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Table 1 Participant characteristics, 3D printed orthotic details and outcomes of includes studies

From: Feasibility of designing, manufacturing and delivering 3D printed ankle-foot orthoses: a systematic review

Reference AACPDM level of evidence & conduct rating Participants’ Characteristics Orthotic Details Outcomes and Results
Study Design N Condition Intervention vs control condition 3D printing method and material Outcomes Main Results and Authors conclusions OCEBM level
Aydin et al., 2018 [20] V (1/7) Computing analysis and prototyping 1 Healthy participant Customised FDM AFO vs no control FDM
ABS
FEA: Material displacement Material displacement of the AFO model using mechanical properties from 3D tested specimens was higher compared to the using mechanical properties from supplied with the FEA software. 5
Deckers et al., 2018 [21] V (1/7) Case-studies 7 Trauma, neuro-muscular disorder and cerebral palsy
(3 children, 4 adults)
Customised SLS AFO with a 3 mm thick calf and foot section connected with 2 carbon fibre rods (6 weeks) vs traditionally manufactured AFOs (6 weeks) SLS
Polyamide 12 (PA12)
Observation after 6-week trial No noticeable failure or wear with the traditionally manufactured AFOs after 6 weeks. 5/7 SLS AFO broke during the 6-week period, 1 SLS AFO showed signs of cracking and 1 did not fail. 4
Cha et al., 2017 [22] V (1/7) Case study 1 Right side foot drop after embolectomy (female, 68 yrs) Novel customised SLS AFO vs traditional polypropylene AFO (altered wear over 2 months) FDM
Polyurethane
Durability test of 300,000 cycles
QUEST after 2 months
3DGA: temporal spatial parameters, ankle kinematics
No crack, shape or stiffness change following the durability test. The participant was more satisfied with 3D printed AFO in terms of weight and ease of use. Temporal spatial parameters were similar between AFOs however ankle dorsiflexion in swing was less with the 3D printed AFO compared to the traditional AFO. 4
Choi et al., 2017 [23] IV (3/7) Case-studies 8 Healthy participants (4 male, 4 female 25.3 SD 4.5 yrs) Customised articulated FDM AFO with a metal hinged joint and 2 elastic polymer bands at 4 levels of stiffness and no resistance vs no control FDM
PLA
3DGA: kinematics
Ultrasound
Musculoskeletal modelling
Increasing AFO stiffness increased peak ankle dorsiflexion moment and decreased peak knee extension and peak ankle dorsiflexion. The method may assist AFO design and prescription to improve gait. 4
Creylman, et al., 2013 [13] IV (3/7) Case-control 8 Unilateral drop foot due to dorsiflexor weakness from multiple conditions
(male 46.6 yrs. SD 12.5)
Customised SLS AFO vs traditionally manufactured polypropylene AFO vs barefoot SLS
Nylon 12 (PA 2201)
3DGA: temporal spatial parameters and kinematics. No statistically significant differences between the traditionally manufactured AFO and of SLS AFO in terms of temporal spatial gait parameters, ankle angle at initial contact and maximum ankle plantarflexion during swing. Significant differences were noted in ankle range of motion. Authors attribute this to differences in material stiffness. 4
Faustini, et al., 2008 [14] V (1/7) Case-study 1 Post-Polio Syndrome (male 66 yrs) SLS PD-AFO vs Dynamic Brace CF-AFO SLS
Nylon 11 (Rilsan D80), Nylon 12 (DuraForm PA) and glass-filled Nylon 12 (DuraForm GF)
Rotational stiffness, energy dissipation & destructive testing. Nylon 11 exhibited the least amount of mechanical damping and was the only material to withstand the destructive testing 4
Mavroidis, et al., 2011 [15] V (2/7) Case-study 1 Healthy participant Customised SLA AFO (rigid & flexible) vs prefabricated injection moulded polypropylene AFO vs shod only SLA
Accura 40 resin and DSM Somos 9120 Epoxy
Photopolymer
3DGA: temporal spatial parameters, kinematics and kinetics.
Patient perceived fit.
3D printed AFOs provided good fit to the participant’s anatomy and were comparably to the prefabricated AFO during gait 4
Schrank and Stanhope., 2011 [16] V (0/7)
Case-studies
2 Healthy participants (male 48 yrs.; female 21 yrs) 4 half scale PD-AFO and two full-scale PD-AFO vs no control SLS
Nylon (DuraForm EX Natural Plastic)
Dimensional accuracy.
Patient perceived fit.
Dimension discrepancies were well under a 2 mm tolerance for the four half-scale orthoses. Subjective evaluations of the full-scale PD-AFOs following use in gait were positive 4
Schrank, et al., 2013 [15] V (0/7) Case-studies 2 Healthy participants (male 25 yrs.; female 24 yrs) 2 sets of stiffness tuned PD-AFOs vs no control FDM
medical-grade polycarbonate (PC-ISO).
Dimensional accuracy, manufacturing precision and bending stiffness prediction accuracy. The virtual functional prototyping had excellent dimensional accuracy, good manufacturing precision and strong predication accuracy with the derived modulus 4
Telfer, et al., 2012 [18] V (1/7) Case-study 1 Healthy participant (male 29 yrs) Customised SLS AFO at two different stiffness levels vs shod only SLS
Nylon-12 (PA2200)
3DGA: kinematics and kinetics The AFO had distinct effects on ankle kinematics which could be varied by adjusting the stiffness level of the device 4
Walburn, et al., 2016 [19] V (0/7)
Prototyping
0 None A novel segmented 3D printed and CFRP AFO vs no control FDM
ABS
Linear stiffness coefficient A novel segmented 3D printed and CFRP AFO has been proposed. 5
  1. AACPDM American Academy for Cerebral Palsy and Developmental Medicine, OCEBM Oxford Centre for Evidence-Based Medicine Levels of Evidence, AFO Ankle-foot orthoses, PD-AFO Passive-dynamic ankle foot orthoses, CFRP carbon fibre reinforce spring, SLS Selective laser sintering, SLA Stereolithography, FDM Fused deposition modelling, 3DGA Three-dimensional gait analysis, FEA Finite element analysis, QUEST Quebec User Evaluation of Satisfaction with Assistive Technology