Acceptability of Paediatric Wrist Orthoses Through Co-design
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- 6 és 14 év között vagy?
Forrás: NCT07861958: ki vehet részt
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Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- IRCCS Eugenio Medea
- Azonosító
- NCT07861958
- A regiszteradat frissítve
- 2026. október 6.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
Improving the Acceptability of Wrist Orthoses Through a Co-design Process With Pediatric Patients
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.
Bevonási feltételek: 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.
Kizáró feltételek: Skin allergies; Behavioural or psychiatric disorders (e.g., emotional problems, anxiety, panic attacks); 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).