Trials Sponsors Conditions Drugs Pricing

Conditions

Ankle Foot Orthosis (AFO)Cerebral Palsy

Keywords

3-D printingChildrenAdolescents

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..
+4 more secondary outcomes

Interventions

3-D Printed Orthotic (Ankle Foot Orthosis)Device

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age3 Years - 16 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

Sampling MethodNon-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)

Sponsors & Collaborators

Andiamo
Type not reportedcollaborator
Innovate UK
Governmentcollaborator
Barts & The London NHS Trust

Study Sites (1)

Barts Health NHS Trust, Royal London Hospital

London, E1 1BB, United Kingdom

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Enrollment

17 participants (actual enrollment reported by the registry).

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

Actual (reported)

3D Printed Orthotics in Children Adolescents

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations