Acceptability of Paediatric Wrist Orthoses Through Co-design

Condition(s) studied

Investigational drug(s) / intervention(s)

Orthosis acceptability: Participants will receive a personalized wrist-hand orthosis developed through a co-design process. During two structured workshops, children and caregivers express aesthetic preferences and personalization needs using creative tools (drawings, collage, 3D-printed prototypes). Upper limb anatomy is acquired via 3D scanning and/or anthropometric measurements. The orthosis is then digitally designed, 3D-printed with biocompatible materials using a multicolor FDM printer, finished manually, and certified as a custom medical device per MDR 745/2017. Participants evaluate the co-designed orthosis in terms of acceptability (TAM-3), satisfaction (QUEST 2.1), and upper limb functional performance (optoelectronic motion analysis), comparing outcomes with their conventional orthosis assessed at baseline.

Study 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

Primary outcome measure(s)

• Change in wrist-hand orthosis acceptability as measured by the Technological Acceptance Measure (TAM-3) score between first and last study visit — Baseline and up to 12 months
  Orthosis acceptability is measured using the TAM-3, adapted for the pediatric population, evaluating 9 constructs across 27 items: perceived usefulness, perceived ease of use, self-efficacy, perception of external control, playfulness, anxiety, enjoyment, output quality, and behavioural intention. Each construct is scored as the mean of its items on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree); higher scores indicate greater acceptability, except for the anxiety subscale where lower scores indicate better outcome. The questionnaire is administered separately to the child and caregiver at baseline (conventional orthosis) and at the final visit (co-designed orthosis). Change from baseline is calculated as the difference between final and baseline scores for each subscale.

Trial sites (1)

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