Status:
COMPLETED
3D Printed Orthotics in Children Adolescents
Lead Sponsor:
Barts & The London NHS Trust
Collaborating Sponsors:
Andiamo
Innovate UK
Conditions:
Cerebral Palsy
Ankle Foot Orthosis (AFO)
Eligibility:
All Genders
3-16 years
Brief 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 cer...
Detailed Description
Children with cerebral palsy often require orthotics or external braces to help them function and to manage or decrease pain, for example an ankle-foot orthoses (AFO). AFOs are orthotics worn on the f...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 31 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2019
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03770949
Start Date
July 31 2018
End Date
September 1 2019
Last Update
February 14 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Barts Health NHS Trust, Royal London Hospital
London, United Kingdom, E1 1BB