None listed
Conditions
Brief summary
The aim of this project is to evaluate 3D printed AFOs compared to traditional handmade AFOs in children and adolescents with Charcot-Marie-Tooth disease (CMT) during walking. Three AFO designs will be evaluated traditional AFO, replicated 3D printed AFO and optimised 3D printed AFO and compared to a shoe only condition. Traditional AFOs will be handmade by an Orthotist from plaster casting methods of the participant’s 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 the state of the art 3D printer. 3D gait analysis and inshoe plantar pressure data will be collected to assess differences in walking.
Interventions
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 usi
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.
Sponsors
Professor Joshua Burns
Study design
Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
5 Years to 16 Years
Healthy volunteers
No
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.
Outcome results
None listed