3D Printed Orthotics in Children Adolescents
Condition: Cerebral Palsy; Ankle Foot Orthosis (AFO)
MeSH terms: Cerebral Palsy
Study type: Observational

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.
    

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 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 wait times and delays in
      receiving the orthotic which can impact on the fit of the orthotic. An ill-fitting orthosis
      can lead to impaired skin integrity, pain, further disability, non-compliance with wearing
      the orthosis, and potential surgery. To overcome these issues technological advances have led
      to 3-D printed orthotics.

      Advantages of 3-D printed orthotics encompass: 0.5-2mm tolerances compared to 10-20mm
      tolerances in hand manufacturing, lighter materials which decrease the energy needed for
      mobility such as walking, scanning technology to develop the AFO provides better accuracy,
      and faster times from scanning to receiving the orthotic. Additionally 3-D printed orthotics
      allow for more personalisation, and different contextual AFO designs such as a specific AFO
      for sport.

      PRINT is a mixed methods study exploring the experience of children and adolescents with
      cerebral palsy of receiving and wearing a 3-D printed AFO. Children and adolescents will be
      recruited from the Royal London Hospital pediatric department. Participants will receive
      their standard thermoplastic AFO (if the study coincides with their need for a new AFO) and a
      3-D printed AFO. Participants will wear their 3-D printed AFO for the duration of the study.

      The study aims to explore the participants and their parents/guardians experience of getting
      the 3-D printed AFO, wearing the AFO, and any impact on their lifestyle or function. This
      experience will be explored through semi-structured interviews with the child/adolescent and
      their parent/guardian. The study is also collecting data regarding: fit, comfort, skin
      integrity, durability of the AFO material, functional outcome measures, and quality of life.

      Participants will attend four assessments/visits over the course of the study. Visit 1
      encompasses baseline assessments and a painless foot and ankle scan. The foot and ankle scan
      will be used to develop the 3-D printed AFO. Up to three weeks after visit 1 the participants
      will attend visit 2 in which they will receive the 3-D printed AFO; the AFO will be assessed
      for fit and any adjustments will be made. Participants will wear the AFO for three weeks at
      which point they will attend visit 3. Visit 3 will encompass re-assessment of baseline
      measures, AFO fit, and assessment skin integrity. If participants have no issues they will
      continue to wear the 3-D printed AFO for another three weeks. If a participant is having
      issues or pain resulting from the 3-D printed AFO they will be instructed to wear their
      standard thermoplastic AFO for the next three weeks if available (remaining in the study).
      After wearing the AFO for an additional three weeks (three weeks from visit 3), participants
      will attend the final visit, visit 4. Visit 4 encompasses re-assessment of baseline measures,
      a resource use questionnaire, and an interview to explore the experience of being fitted for
      and wearing a 3-D printed AFO.
    

Intervention name(s): 3-D Printed Orthotic (Ankle Foot Orthosis)
Intervention type(s): Device
Intervention description(s): Participants will receive a custom individual 3-D printed ankle foot orthosis (AFO).
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children and adolescents 3-16 years of age who have cerebral palsy, have been previously
        prescribed and worn a standard thermoplastic AFO for maintenance of ankle position.
      
Keywords: 3-D printing; Children; Adolescents