Acceptability of Paediatric Wrist Orthoses Through Co-design
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Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 14 years old?
Source: NCT07861958, who can take part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- IRCCS Eugenio Medea
- Trial code
- NCT07861958
- Record updated
- 6 October 2026
- Original description
The goal of this pilot interventional study (pre-post design) is to learn if a co-designed wrist-hand orthosis can improve acceptability compared to a conventional orthosis in children aged 6 to 14 years with neuromotor disorders following acquired or congenital brain injury.Read full original descriptionShow less
Improving the Acceptability of Wrist Orthoses Through a Co-design Process With Pediatric Patients
The goal of this pilot interventional study (pre-post design) is to learn if a co-designed wrist-hand orthosis can improve acceptability compared to a conventional orthosis in children aged 6 to 14 years with neuromotor disorders following acquired or congenital brain injury.
The main questions it aims to answer are:
Does a wrist-hand orthosis developed through a co-design process with the pediatric patient show greater acceptability - measured via the Technological Acceptance Measure (TAM-3) - compared to the conventional orthosis already used by the patient? Does the co-designed orthosis guarantee at least equivalent functional performance to the conventional orthosis, as assessed through upper limb kinematic analysis?
Researchers will compare the co-designed orthosis to the conventional orthosis to see if the co-design and personalization process improves acceptance, satisfaction, and functional outcomes.
Participants will:
Complete acceptance and satisfaction questionnaires (TAM-3 and QUEST 2.1) and undergo functional upper limb assessment while wearing their conventional orthosis Participate in two structured co-design workshops (~1.5 hours each) involving creative and expressive activities to define preferences for their personalized orthosis Receive and wear the co-designed 3D-printed orthosis, then repeat functional assessments and questionnaires, and take part in a semi-structured interview about their co-design experience.
Inclusion: 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: Skin allergies; Behavioural or psychiatric disorders (e.g., emotional problems, anxiety, panic attacks); 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).