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Trial registered on ANZCTR


Registration number
ACTRN12617001636347
Ethics application status
Approved
Date submitted
26/10/2017
Date registered
18/12/2017
Date last updated
26/03/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Protocol for Clinical Trial of Digitally Fabricated Ankle & Foot Orthoses for Children aged 2-8 years with a Physical Disability
Scientific title
Protocol for Clinical Trial of Digitally Fabricated Ankle & Foot Orthoses for Children aged 2-8 years with a Physical Disability - Are they a Biomechnically Viable Alternative to Traditionally Manufactured Ankle & Foot Orthoses?
Secondary ID [1] 293222 0
NIL
Universal Trial Number (UTN)
Trial acronym
AM-CIP-01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical Disability 305240 0
Condition category
Condition code
Neurological 304545 304545 0 0
Other neurological disorders
Musculoskeletal 304546 304546 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Clinical study of 20-30 participants who will receive and wear Ankle Foot Orthosis (AFO) manufactured through a digital process. AFO is a brace that is worn on the lower leg and foot to support the ankle, hold the foot and ankle in the correct position and correct foot drop. AFO used in this trial will be manufactured by the use of three-dimensional scanning technology along with the computer-aided design and additive manufacturing technologies (selective laser sintering). AFOs will be personalised to each participants based on the measurements obtained from 3-Dimensional scanning. The participants will be required to wear the AFOs for 6 months and be asked to gradually wear the AFOs as follows: Day 1 - 1 Hour in AM, Day 2 - 1 Hour in AM, 1 Hour in PM, Day 3 - 1.5 Hours in AM, 1.5 Hours in PM, Day 4 - 2 Hours in AM, 2 Hours in PM, Day 5 - 2.5 Hours in AM, 2.5 Hours in PM and Day 6 and After - All Waking Hours.

Unlike traditional AFOs, this investigational product is made of Nylon 12, widely used for medical implants and has been certified as biocompatible.

The study time points are as follows: Screening/Scanning (Up to Day -15), Production (Day -14 to -1), Fitment (Day 0), Face to Face Follow Up at Week 2 and 6 Months, Phone Follow Up at 1 Month, 2 Month, 3 Month, 4 Month, 5 Month.
Intervention code [1] 299479 0
Treatment: Devices
Comparator / control treatment
The 6 months results collected from these patients using digitally manufactured AFOs will be compared against the pre-existing performance and experience data available of the same patient wearing AFOs made using the traditional method previously. AFOs are won as soon as the child is diagnosed with the physical disability.

The traditional AFOs operate the same way as the investigational product but method of manufacturing AFOs are time consuming and are made of thermoplastics comprised of polypropylene and polyethylene. The data will be collected prospectively using experience interviews with the parent's of the participants and the investigators comparing their experience of digitally manufactured AFOs to the traditional AFOs that the participants were wearing. This data will be collected prospectively for purposes of data collection.
Control group
Historical

Outcomes
Primary outcome [1] 303778 0
To explore whether AFOs manufactured through digital fabrication technology are a biomechanically viable alternative to traditionally manufactured AFOs for children aged 2-8 years with physical disabilities. This is assessed by ISPO Assessments (Gait Analysis) and phone experience interview..
Timepoint [1] 303778 0
Fitment (Day 0), Face to Face Follow Up at Week 2 and 6 Months (Primary Endpoint), 1 Month, 2 Month, 3 Month, 4 Month, 5 Month Phone Follow Up
Secondary outcome [1] 340121 0
To evaluate if 3D printed AFOs are equally as robust as traditionally manufactured AFOs when all materials undergo comparative mechanical testing. This outcome is measured by customised testing rig named Tara and comparing the robustness when bent 45 degrees at the ankle 500 degrees.
Timepoint [1] 340121 0
Production (Day -14 to -1),
Secondary outcome [2] 340122 0
The distress experienced by participants and their families when being measured for an AFO assessed by experience interviews when compared to traditional plaster casting methods. The distress levels are assessed by the experience interviews during the screening and scanning stages where they are asked if distress levels when being measured for a new AFO are lower or higher compared to the time when traditional plaster measurements were performed.
Timepoint [2] 340122 0
Screening/Scanning (Up to Day -15)
Secondary outcome [3] 340123 0
The orthotists experience with the new digital method assessed by experience questionnaire specifically designed for the trial for Orthotists compared with the traditional manufacturing method.
Timepoint [3] 340123 0
Screening/Scanning (Up to Day -15), Production (Day -14 )

Eligibility
Key inclusion criteria
1. The child is aged 2-8 years and has a definitive disability diagnosis; and
2. Functional Mobility at a GMFCS score of 1, 2 or equivalent
3. The child has the ability to walk 10 meters independently, without the use of
aides, and without the assistance of others
4. The child has not received botox treatment 9 months prior to trial start date and/or expected to receive botox treatment during the 7 month trial period.
5. Previous history of wearing traditionally manufactured AFOs worn for a minimum of 6 months prior to study enrolment.
Minimum age
2 Years
Maximum age
8 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. The child is excluded if they do not meet all inclusion criteria.
2. Contraindicated medical conditions as assessed by the Orthotists
3. Medical conditions deemed high risk by Orthotists / Investigator
4. Participants unable to attend in person follow ups at the trial site in Australia.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
22/06/2017
Date of last participant enrolment
Anticipated
31/12/2017
Actual
Date of last data collection
Anticipated
30/06/2018
Actual
Sample size
Target
30
Accrual to date
22
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 17943 0
2161 - Guildford

Funding & Sponsors
Funding source category [1] 297852 0
Government body
Name [1] 297852 0
Jobs for NSW
Country [1] 297852 0
Australia
Funding source category [2] 297853 0
Commercial sector/Industry
Name [2] 297853 0
ING Direct Grant
Country [2] 297853 0
Australia
Funding source category [3] 297854 0
Charities/Societies/Foundations
Name [3] 297854 0
Cerebral Palsy Alliance Research Foundation
Country [3] 297854 0
Australia
Primary sponsor type
Other Collaborative groups
Name
AbilityMate
Address
AbilityMate
Unit 11/83-87 Albert Street
Hornsby, NSW, 2077
Country
Australia
Secondary sponsor category [1] 296890 0
None
Name [1] 296890 0
Address [1] 296890 0
Country [1] 296890 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298900 0
Nepean Blue Mountains Local Health District HREC
Ethics committee address [1] 298900 0
Level 5 South Block
Nepean Hospital
Kingswood, NSW, 2747
Ethics committee country [1] 298900 0
Australia
Date submitted for ethics approval [1] 298900 0
13/03/2017
Approval date [1] 298900 0
12/05/2017
Ethics approval number [1] 298900 0
HREC/17/NEPEAN/35

Summary
Brief summary
This is a clinical study of 20-30 participants who will receive and wear Ankle Foot Orthosis (AFO) manufactured through a digital process using the three-dimensional scanning technology along with the computer-aided design and additive manufacturing technologies. The results collected from these patients will be compared against the pre-existing data of the same patient wearing AFOs made using the traditional method.
Trial website
http://www.abilitymate.com/#collaboration
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78594 0
Mr Merrick Smith
Address 78594 0
Korthotics Pty Ltd
45/575 Woodville Road
Guildford, NSW 2161
Country 78594 0
Australia
Phone 78594 0
+61 2 8710 4183
Fax 78594 0
Email 78594 0
[email protected]
Contact person for public queries
Name 78595 0
Johan du Plessis
Address 78595 0
AbilityMate
Unit 11/83-87 Albert Street
Hornsby, NSW, 2077
Country 78595 0
Australia
Phone 78595 0
+61 406 014 981
Fax 78595 0
Email 78595 0
[email protected]
Contact person for scientific queries
Name 78596 0
Johan du Plessis
Address 78596 0
AbilityMate
Unit 11/83-87 Albert Street
Hornsby, NSW, 2077
Country 78596 0
Australia
Phone 78596 0
+61 406 014 981
Fax 78596 0
Email 78596 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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