3D Printed Orthotics in Children Adolescents (NCT03770949) | Clinical Trial Compass
CompletedNot Applicable
3D Printed Orthotics in Children Adolescents
United Kingdom17 participantsStarted 2018-07-31
Plain-language summary
PRINT is a prospective mixed methods study exploring the feasibility and acceptability of providing 3-D printed orthotics specifically an ankle foot orthosis (AFO) to children and adolescents with cerebral palsy.
Who can participate
Age range3 Years – 16 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Children/adolescents 3-16 years of age with hemiplegia resulting from cerebral palsy who are categorized as either level 1 or level 2 as per the Gross Motor Function Classification for cerebral palsy assessed through a chart review (Children at this level will be able to participate in and complete a walking test)
* Children/adolescents with an identified clinical need for an AFO whose ankle can be held in a corrected position with minimal manual support
* Children/adolescents who are prescribed an AFO for maintenance only assessed through chart review (maintaining joint position)
* Children/adolescents who have previously been prescribed a standard thermoplastic orthotic assessed through chart review
Exclusion Criteria:
* Children/adolescents who require significant amount of manual correction to position their foot
* Children/adolescents with dystonia, spastic diplegia or total body involvement
* Children/adolescents who require bilateral orthotics
* Children/adolescents who require corrective therapy such as serial casting to stretch and reposition the foot and ankle
* Children/adolescents who are participating in another research study that may impact on ankle range of motion or calf muscle length or increase participant burden on parents/participants.
* Children/adolescents weighing more than 62kg as assessed through a chart review
* Children/adolescents that have photo-sensitivity (e.g. epilepsy) assessed through chart review
What they're measuring
1
Interviews
Timeframe: Interviews will be conducted at visit 4 (9 weeks).