * For subjects with congenital and acquired neuromotor disorders: * Severe sensory deficits * Onset of pathologies that prevent participation * Worsening of pre-existing comorbidities * For subjects with developmental coordination disorder (DCD): * Severe sensory deficits * Onset of pathologies that prevent participation * Worsening of pre-existing comorbidities
Where this trial is running
Bosisio Parini, LC and 5 other locations
- IRCCS Eugenio Medea — Bosisio Parini, Lc, Italy (Recruiting)
- IRCCS Fondazione Stella Maris — Calambrone, Pi, Italy (Recruiting)
- Fondazione Don Gnocchi - Centro S. Maria al Mare — Salerno, Sa, Italy (Recruiting)
- IRCCS Istituto Giannina Gaslini — Genova, Italy (Recruiting)
- Fondazione Don Gnocchi IRCCS - Centro Santa Maria Nascente — Milan, Italy (Recruiting)
- IRCCS Fondazione Mondino — Pavia, Italy (Recruiting)
Study contacts
- Study coordinator: Matteo Malosio, PhD
- Email: matteo.malosio@cnr.it
- Phone: +39.0341.235.0203
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.