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Acceptability of Paediatric Wrist Orthoses Through Co-design

RecruitingNAAges 6 Years - 14 YearsAllIRCCS Eugenio Medea
NCT07861958 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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,

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📋 Eligibility rules (as published)
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)
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What it tests

  • Orthosis acceptability
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Where

1 site
Scientific Institute IRCCS E.Medea
Bosisio Parini, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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