Personalised 3D printed ankle-foot orthoses for children and adolescents with Charcot-Marie-Tooth disease (printhotics™ trial)

• Register: ANZCTR
• Last refreshed on: 26 July 2021
• Main ID: ACTRN12618000558224
• Date of registration: 13/04/2018
• Prospective Registration: Yes
• Primary sponsor: Professor Joshua Burns
• Public title: Personalised 3D printed ankle-foot orthoses for children and adolescents with Charcot-Marie-Tooth disease (printhotics™ trial)
• Scientific title: Effect of personalised 3D printed vs. traditional handmade ankle-foot orthoses on walking ability for children with Charcot-Marie-Tooth disease: a pilot crossover randomised controlled trial (printhotics™ trial)
• Date of first enrolment: 10/07/2018
• Target sample size: 12
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12618000558224.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Crossover;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Miss Elizabeth Wojciechowski

• Name: Miss Elizabeth Wojciechowski

Key inclusion & exclusion criteria

Inclusion criteria: Children aged 5-16 years with a confirmed diagnosis of Charcot-Marie-Tooth disease, currently using or functionally indicated (foot drop during gait by observation) for bilateral ankle-foot orthoses.
Exclusion criteria: Inability to give informed consent, understand English, a diagnosis other than Charcot-Marie-Tooth disease (CMT), unable to walk 100 metres in shoes.

Age minimum: 5 Years
Age maximum: 16 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Neurological - Other neurological disorders

Charcot-Marie-Tooth disease;
Charcot-Marie-Tooth disease

Human Genetics and Inherited Disorders - Other human genetics and inherited disorders

Musculoskeletal - Other muscular and skeletal disorders

Intervention(s)

The three ankle-foot orthosis (AFO) designs will be evaluated, traditional AFO, replicated 3D printed AFO (same design as traditional AFO) and optimised 3D printed AFO (design only achieved through 3D printing), and compared to a shoe only condition. Each AFO design will be worn on both legs. Traditional AFOs will be manufactured by an Orthotist from a plaster cast of the participants lower limb followed by thermoplastic vaccum forming. The positive plaster cast mould will then be digitised using a 3D surface scanner to create a 3D model. Computer aided models of a replicated AFO and optimised AFO will then be generated from the 3D model and manufactured using a 3D printer. 3D gait analysis and inshoe pedobarography data will be collected to assess differences in walking in the gait lab of the Paedatric Gait Analysis Service of NSW by a Biomedical Engineer with over 6 years experience in clinical gait analysis. The participant will also be asked to complete a patient satisfaction questionnaire on each AFO condition. The testing order of the four conditions will be randomised for each participant. Each condition will take approximately 30 minutes to test with a 5 minute break in between.

Primary Outcome(s)

Effect on foot drop measured by 3D gait analysis[6 weeks from enrollment and 5 minutes post placement of each AFO]

Secondary Outcome(s)

Ankle dorsiflexion at initial contact[6 weeks from enrollment and 5 minutes post placement of each AFO]

Maximum ankle plantarflexor moment[6 weeks from enrollment and 5 minutes post placement of each AFO]

Maximum ankle power generation in mid-stance[6 weeks from enrollment and 5 minutes post placement of each AFO]

Maximum hip abductor moment in terminal stance[6 weeks from enrollment and 5 minutes post placement of each AFO]

Gait profile score measured by 3D gait analysis[6 weeks from enrollment and 5 minutes post placement of each AFO]

Knee flexion at initial contact[6 weeks from enrollment and 5 minutes post placement of each AFO]

Maximum ankle dorsiflexor moment in loading response[6 weeks from enrollment and 5 minutes post placement of each AFO]

Minimum knee flexion in stance[6 weeks from enrollment and 5 minutes post placement of each AFO]

Pelvic obliquity range of motion in swing[6 weeks from enrollment and 5 minutes post placement of each AFO]

Maximum knee flexion in loading response[6 weeks from enrollment and 5 minutes post placement of each AFO]

Maximum ankle dorsiflexion in stance [6 weeks from enrollment and 5 minutes post placement of each AFO]

Maximum hip flexion in swing[6 weeks from enrollment and 5 minutes post placement of each AFO]

Cadence measure by 3D gait analysis[6 weeks from enrollment and 5 minutes post placement of each AFO]

Maximum ankle power at push-off[6 weeks from enrollment and 5 minutes post placement of each AFO]

Maximum knee flexor moment in single-support[6 weeks from enrollment and 5 minutes post placement of each AFO]

Hip rotation in at 25%[6 weeks from enrollment and 5 minutes post placement of each AFO]

Maximum knee flexion in swing[6 weeks from enrollment and 5 minutes post placement of each AFO]

Patient satisfaction measured using a child version of the Client Satisfaction with Device module of the Orthotics and Prosthetic Users’ Survey
[6 weeks from enrollment and 30 minutes post placement of each AFO]

Maximum ankle dorsiflexion in the last 1/3rd swing[6 weeks from enrollment and 5 minutes post placement of each AFO]

Thigh-foot angle at 25%[6 weeks from enrollment and 5 minutes post placement of each AFO]

Maximum knee extensor moment in stance[6 weeks from enrollment and 5 minutes post placement of each AFO]

Ankle gait variable score measured by 3D gait analysis[6 weeks from enrollment and 5 minutes post placement of each AFO]

Foot progression angle at 25%[6 weeks from enrollment and 5 minutes post placement of each AFO]

Hip flexion range of motion during swing (max in swing - initial contact)[6 weeks from enrollment and 5 minutes post placement of each AFO]

Mean sagittal plane knee moment in stance[6 weeks from enrollment and 5 minutes post placement of each AFO]

Stride length measured by 3D gait analysis[6 weeks from enrollment and 5 minutes post placement of each AFO]

Walking speed measured by 3D gait analysis

[6 weeks from enrollment and 5 minutes post placement of each AFO]

Maximum ankle dorsiflexion in swing[6 weeks from enrollment and 5 minutes post placement of each AFO]

Maximum hip adduction in stance[6 weeks from enrollment and 5 minutes post placement of each AFO]

Maximum hip adduction in swing[6 weeks from enrollment and 5 minutes post placement of each AFO]

Minimum hip flexion[6 weeks from enrollment and 5 minutes post placement of each AFO]

Plantar pressure measured using inshoe pedobarograpahy [6 weeks from enrollment and 5 minutes post placement of each AFO]

Timing of maximum ankle dorsiflexion in stance as a percentage of the gait cycle [6 weeks from enrollment and 5 minutes post placement of each AFO]

Maximum ankle plantarflexion at push-off[6 weeks from enrollment and 5 minutes post placement of each AFO]

Maximum pelvic obliquity in swing[6 weeks from enrollment and 5 minutes post placement of each AFO]

Maximum pelvic tilt[6 weeks from enrollment and 5 minutes post placement of each AFO]

Pelvic rotation at 25%[6 weeks from enrollment and 5 minutes post placement of each AFO]

Secondary ID(s)

Nil known

Source(s) of Monetary Support

Charcot-Marie-Tooth Association of Australia

Department of Education and Training

University of Sydney

Ethics review

Status: Approved
Approval date: 04/06/2018
Contact:

Sydney Childrens Hospitals Network Human Research Ethics Committee

Results

• Results available: Yes
• Date Posted: 16/07/2021
• Date Completed: 28/07/2019