NCT07861958 Acceptability of Paediatric Wrist Orthoses Through Co-design
| NCT ID | NCT07861958 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Eugenio Medea |
| Condition | Cerebral Palsy (CP) |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2026-06-18 |
| Primary Completion | 2028-04-18 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 12 participants in total. It began in 2026-06-18 with a primary completion date of 2028-04-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07861958 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 14 Years, studying Cerebral Palsy (CP). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07861958 currently recruiting?
Yes, NCT07861958 is actively recruiting participants. Contact the research team at luigi.piccinini@lanostrafamiglia.it for enrollment information.
Where is the NCT07861958 trial being conducted?
This trial is being conducted at Bosisio Parini, Italy.
Who is sponsoring the NCT07861958 clinical trial?
NCT07861958 is sponsored by IRCCS Eugenio Medea. The trial plans to enroll 12 participants.
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