Acceptability of Paediatric Wrist Orthoses Through Co-design
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-14
SponsorIRCCS Eugenio Medea
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Orthosis acceptability
DeviceParticipants 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.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: Orthosis acceptabilityExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in wrist-hand orthosis acceptability as measured by the Technological Acceptance Measure (TAM-3) score between first and last study visit
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.
Time frame
Baseline and up to 12 monthsSecondary outcomes
1
Change in upper limb functional performance as measured by optoelectronic motion analysis between first and last study visit
Upper limb kinematics are assessed using a certified optoelectronic motion analysis system (BTS Bioengineering Smart DX). Participants perform standardized functional movements (Hand-to-Mouth and Hit-to-Target). Active Range of Motion (ROM) is measured at wrist, elbow, shoulder, and trunk. Qualitative observations of motor performance during functional tasks are also recorded. Assessment is performed with both the conventional and the co-designed orthosis.
Time frame
Baseline and up to 12 months2
Patient and caregiver experience of the co-design process as assessed by semi-structured interview at final visit
A semi-structured interview with open-ended questions is conducted individually with the child and caregiver at the final visit. It explores four domains: (1) enjoyment and engagement in co-design activities; (2) aesthetic, functional, and emotional satisfaction with the final orthosis; (3) positive or negative emotions associated with the process and orthosis use; (4) suggestions for future improvements. Responses are qualitatively coded and analyzed descriptively.
Time frame
Up to 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
IRCCS Eugenio Medea
Lead sponsor
Politecnico di Milano
Collaborator
Barbieri S.p.A. - Progettiamo Autonomia
Collaborator
Source ClinicalTrials.gov