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Acceptability of Paediatric Wrist Orthoses Through Co-design
Sponsor: IRCCS Eugenio Medea
Summary
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.
Official title: Improving the Acceptability of Wrist Orthoses Through a Co-design Process With Pediatric Patients
Key Details
Gender
All
Age Range
6 Years - 14 Years
Study Type
INTERVENTIONAL
Enrollment
12
Start Date
2026-06-18
Completion Date
2028-06-18
Last Updated
2026-10-06
Healthy Volunteers
No
Interventions
Orthosis acceptability
Participants will receive a personalized wrist-hand orthosis developed through a co-design process. During two structured workshops, children and caregivers express aesthetic preferences and personalization needs using creative tools (drawings, collage, 3D-printed prototypes). Upper limb anatomy is acquired via 3D scanning and/or anthropometric measurements. The orthosis is then digitally designed, 3D-printed with biocompatible materials using a multicolor FDM printer, finished manually, and certified as a custom medical device per MDR 745/2017. Participants evaluate the co-designed orthosis in terms of acceptability (TAM-3), satisfaction (QUEST 2.1), and upper limb functional performance (optoelectronic motion analysis), comparing outcomes with their conventional orthosis assessed at baseline.
Locations (1)
Scientific Institute IRCCS E.Medea
Bosisio Parini, Italy