Apply to participate a Clinical Trial of Digitally Fabricated (3D Printed) Ankle Foot Orthoses
We are looking for 20-30 families to be part of the clinical trial. If your child is 2-8 years old, fits the inclusion criteria below, and can make it to Sydney please apply below
WHAT IS THIS ALL ABOUT?
Please see overview video below:
Please note this video was made before many of our collaborators came onboard and does not yet reflect all the amazing people contributing to this study!
WHO IS CONDUCTING THE STUDY?
The study is a collaboration between AbilityMate and 6 other impact-focused organisations:
AbilityMate is sponsoring the clinical trial and developing the technology . The study investigation's and prescription's will be conducted by two highly experienced and respected Orthotists, Merrick Smith from Korthotics and Vandeth Chhun from Northcott. Northcott Innovation will be co-ordinating participants. Mobius Medical is providing oversight in accordance with Australian Good Clinical Practise guidelines. Robohand Australia and Cerebral Palsy Alliance are supporting the clinical trial also.
The clinical trial has been reviewed and approved by Nepean Blue Mountains Local Health District Human Research Ethics Committee and been given project ID HREC/17/NEPEAN/35. Is it being conducted as per Australian GCP (Good Clinical Practice) and ISO 14155.
WHO IS INVITED TO ENTER THIS STUDY?
In order to collect clinically valid outcomes we have a very specific criteria for children in the study. We are looking for children who:
- Are aged between 2-8 years and has a definitive disability diagnosis; and
- Functional Mobility at a GMFCS score of 1, 2 or equivalent;
- Has the ability to walk 10 meters independently, without the use of aides, and without the assistance of others
- Have not received botox treatment 9 months prior to trial start date; and/or expected to receive botox treatment during the 7 month trial period.
- Has been prescribed and worn Ankle Foot Orthotics before
WHAT WILL HAPPEN, AND WHAT WILL BE REQUIRED?
The trial site is Korthotics in Guildford, Sydney Australia.
You will required to read and sign an information and consent form which will be provided upon expression of interest. Approximately 3 visits to a clinic will be required. Your child will be treated by two highly respected Orthotists, and will receive a pair of custom-made 3D Printed AFO's to wear for 6 months.
If your child didn't meet this criteria, please be assured that we aim to make 3D Printed AFOs available to all children soon. Please leave your email address, and we will keep you updated on progress, and let you know as soon as the service becomes widely available!
Or if you want to talk to a human about this, feel free to contact Participant Co-Ordinator Samantha Frain
of Northcott Innovation on:
Phone: 02 9890 0510 | Mobile: 0438 373 336 | Email: email@example.com