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

Plain Language Summary

Simplified for easier understanding

This study tests custom-made ankle-foot orthoses (AFOs — rigid braces worn on the lower leg and foot) built using 3D scanning and digital manufacturing, compared to the traditional plaster casting method. The study is for children with a physical disability who already wear these braces. You may be eligible if: - Your child is aged 2 to 8 - Your child has a confirmed physical disability diagnosis - Your child can walk 10 metres independently without walking aids - Your child has worn traditionally made AFOs for at least 6 months - Your child has not had botox in the past 9 months and is not expected to during the trial You may NOT be eligible if: - Your child does not meet all of the inclusion criteria - Your child has a medical condition that makes AFO use inadvisable - Your child cannot attend follow-up visits in person at the trial site in Australia Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.