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Search / Trial NCT03770949

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

3 D Printing Children Adolescents

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.

Locations

London, , United Kingdom

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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