PRINT

• Research type

  Research Study

• Full title

  The feasibility and acceptability of 3D printed orthotics in children and adolescents

• IRAS ID

  233504

• Contact name

  Manoj Ramachandran

• Contact email

  Manoj.Ramachandran@bartshealth.nhs.uk

• Sponsor organisation

  Barts Health NHS Trust

• Clinicaltrials.gov Identifier

  NCT03770949

• Duration of Study in the UK

  1 years, 6 months, 1 days

• Research summary

  Many children and adolescents wear braces such as an ankle foot orthotic (AFO). An AFO maintains the ankle in the correct position to allow for easier walking, playing sport, or keeping up with peers. AFO’s are commonly worn by children and adolescents with cerebral palsy that have tight calf muscles limiting ankle movement.

  The standard process for receiving braces is to be referred to an orthotist, the professional that measures, develops, and fits the brace. The orthotist makes a plaster cast of the lower leg, ankle, and foot which is used to make a handmade brace. After the brace is made the patient attends an additional appointment to assess fit; the orthotist makes adjustments as needed. This process can be lengthy taking anywhere from a few weeks to three months, requiring multiple appointments to achieve proper fit.
  
  The development of 3D printing can be applied to brace manufacturing. A 3D printed brace can be developed using a painless 3D scan of the body. The time from scanning to brace fitting can be within three weeks. The 3D printed material is lighter than standard material decreasing the effort needed for movement. Manufacturing error is estimated at 1-3 mm for 3D printing compared to 10-20 mm with standard hand manufacturing, potentially providing a better fit with the 3D brace. 3D printed braces have the potential to improve brace development, fit, and delivery.

  The purpose of this study is to explore the feasibility and acceptability of providing children and young people with cerebral palsy with 3D printed AFO's. This study will be an interventional mixed methods study.

• REC name

  HSC REC B

• REC reference

  18/NI/0121

• Date of REC Opinion

  19 Jun 2018

• REC opinion

  Favourable Opinion