3D Printed Orthotics in Children Adolescents

NCT03770949 | Completed DMC

• 1 other identifier: 233504
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy; Ankle Foot Orthosis (AFO)

Keywords

3-D printing; Children; Adolescents

Outcome Measures

Primary Outcomes (1)

• Interviews

  Semi-structured interviews with participants and their parents/guardians will be completed to explore the experience of being fitted for and receiving a 3-D printed AFO. Interviews will be analyzed using framework analysis, findings will be reported as common themes identified throughout the interviews. Interviews will last approximately 20-30 minutes.

  Interviews will be conducted at visit 4 (9 weeks).

Secondary Outcomes (9)

• Pediatric Quality of Life Inventory TM: PedsQL

  PedsQL assessed at visit 1 (baseline), 3 (6 weeks), and 4 (9 weeks).

• Timed Up and Go Test (TUG)

  The TUG will be assessed at visit 1 (baseline), 3 (6 weeks), and 4 (9 weeks).

• Range of Motion Assessment

  ROM assessment will be completed at visit 1 (baseline), 3 (6 weeks), and 4 (9 weeks).

• Resource use/clinical data: previous ankle foot orthoses

  The resource use and clinical data will be assessed at visit 4 (9 weeks).

• Resource use/clinical data: Gross Motor Function Classification System

  The resource use and clinical data will be assessed at visit 4 (9 weeks) and during screening of patients..

Interventions

3-D Printed Orthotic (Ankle Foot Orthosis) DEVICE

Participants will receive a custom individual 3-D printed ankle foot orthosis (AFO).

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Barts & The London NHS Trust: lead
• Andiamo: collaborator
• Innovate UK: collaborator

Study Sites (1)

Barts Health NHS Trust, Royal London Hospital

London, E1 1BB, United Kingdom

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2018
• First Posted: December 10, 2018
• Study Start: July 31, 2018
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: February 14, 2023

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)