3D Printed Orthotics in Children Adolescents
Launched by BARTS & THE LONDON NHS TRUST · Dec 7, 2018
Trial Information
Current as of May 08, 2025
Completed
Keywords
ClinConnect Summary
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 foot and ankle to maintain the ankle in an optimal position to treat and manage spastic equinus; the AFO can help the child stand, walk, and interact with their peers. AFOs can also prevent muscles and tendons from further tightening and shortening which can contribute to pain, discomfort, loss of range of motion, and disability.
Current thermoplastic orthotic services are expensive, have long ...
Gender
ALL
Eligibility criteria
- 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
About Barts & The London Nhs Trust
Barts and The London NHS Trust is a leading healthcare organization in the United Kingdom, renowned for its commitment to delivering high-quality clinical care, research, and education. As a prominent sponsor of clinical trials, the Trust is dedicated to advancing medical knowledge and improving patient outcomes through innovative research initiatives. With a focus on patient safety and ethical standards, Barts and The London NHS Trust collaborates with multidisciplinary teams to explore cutting-edge therapies and interventions across various medical fields, ensuring that trial participants receive the highest level of care and support throughout their involvement.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
London, , United Kingdom
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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