RecruitingACTRN12617001636347

Protocol for Clinical Trial of Digitally Fabricated Ankle & Foot Orthoses for Children aged 2-8 years with a Physical Disability

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?

Sponsor

AbilityMate

Enrollment

30 participants

Start Date

Jun 22, 2017

Study Type

Interventional

Conditions

Physical Disability

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.

Eligibility

Sex: Both males and femalesMin Age: 2 YearssMax Age: 8 Yearss

Inclusion Criteria9

The child is aged 2-8 years and has a definitive disability diagnosis; and
Functional Mobility at a GMFCS score of 1, 2 or equivalent
The child has the ability to walk 10 meters independently, without the use of
aides, and without the assistance of others
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.
Previous history of wearing traditionally manufactured AFOs worn for a minimum of 6 months prior to study enrolment.
Contraindicated medical conditions as assessed by the Orthotists
Medical conditions deemed high risk by Orthotists / Investigator
Participants unable to attend in person follow ups at the trial site in Australia.

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Interventions

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.