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Klinische Studie

Acceptability of Paediatric Wrist Orthoses Through Co-design

NCT: NCT07861958 · RECRUITING

NCT-IDNCT07861958
Medizinische Daten: StatusRECRUITING
Startdatum2026-06-18
Abschluss2028-06-18
SponsorIRCCS Eugenio Medea (OTHER)
First posted
Last updated

Kurzzusammenfassung

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.

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