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Acceptability of Paediatric Wrist Orthoses Through Co-design

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT07861958
Lead Sponsor IRCCS Eugenio Medea
Collaborators: Politecnico di Milano, Barbieri S.p.A. - Progettiamo Autonomia
Conditions
(from sponsor)
Cerebral Palsy (CP), Brain Injuries, Neuromotor Dysfunction
Related terms Brain Injuries, Cerebral Palsy, Patient Satisfaction
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov