Co-designed wrist-hand orthosis for children with neuromotor disorders
Official title: Improving the Acceptability of Wrist Orthoses Through a Co-design Process With Pediatric Patients
Run by IRCCS Eugenio Medea · NCT07861958 · Data updated 2026-11-12
In children aged 6 to 14 with neuromotor conditions after brain injury, researchers are testing a wrist-hand brace designed with input from the kids to see if it fits better and is easier to use than their current orthosis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Years to 14 Years |
| Sex | All |
| Enrollment | 12 (estimated) |
| Sponsor | IRCCS Eugenio Medea Academic / other |
| Locations | 1 site (Bosisio Parini) |
| Status | Recruiting |
| Started | June 18, 2026 |
| Main results expected | April 18, 2028 |
| Study ends | June 18, 2028 |
| Registry record updated | October 6, 2026 |
| Trial ID | NCT07861958 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 6 to 14 years who currently use a wrist-hand orthosis and have neuromotor disorders following acquired or congenital brain injury, and who can participate in interviews and co-design activities.
✕Probably not a fit
Children without adequate verbal communication or who are not currently using a wrist-hand orthosis may not benefit from the design approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot interventional study uses a pre-post design to compare a co-designed wrist-hand orthosis against a conventional device in pediatric users. The key aim is to determine whether involvement of the child in the design process improves acceptance and satisfaction, as measured by TAM-3, while maintaining or improving functional performance assessed through upper limb kinematic analysis. Participants will complete acceptance and satisfaction assessments and undergo functional evaluations while using each orthosis. The study emphasizes patient-centered design, aesthetics, and psychosocial factors to enhance device adoption in daily life. The trial is conducted at IRCCS Eugenio Medea with collaboration from Politecnico di Milano and Barbieri S.p.A., targeting children already using a wrist-hand orthosis due to neuromotor impairment from brain injury or CP.
Why it matters
Potential benefit: If successful, the co-designed orthosis could be more acceptable and better adopted by children, potentially improving daily use and functional outcomes.
How similar studies have gone: Previous work suggests co-design and user-centered design can improve acceptability of pediatric assistive devices, though each device and population vary in outcome.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 6 and 14 years * Current user of a wrist-hand orthosis for rehabilitative and/or assistive purposes * Diagnosis of neuromotor disorder following acquired or congenital brain injury (e.g., cerebral palsy) * Adequate verbal and communicative abilities to participate in interviews and co-design activities * Currently followed at IRCCS Eugenio Medea, Bosisio Parini (LC) * Written informed consent provided by parent or legal guardian Exclusion Criteria: * Age below 6 years or above 14 years * Absence of adequate verbal and communicative abilities to participate in interviews and co-design activities (e.g., non-functional or severely limited language) * Skin allergies * Behavioural or psychiatric disorders (e.g., emotional problems, anxiety, panic attacks)
Where it's running
-
Scientific Institute IRCCS E.Medea
Bosisio Parini, Italy Recruiting
Study contacts
- Study coordinator: Luigi Piccinini, MD
- Email: luigi.piccinini@lanostrafamiglia.it
- Phone: +39 031877866
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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.