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?

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12617001636347

Acronym

AM-CIP-01

Enrollment

Registered

2017-12-18

Start date

2017-06-22

Completion date

2017-12-31

Last updated

2018-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

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.

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

2 Years to 8 Years

Healthy volunteers

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.

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.

Outcome results