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Acceptability of Paediatric Wrist Orthoses Through Co-design

Sponsor: IRCCS Eugenio Medea • ClinicalTrials.gov ID: NCT07861958

Registry updated: 2026-10-06

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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. 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.

Interventions

Orthosis acceptability (Device)
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.

Eligibility 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)

Conditions

Cerebral Palsy (CP) Brain Injuries Neuromotor Dysfunction

Locations

Scientific Institute IRCCS E.Medea — Bosisio Parini, Italy

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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