Cerebral PalsyPRINTNCT03770949
3D Printed Orthotics in Children Adolescents
An observational study of Cerebral Palsy and Ankle Foot Orthosis (AFO), run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 16 years
- Conditions the study is for
- Cerebral Palsy, Ankle Foot Orthosis (AFO)
- What is being tested?
- 3-D Printed Orthotic (Ankle Foot Orthosis)
- Type of treatment
- Medical device
- How many people
- 17 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Jul 2018to 1 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 16 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Barts Health NHS Trust, Royal London Hospital
London, E1 1BB
About this study
Official title: The Feasibility and Acceptability of 3D Printed Orthotics in Children and Adolescents
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.
Read the 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.
- Conditions
- Cerebral Palsy, Ankle Foot Orthosis (AFO)
- Being tested
- 3-D Printed Orthotic (Ankle Foot Orthosis)
- Keywords
- 3-D printing, Children, Adolescents
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-D Printed Orthotic (Ankle Foot Orthosis)Device
Participants will receive a custom individual 3-D printed ankle foot orthosis (AFO).
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Interviews will be conducted at visit 4 (9 weeks).
Secondary outcomes (9)
Pediatric Quality of Life Inventory TM: PedsQL
Self-reported assessment of quality of life will be assessed using the PedsQL. The PedsQL encompasses functional tasks, feelings/emotions, how someone gets on with others, school activities, and participation. The PedsQL has both child report and parent proxy report; there are different questionnaires for different age groups ranging from toddlers to adolescents. Questions are scored on a 5 point Likert scale from 0 to 4; higher scores indicate better health related quality of life.The PedsQL will take approximately 5-10 minutes to complete.
Measured: PedsQL assessed at visit 1 (baseline), 3 (6 weeks), and 4 (9 weeks).
Timed Up and Go Test (TUG)
The TUG is a functional assessment evaluating sit-stand, ambulation, and turning. The participant starts from a seated position, on 'go' the participant rises from the chair, walks 3 meters turns, walks back to the chair and sits. The test is timed from 'go' to when the participant is back seated in the chair to the nearest centisecond for example 13.46 seconds. This assessment can be done with and with out assistive devices such as walkers or crutches. Faster times are associated with better functional mobility. Three trials will be completed. The TUG will take around 10 minutes to complete.
Measured: The TUG will be assessed at visit 1 (baseline), 3 (6 weeks), and 4 (9 weeks).
Range of Motion Assessment
Ankle range of motion (ROM) will be assessed using a goniometer, the gold standard in range of motion assessment. The ankle motions assessed are dorsiflexion and plantar flexion to the nearest degree. Three measurement trials will be completed. Ankle range of motion will take approximately 5 minutes to complete.
Measured: ROM assessment will be completed at visit 1 (baseline), 3 (6 weeks), and 4 (9 weeks).
Resource use/clinical data: previous ankle foot orthoses
Participants and their parents/guardians will complete a questionnaire regarding resource use and clinical data such as previous AFO's recording the number of previous AFO's the participant has had.
Measured: The resource use and clinical data will be assessed at visit 4 (9 weeks).
Resource use/clinical data: Gross Motor Function Classification System
Participants and their parents/guardians will complete a questionnaire of resource use and clinical data including reporting the participants Gross Motor Function Classification System (GMFCS) which assesses the individuals motor function. The GMFCS level will be the level the individuals scored at their most recent assessment, obtained from participant/guardian report or chart review. GMFCS levels range from I-V; lower levels are associated with higher functioning.
Measured: The resource use and clinical data will be assessed at visit 4 (9 weeks) and during screening of patients..
Resource use/clinical data: number of fitting appointments
Participants and their parents/guardians will complete a questionnaire of resource use and clinical data including the number of fitting appointments attended to achieve proper AFO fit. This will be done by recording the number of fitting appointments for both the 3-D printed AFO and previous standard AFO's the participant has had.
Measured: The resource use and clinical data will be assessed at visit 4 (9 weeks).
Resource use/clinical data: compliance wearing the AFO
Participants and their parents/guardians will complete a questionnaire regarding resource use and clinical data with questions around compliance with wearing the AFO measured as "yes" compliant with the amount of time prescribed to wear AFO; or "no" not complaint with the amount of team prescribed to wear the AFO and reasons why not complaint (open ended question participant generates their own response).
Measured: The resource use and clinical data will be assessed at visit 4 (9 weeks).
Resource use/clinical data: skin integrity
Participants and their parents/guardians will complete a questionnaire regarding resource use and clinical data with questions around skin integrity (redness, rubbing, skin breakdown) whilst wearing the 3-D printed AFO.
Measured: The resource use and clinical data will be assessed at visit 4 (9 weeks).
3-D scanning of the lower limb
The foot and ankle will be scanned using an Artec Eva scanner on a Microsoft Surface 4 tablet with Windows 10. The 3-D scan is what is used to develop and generate the 3-D printed AFO.
During scanning the tablet camera is used to take a 3-D scan/image of the lower leg, ankle, and foot. The participant does not have to do anything during the 3-D scan. The participant's foot will be placed in the optimal position for the scan and the tablet camera will be moved around the participants' leg and foot to obtain the 3-D image. The 3-D scan is painless and takes around fifteen minutes.
There are no specific measurements associated with the scanning.
Measured: Visit 1 (baseline assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study start31 Jul 2018
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Andiamo, Innovate UK
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03770949
- Sponsor's protocol ID
- 233504
- Acronym
- Status last verified
- Nov 2018
- First submitted
- 23 Nov 2018
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: n/a no plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility and Acceptability of 3D Printed Orthotics in Children and Adolescents
- ClinicalTrials.gov ID
- NCT03770949
- Acronym / sponsor ID
- PRINT / 233504
- Conditions
- Cerebral Palsy, Ankle Foot Orthosis (AFO)
- Keywords
- 3-D printing, Children, Adolescents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Collaborators
- Andiamo, Innovate UK
- Study start
- 31 Jul 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 10 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3-D Printed Orthotic (Ankle Foot Orthosis)Participants will receive a custom individual 3-D printed ankle foot orthosis (AFO). | Device | – |
Primary outcome
Interviews
Time frame: Interviews will be conducted at visit 4 (9 weeks).
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.
9 secondary outcomes
Pediatric Quality of Life Inventory TM: PedsQL
Time frame: PedsQL assessed at visit 1 (baseline), 3 (6 weeks), and 4 (9 weeks).
Timed Up and Go Test (TUG)
Time frame: The TUG will be assessed at visit 1 (baseline), 3 (6 weeks), and 4 (9 weeks).
Range of Motion Assessment
Time frame: ROM assessment will be completed at visit 1 (baseline), 3 (6 weeks), and 4 (9 weeks).
Resource use/clinical data: previous ankle foot orthoses
Time frame: The resource use and clinical data will be assessed at visit 4 (9 weeks).
Resource use/clinical data: Gross Motor Function Classification System
Time frame: The resource use and clinical data will be assessed at visit 4 (9 weeks) and during screening of patients..
Resource use/clinical data: number of fitting appointments
Time frame: The resource use and clinical data will be assessed at visit 4 (9 weeks).
Resource use/clinical data: compliance wearing the AFO
Time frame: The resource use and clinical data will be assessed at visit 4 (9 weeks).
Resource use/clinical data: skin integrity
Time frame: The resource use and clinical data will be assessed at visit 4 (9 weeks).
3-D scanning of the lower limb
Time frame: Visit 1 (baseline assessment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Individual participant dataSharing planned: No. n/a no plan to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Ankle Foot Orthosis (AFO), run by Barts & The London NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interviews (time frame: Interviews will be conducted at visit 4 (9 weeks).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.