Clinical trial NCT03770949: 3D Printed Orthotics in Children Adolescents
Official title: The Feasibility and Acceptability of 3D Printed Orthotics in Children and Adolescents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Ankle Foot Orthosis (AFO)
Keywords: 3-D printing
Children
Adolescents
Lead sponsor: Barts & The London NHS Trust
Sponsor class: OTHER
Collaborators: name: Andiamo
name: Innovate UK
First posted: 2018-12-10
Enrollment: 17
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
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.

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 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.

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

Primary outcomes:
measure: Interviews
timeFrame: Interviews will be conducted at visit 4 (9 weeks).
Secondary outcomes:
measure: Pediatric Quality of Life Inventory TM: PedsQL
timeFrame: PedsQL assessed at visit 1 (baseline), 3 (6 weeks), and 4 (9 weeks).
measure: Timed Up and Go Test (TUG)
timeFrame: The TUG will be assessed at visit 1 (baseline), 3 (6 weeks), and 4 (9 weeks).
measure: Range of Motion Assessment
timeFrame: ROM assessment will be completed at visit 1 (baseline), 3 (6 weeks), and 4 (9 weeks).
measure: Resource use/clinical data: previous ankle foot orthoses
timeFrame: The resource use and clinical data will be assessed at visit 4 (9 weeks).
measure: Resource use/clinical data: Gross Motor Function Classification System
timeFrame: The resource use and clinical data will be assessed at visit 4 (9 weeks) and during screening of patients..
measure: Resource use/clinical data: number of fitting appointments
timeFrame: The resource use and clinical data will be assessed at visit 4 (9 weeks).
measure: Resource use/clinical data: compliance wearing the AFO
timeFrame: The resource use and clinical data will be assessed at visit 4 (9 weeks).
measure: Resource use/clinical data: skin integrity
timeFrame: The resource use and clinical data will be assessed at visit 4 (9 weeks).
measure: 3-D scanning of the lower limb
timeFrame: Visit 1 (baseline assessment)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Barts Health NHS Trust, Royal London Hospital
Study officials:
References: