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Trial registered on ANZCTR


Registration number
ACTRN12618000558224
Ethics application status
Approved
Date submitted
23/03/2018
Date registered
13/04/2018
Date last updated
22/03/2019
Date data sharing statement initially provided
22/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Personalised 3D printed ankle-foot orthoses for children and adolescents with Charcot-Marie-Tooth disease (printhotics™ trial)
Scientific title
Effect of personalised 3D printed vs. traditional handmade ankle-foot orthoses on walking ability for children with Charcot-Marie-Tooth disease: a pilot crossover randomised controlled trial (printhotics™ trial)
Secondary ID [1] 294336 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Charcot-Marie-Tooth disease 307055 0
Condition category
Condition code
Human Genetics and Inherited Disorders 306164 306164 0 0
Other human genetics and inherited disorders
Musculoskeletal 306165 306165 0 0
Other muscular and skeletal disorders
Neurological 306166 306166 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The three ankle-foot orthosis (AFO) designs will be evaluated, traditional AFO, replicated 3D printed AFO (same design as traditional AFO) and optimised 3D printed AFO (design only achieved through 3D printing), and compared to a shoe only condition. Each AFO design will be worn on both legs. Traditional AFOs will be manufactured by an Orthotist from a plaster cast of the participants lower limb followed by thermoplastic vaccum forming. The positive plaster cast mould will then be digitised using a 3D surface scanner to create a 3D model. Computer aided models of a replicated AFO and optimised AFO will then be generated from the 3D model and manufactured using a 3D printer. 3D gait analysis and inshoe pedobarography data will be collected to assess differences in walking in the gait lab of the Paedatric Gait Analysis Service of NSW by a Biomedical Engineer with over 6 years experience in clinical gait analysis. The participant will also be asked to complete a patient satisfaction questionnaire on each AFO condition. The testing order of the four conditions will be randomised for each participant. Each condition will take approximately 30 minutes to test with a 5 minute break in between.
Intervention code [1] 300664 0
Treatment: Devices
Comparator / control treatment
Each device will be worn in the same shoe for testing and compared to the shoe only condition (Dunlop Volley). This shoe has thin and flexible rubber soles, light weight construction and minimal cushioning and supportive features are considered to have minimal effect on foot function.
Control group
Active

Outcomes
Primary outcome [1] 305207 0
Effect on foot drop measured by 3D gait analysis
Timepoint [1] 305207 0
6 weeks from enrollment and 5 minutes post placement of each AFO
Secondary outcome [1] 344502 0
Walking speed measured by 3D gait analysis

Timepoint [1] 344502 0
6 weeks from enrollment and 5 minutes post placement of each AFO
Secondary outcome [2] 344503 0
Stride length measured by 3D gait analysis
Timepoint [2] 344503 0
6 weeks from enrollment and 5 minutes post placement of each AFO
Secondary outcome [3] 344925 0
Cadence measure by 3D gait analysis
Timepoint [3] 344925 0
6 weeks from enrollment and 5 minutes post placement of each AFO
Secondary outcome [4] 344926 0
Plantar pressure measured using inshoe pedobarograpahy
Timepoint [4] 344926 0
6 weeks from enrollment and 5 minutes post placement of each AFO
Secondary outcome [5] 344927 0
Patient satisfaction measured using a child version of the Client Satisfaction with Device module of the Orthotics and Prosthetic Users’ Survey
Timepoint [5] 344927 0
6 weeks from enrollment and 30 minutes post placement of each AFO
Secondary outcome [6] 345134 0
Gait profile score measured by 3D gait analysis
Timepoint [6] 345134 0
6 weeks from enrollment and 5 minutes post placement of each AFO
Secondary outcome [7] 345135 0
Ankle gait variable score measured by 3D gait analysis
Timepoint [7] 345135 0
6 weeks from enrollment and 5 minutes post placement of each AFO
Secondary outcome [8] 345137 0
Maximum ankle dorsiflexion in stance
Timepoint [8] 345137 0
6 weeks from enrollment and 5 minutes post placement of each AFO
Secondary outcome [9] 345138 0
Timing of maximum ankle dorsiflexion in stance as a percentage of the gait cycle
Timepoint [9] 345138 0
6 weeks from enrollment and 5 minutes post placement of each AFO
Secondary outcome [10] 345139 0
Maximum ankle plantarflexion at push-off
Timepoint [10] 345139 0
6 weeks from enrollment and 5 minutes post placement of each AFO
Secondary outcome [11] 345140 0
Maximum ankle dorsiflexion in swing
Timepoint [11] 345140 0
6 weeks from enrollment and 5 minutes post placement of each AFO
Secondary outcome [12] 345141 0
Maximum ankle dorsiflexion in the last 1/3rd swing
Timepoint [12] 345141 0
6 weeks from enrollment and 5 minutes post placement of each AFO
Secondary outcome [13] 345142 0
Ankle dorsiflexion at initial contact
Timepoint [13] 345142 0
6 weeks from enrollment and 5 minutes post placement of each AFO
Secondary outcome [14] 345143 0
Foot progression angle at 25%
Timepoint [14] 345143 0
6 weeks from enrollment and 5 minutes post placement of each AFO
Secondary outcome [15] 345144 0
Thigh-foot angle at 25%
Timepoint [15] 345144 0
6 weeks from enrollment and 5 minutes post placement of each AFO
Secondary outcome [16] 345145 0
Maximum ankle dorsiflexor moment in loading response
Timepoint [16] 345145 0
6 weeks from enrollment and 5 minutes post placement of each AFO
Secondary outcome [17] 345146 0
Maximum ankle plantarflexor moment
Timepoint [17] 345146 0
6 weeks from enrollment and 5 minutes post placement of each AFO
Secondary outcome [18] 345147 0
Maximum ankle power at push-off
Timepoint [18] 345147 0
6 weeks from enrollment and 5 minutes post placement of each AFO
Secondary outcome [19] 345148 0
Maximum ankle power generation in mid-stance
Timepoint [19] 345148 0
6 weeks from enrollment and 5 minutes post placement of each AFO
Secondary outcome [20] 345149 0
Knee flexion at initial contact
Timepoint [20] 345149 0
6 weeks from enrollment and 5 minutes post placement of each AFO
Secondary outcome [21] 345150 0
Maximum knee flexion in loading response
Timepoint [21] 345150 0
6 weeks from enrollment and 5 minutes post placement of each AFO
Secondary outcome [22] 345151 0
Minimum knee flexion in stance
Timepoint [22] 345151 0
6 weeks from enrollment and 5 minutes post placement of each AFO
Secondary outcome [23] 345152 0
Maximum knee flexion in swing
Timepoint [23] 345152 0
6 weeks from enrollment and 5 minutes post placement of each AFO
Secondary outcome [24] 345153 0
Maximum knee flexor moment in single-support
Timepoint [24] 345153 0
6 weeks from enrollment and 5 minutes post placement of each AFO
Secondary outcome [25] 345154 0
Maximum knee extensor moment in stance
Timepoint [25] 345154 0
6 weeks from enrollment and 5 minutes post placement of each AFO
Secondary outcome [26] 345155 0
Mean sagittal plane knee moment in stance
Timepoint [26] 345155 0
6 weeks from enrollment and 5 minutes post placement of each AFO
Secondary outcome [27] 345156 0
Minimum hip flexion
Timepoint [27] 345156 0
6 weeks from enrollment and 5 minutes post placement of each AFO
Secondary outcome [28] 345157 0
Maximum hip flexion in swing
Timepoint [28] 345157 0
6 weeks from enrollment and 5 minutes post placement of each AFO
Secondary outcome [29] 345158 0
Hip flexion range of motion during swing (max in swing - initial contact)
Timepoint [29] 345158 0
6 weeks from enrollment and 5 minutes post placement of each AFO
Secondary outcome [30] 345159 0
Maximum hip adduction in stance
Timepoint [30] 345159 0
6 weeks from enrollment and 5 minutes post placement of each AFO
Secondary outcome [31] 345160 0
Maximum hip adduction in swing
Timepoint [31] 345160 0
6 weeks from enrollment and 5 minutes post placement of each AFO
Secondary outcome [32] 345161 0
Hip rotation in at 25%
Timepoint [32] 345161 0
6 weeks from enrollment and 5 minutes post placement of each AFO
Secondary outcome [33] 345162 0
Maximum hip abductor moment in terminal stance
Timepoint [33] 345162 0
6 weeks from enrollment and 5 minutes post placement of each AFO
Secondary outcome [34] 345163 0
Maximum pelvic tilt
Timepoint [34] 345163 0
6 weeks from enrollment and 5 minutes post placement of each AFO
Secondary outcome [35] 345164 0
Maximum pelvic obliquity in swing
Timepoint [35] 345164 0
6 weeks from enrollment and 5 minutes post placement of each AFO
Secondary outcome [36] 345165 0
Pelvic obliquity range of motion in swing
Timepoint [36] 345165 0
6 weeks from enrollment and 5 minutes post placement of each AFO
Secondary outcome [37] 345166 0
Pelvic rotation at 25%
Timepoint [37] 345166 0
6 weeks from enrollment and 5 minutes post placement of each AFO

Eligibility
Key inclusion criteria
Children aged 5-16 years with a confirmed diagnosis of Charcot-Marie-Tooth disease, currently using or functionally indicated (foot drop during gait by observation) for bilateral ankle-foot orthoses.
Minimum age
5 Years
Maximum age
16 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to give informed consent, understand English, a diagnosis other than Charcot-Marie-Tooth disease (CMT), unable to walk 100 metres in shoes.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Data on the shoe condition will be collected first. The testing order of the three AFO conditions will then be randomised for each participant allowing all possible sequences to be completed twice. This will be completed prior to data collection by the co-ordinating investigator.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
All participants will receive each test condition on both legs.
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 10401 0
The Children's Hospital at Westmead - Westmead
Recruitment postcode(s) [1] 22086 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 298978 0
Government body
Name [1] 298978 0
Department of Education and Training
Address [1] 298978 0
Department of Education and Training
GPO Box 9880
Canberra ACT 2601
Country [1] 298978 0
Australia
Funding source category [2] 299003 0
Charities/Societies/Foundations
Name [2] 299003 0
Charcot-Marie-Tooth Association of Australia
Address [2] 299003 0
Building 22
Concord Hospital
Hospital Rd
Concord NSW 2139


Country [2] 299003 0
Australia
Funding source category [3] 299004 0
University
Name [3] 299004 0
University of Sydney
Address [3] 299004 0
Commercial Development & Industry Partnerships (Industry and Community Engagement Seed Fund)
Level 6 Jane Foss Russell Building (G02)
City Road
University of Sydney NSW 2006

Country [3] 299004 0
Australia
Primary sponsor type
Individual
Name
Professor Joshua Burns
Address
The Children's Hospital at Westmead
Locked Bag 4001
Westmead 2145 NSW
Country
Australia
Secondary sponsor category [1] 298336 0
None
Name [1] 298336 0
Address [1] 298336 0
Country [1] 298336 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299908 0
Sydney Childrens Hospitals Network Human Research Ethics Committee
Ethics committee address [1] 299908 0
Research Ethics Manager
Research Office
The Children's Hospital at Westmead
Locked Bag 4001
Westmead, 2145, NSW
Ethics committee country [1] 299908 0
Australia
Date submitted for ethics approval [1] 299908 0
29/03/2018
Approval date [1] 299908 0
04/06/2018
Ethics approval number [1] 299908 0

Summary
Brief summary
The aim of this project is to evaluate 3D printed AFOs compared to traditional handmade AFOs in children and adolescents with Charcot-Marie-Tooth disease (CMT) during walking. Three AFO designs will be evaluated traditional AFO, replicated 3D printed AFO and optimised 3D printed AFO and compared to a shoe only condition. Traditional AFOs will be handmade by an Orthotist from plaster casting methods of the participant’s lower limb followed by thermoplastic vaccum forming. The positive plaster cast mould will then be digitised using a 3D surface scanner to create a 3D model. Computer aided models of a replicated AFO and optimised AFO will then be generated from the 3D model and manufactured using the state of the art 3D printer. 3D gait analysis and inshoe plantar pressure data will be collected to assess differences in walking.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81954 0
Prof Joshua Burns
Address 81954 0
The Children's Hospital at Westmead
Locked Bag 4001
Westmead, 2145, NSW
Country 81954 0
Australia
Phone 81954 0
+61290367302
Fax 81954 0
Email 81954 0
joshua.burns@health.nsw.gov.au
Contact person for public queries
Name 81955 0
Miss Elizabeth Wojciechowski
Address 81955 0
The Children's Hospital at Westmead
Locked Bag 4001
Westmead, 2145, NSW
Country 81955 0
Australia
Phone 81955 0
+61298452985
Fax 81955 0
Email 81955 0
elizabeth.wojciechowski@health.nsw.gov.au
Contact person for scientific queries
Name 81956 0
Miss Elizabeth Wojciechowski
Address 81956 0
The Children's Hospital at Westmead
Locked Bag 4001
Westmead, 2145, NSW
Country 81956 0
Australia
Phone 81956 0
+61298452985
Fax 81956 0
Email 81956 0
elizabeth.wojciechowski@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To protect intellectual property associated with this trial.
What supporting documents are/will be available?
No other documents available
Summary results
No Results