Clinical Evaluation of Novel Custom 3D-Printed Meshed-Silicone Orthotics Utilizing Standing Foot Scans and Dynamic Gait Data
Background:Conventional orthotic insoles demonstrate limited accommodation for individual foot morphology and plantar pressure distribution patterns, resulting in biomechanical inefficiencies and patient discomfort. Computational approaches integrating artificial intelligence with additive manufacturing technologies offer promising solutions for personalized orthotic design. This study investigates the clinical efficacy of AI-driven 3D-printed meshed-silicone orthotics through comprehensive biomechanical assessment.Methods:A prospective cohort study (n = 21; 8 females, 13 males; age 25.6 ± 3.68 years; BMI 25.48 ± 3.46) evaluated custom orthotics fabricated using machine learning algorithms applied to individual foot and gait data. Pre- and post-intervention assessments included Visual Analog Scale (VAS), Foot Function Index (FFI), Foot Posture Index (FPI), plantar pressure distribution analysis, and 3-dimensional gait analysis over a 4-week period.Results:FFI scores showed minimal variation (pre-intervention: 13.48 ± 13.14; post-intervention: 14.10 ± 12.96). Significant biomechanical modifications were observed: multi-planar lower extremity alignment correction at hip, knee, and ankle joints. Plantar pressure redistribution demonstrated decreased heel loading with unchanged forefoot pressure distribution, accompanied by significant maximum metatarsal pressure elevation (P < .05).Conclusions:II. AI-integrated 3D-printed meshed-silicone orthotics demonstrated measurable biomechanical improvements including lower extremity alignment optimization and plantar pressure redistribution. These computational design methodologies combined with advanced manufacturing technologies establish a foundation for personalized orthotic interventions in clinical biomechanics applications.
- Research Article
54
- 10.5535/arm.2015.39.1.10
- Feb 1, 2015
- Annals of Rehabilitation Medicine
ObjectiveTo investigate the correlation between the Foot Posture Index (FPI) (including talar head palpation, curvature at the lateral malleoli, inversion/eversion of the calcaneus, talonavicular bulging, congruence of the medical longitudinal arch, and abduction/adduction of the forefoot on the rare foot), plantar pressure distribution, and pediatric flatfoot radiographic findings.MethodsNineteen children with flatfoot (age, 9.32±2.67 years) were included as the study group. Eight segments of plantar pressure were measured with the GaitView platform pressure pad and the FPI was measured in children. The four angles were measured on foot radiographs. We analyzed the correlation between the FPI, plantar pressure characteristics, and the radiographic angles in children with flatfoot.ResultsThe ratio of hallux segment pressure and the second through fifth toe segment pressure was correlated with the FPI (r=0.385, p=0.017). The FPI was correlated with the lateral talo-first metatarsal angle (r=0.422, p=0.008) and calcaneal pitch (r=-0.411, p=0.01).ConclusionOur results show a correlation between the FPI and plantar pressure. The FPI and pediatric flatfoot radiography are useful tools to evaluate pediatric flatfoot.
- Abstract
- 10.1136/annrheumdis-2016-eular.4097
- Jun 1, 2016
- Annals of the Rheumatic Diseases
BackgroundDuring rheumatoid arthritis the structure of the foot as well as the plantar pressure surfaces are changing due to the disease. The examinations carried out with the help of machines...
- Research Article
45
- 10.1186/s13047-015-0101-x
- Jan 1, 2015
- Journal of Foot and Ankle Research
BackgroundSeveral studies have found positive correlation between flatfeet and increased body mass in children. One study, utilizing a differing method of foot posture assessment, found the inverse. The purpose of this study was to further explore the relationship between children’s foot posture and body mass, utilizing the foot posture index in a large study population, as opposed to the footprint based measures of most previous studies.MethodsData for both foot posture index (FPI) and body mass index (BMI) for healthy children were acquired from five previous studies. The amalgamated dataset comprised observations for both BMI and FPI-6 in 728 children aged from three to 15 years. Three FPI-6 scores levels defined the range of flatfeet detected: FPI-6 ≥ +6; FPI-6 ≥ +8; FPI-6 ≥ +10. BMI cut-points were used to define overweight for each age group.ResultsIn the study population of 728 children, flatfeet (FPI ≥ +6) were found in 290 (40 %) cases and non-flatfeet in 438 (60 %) cases. FPI ≥ +8 yielded flatfeet in 142 (20 %) cases and FPI ≥ +10 yielded flatfeet in 41 (5 %) cases. Whilst 272 (37 %) children were overweight, only 74 (10.1 %) of the overweight children had flatfeet (FPI ≥ +6), which diminished to 36 (4.9 %) at FPI ≥ +8, and 9 (1.2 %) at FPI ≥ +10.Significant and moderate correlation was found between BMI and age (r = 0.384, p < 0.01). Very weak, but significant, correlation was found between BMI and FPI (r = −0.077, p < 0.05). Significant mean differences between gender and BMI were found (t-test = 2.56, p < 0.05). There was strong correlation between FPI scores on left and right sides (r = 0.899, p < 0.01).ConclusionsThis study found no association between increased body mass and flatfeet in children, a finding in contrast to that repeatedly concluded by many previous studies. Whilst properties of the FPI and BMI are limiting, these findings question the concern about children’s increased body mass as a specific influence on (flatter) foot posture, and also the validity of footprint versus anatomically based foot posture measures.
- Research Article
3
- 10.7547/22-047
- Mar 1, 2024
- Journal of the American Podiatric Medical Association
The effectiveness of different energy levels used in extracorporeal shockwave therapy (ESWT) has been investigated in previous studies, but controversy remains regarding which energy levels should be used in the treatment of plantar fasciitis. We compared the efficacy of different energy levels used in ESWT in the treatment of plantar fasciitis using plantar fascia thickness and pressure distribution. Between July 2021 and September 2021, a total of 51 patients (71 feet) with plantar fasciitis were randomized into three treatment groups using the sealed envelope method. Group 1 (n = 25) received low energy density (0.09 mJ/mm2), group 2 (n = 25) received medium energy density (0.18 mJ/mm2), and group 3 (n = 21) received high energy density (0.38 mJ/mm2). Each group received three sessions of ESWT at a frequency of 2,000 shocks per minute at 1-week intervals. Patients were evaluated before and after treatment using a visual analog scale (VAS) for pain, the Foot Function Index (FFI), plantar fascia thickness measured by ultrasonography, and plantar pressure distribution. Posttreatment VAS and FFI scores were determined to be significantly lower than the values before treatment in the three groups (P < .001). There were no significant differences among groups in pretreatment and posttreatment values of VAS, FFI, plantar fascia thickness, and pressure distribution (P > .05). No significant differences were found among groups in percentage changes in all of the outcome parameters (P > .05). There was no superiority among low, medium, or high levels of ESWT in terms of pain, foot functions, fascia thickness, and pressure distribution in the treatment of plantar fasciitis.
- Research Article
- 10.5606/tftrd.2022.4904
- Mar 1, 2022
- Turkish Journal of Physical Medicine and Rehabilitation
Objectives This study aims to compare ankle force, mobility, flexibility, and plantar pressure distribution of athletes according to foot posture index (FPI). Patients and methods Between September 2016 and May 2018, a total of 70 volunteer male athletes (mean age: 21.1±2.3 years; range, 18 to 25 years) were included. The athletes were divided into three groups according to their FPI as follows: having supinated feet (Group 1, n=16), neutral/normal feet (Group 2, n=36), or pronated feet (Group 3, n=18). Ankle range of motion (ROM), muscle flexibility, ankle joint strength, and plantar pressure distribution were measured. Results There were significant differences among the three groups in both right and left ankle dorsiflexion ROM (p=0.009 and p=0.003, respectively). Group 1 had significantly smaller dorsiflexion ROM than the other groups. Group 1 also showed significantly less flexibility in the gastrocnemius and soleus muscles than the other foot posture groups. Groups 2 and 3 exhibited significant differences in the maximum torque (p=0.018), maximum work (p=0.008), and total work (p=0.008) of the right plantar flexor muscles at 60°/sec angular velocity. Peak pressure measurements of the right foot were higher in Group 1, compared to Groups 2 and 3 (p<0.001). Conclusion The results of this study may help to enhance athletic performance by providing a guide for designing training programs appropriate for athletes with different foot types to address their specific muscle flexibility and strength deficiencies.
- Research Article
55
- 10.1016/j.gaitpost.2012.05.024
- Jun 21, 2012
- Gait & Posture
Can the Foot Posture Index or their individual criteria predict dynamic plantar pressures?
- Research Article
15
- 10.1123/jsr.2021-0091
- Feb 1, 2022
- Journal of Sport Rehabilitation
Running is a popular sport globally. Previous studies have used a gait retraining program to successfully lower impact loading, which has been associated with lower injury rates in recreational runners. However, there is an absence of studies on the effect of this training program on the plantar pressure distribution pattern during running. To investigate the short-term effect of a gait retraining strategy that uses visual biofeedback on the plantar pressure distribution pattern and foot posture in recreational runners. Randomized controlled trial. Biomechanics laboratory. Twenty-four recreational runners were evaluated (n = 12 gait retraining group and n = 12 control group). Those in the gait retraining group underwent a 2-week program (4 sessions/wk, 30min/session, and 8 sessions). The participants in the control group were also invited to the laboratory (8 times in 2wk), but no feedback on their running biomechanics was provided. The primary outcome measures were plantar pressure distribution and plantar arch index using a pressure platform. The secondary outcome measure was the foot posture index. The gait retraining program with visual biofeedback was effective in reducing medial and lateral rearfoot plantar pressure after intervention and when compared with the control group. In the static condition, the pressure peak and maximum force on the forefoot and midfoot were reduced, and arch index was increased after intervention. After static training intervention, the foot posture index showed a decrease in the foot pronation. A 2-week gait retraining program with visual biofeedback was effective in lowering rearfoot plantar pressure, favoring better support of the arch index in recreational runners. In addition, static training was effective in reducing foot pronation. Most importantly, these observations will help healthcare professionals understand the importance of a gait retraining program with visual biofeedback to improve plantar loading and pronation during rehabilitation.
- Research Article
4
- 10.1002/jfa2.12028
- May 31, 2024
- Journal of foot and ankle research
The aim of this study was to compare the plantar pressure distribution and knee and ankle muscle architecture in women with and without knee osteoarthritis (OA). Fifty women with knee OA (mean age=52.11±4.96years, mean Body mass index (BMI)=30.94±4.23kg/m2) and 50 healthy women as a control group (mean age=50.93±3.78years, mean BMI=29.06±4.82kg/m2) were included in the study. Ultrasonography was used to evaluate knee and ankle muscles architecture and femoral cartilage thickness. The plantar pressure distribution was evaluated using the Digital Biometry Scanning System and Milleri software (DIASU, Italy). Static foot posture was evaluated using the Foot Posture Index (FPI), and pain severity was assessed using the Visual Analog Scale. The OA group exhibited lower muscle thickness in Rectus Femoris (RF) (p=0.003), Vastus Medialis (VM) (p=0.004), Vastus Lateralis (p=0.023), and Peroneus Longus (p=0.002), as well as lower Medial Gastrocnemius pennation angle (p=0.049) and higher Fat thickness (FT) in RF (p=0.033) and VM (p=0.037) compared to the control group. The OA group showed thinner femoral cartilage thickness (p=0.001) and higher pain severity (p=0.001) than the control groups. FPI scores were higher (p=0.001) in OA group compared to the control group. The plantar pressure distribution results indicated an increase in total surface (p=0.027), total load (p=0.002), medial load (p=0.005), and lateral load (p=0.002) on dominant side in OA group compared to the control group. Knee and ankle muscle architecture, knee extensor muscle FT, and plantar pressure distribution in the dominant foot differed in individuals with knee OA compared to the control group.
- Abstract
- 10.1136/annrheumdis-2023-eular.3184
- May 30, 2023
- Annals of the Rheumatic Diseases
BackgroundSystemic lupus erythematosus (SLE) is a chronic autoimmune disease mediated by autoantibodies, with involvement of various organs[1,2]. El 95% of patients with SLE have musculoskeletal involvement[1], most often in the...
- Research Article
9
- 10.3390/healthcare11060785
- Mar 7, 2023
- Healthcare
Background: Pronated foot is a deformity with various degrees of physical impact. Patients with a pronated foot experience issues such as foot pain, ankle pain, heel pain, shin splints, impaired balance, plantar fasciitis, etc. Objective: The study intended to compare the effectiveness of IASTM (instrument-assisted soft tissue mobilization) and static stretching on ankle flexibility, foot posture, foot function, and balance in patients with a flexible pronated foot. Methods: Seventy-two participants between the ages of 18–25 years with a flexible pronated foot were included and allocated into three groups: Control, stretching, and IASTM group using single-blinded randomization. Range of motion (ROM) measuring ankle flexibility, foot posture index (FPI), foot function index (FFI), and dynamic balance was measured at baseline and after 4 weeks of intervention. Soft tissue mobilization was applied on to the IASTM group, while the stretching group was directed in static stretching of the gastrocnemius-soleus complex, tibialis anterior, and Achilles tendon in addition to the foot exercises. The control group received only foot exercises for 4 weeks. Results: The result shows the significant improvement of the right dominant foot in ROM plantar flexion, (F = 3.94, p = 0.03), dorsiflexion (F = 3.15, p = 0.05), inversion (F = 8.54, p = 0.001) and eversion (F = 5.93, p = 0.005), FFI (control vs. IASTM, mean difference (MD) = 5.9, p < 0.001), FPI (right foot, control vs. IASTM MD = 0.88, p = 0.004), and in dynamic balance of the right-leg stance (anterior, pre vs. post = 88.55 ± 2.28 vs. 94.65 ± 2.28; anteromedial, pre vs. post = 80.65 ± 2.3 vs. 85.55 ± 2.93; posterior, pre vs. post = 83 ± 3.52 vs. 87 ± 2.99 and lateral, pre vs. post = 73.2 ± 5.02 vs. 78.05 ± 4.29) in the IASTM group. The FFI was increased remarkably in the stretching group as compared to the control group. Conclusions: Myofascial release technique, i.e., IASTM with foot exercises, significantly improves flexibility, foot posture, foot function, and dynamic balance as compared to stretching, making it a choice of treatment for patients with a flexible pronated foot.
- Research Article
1
- 10.4103/pjiap.pjiap_10_20
- Jan 1, 2021
- Physiotherapy - The Journal of Indian Association of Physiotherapists
BACKGROUND: Foot postures are integral to the biomechanical alignment and the dynamic function of the lower extremity. This study compared foot postures in people with primary medial compartment osteoarthritis (OA) and age-, gender-, and body mass index (BMI)-matched controls using various foot measures. Grade-wise variations were also assessed. AIM: The aim of the study was to assess the foot postures in people with primary medial compartment knee OA. METHODS: This was an observational, analytical study and the subjects were recruited by convenient sampling from tertiary hospitals in Pune. The target population were primary knee OA who were clinically and radiologically diagnosed for their severity based on the Kellgren–Lawrence grading, a severity classification based on radiographic evidence. The Centre of Rheumatic Diseases version of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Foot Function Index (FFI) which are both self-report questionnaires were duly filled by the knee OA subjects for the pain and dysfunction of the knee and foot, respectively. The control group consisted of age-, gender-, and BMI-matched asymptomatic healthy subjects. Foot postures of all subjects namely, the OA (n=48) and controls (n = 33) were assessed using the foot posture index (FPI), arch index, and navicular drop test. The FPI as well as the navicular drop test categorized the subjects into 3 groups: pronated, neutral, and supinated. The arch index was calculated from the inked imprint of the foot of the affected limb where higher values indicated dropped arch. STATISTICAL ANALYSIS AND RESULTS: Independent samples Mann–Whitney U-test and unpaired t-test were used to investigate the differences between the two groups in the foot characteristics. The Spearman's rho was used to analyze the correlation of FPI with the grades of OA and of WOMAC with the FFI within the OA group. The study included 48 medial knee OA subjects (48 knees and the corresponding foot) and 33 age-, gender-, and BMI-matched healthy controls. The percentages of foot postures (neutral, pronated and highly pronated) of both groups were 71%, 25% and 4% respectively in the OA group and 92%, 2% and 6% respectively in the control group. Comparative study of foot postures between the two groups showed more pronated feet in the OA group (P < 0.001). Correlation of the FPI scores with the grades of OA showed no association (β = −0.005; P = 0.97) and between WOMAC and the FFI in the knee OA group showed weak association. (β = 0.0349; P < 0.05). CONCLUSION: The foot postures were altered in the knee OA group as compared to healthy controls, with the OA group showing more pronated foot type.
- Research Article
9
- 10.7547/16-021
- May 1, 2018
- Journal of the American Podiatric Medical Association
Elevated dynamic plantar pressures are a consistent finding in diabetic patients with peripheral neuropathy, with implications for plantar foot ulceration. This study aimed to investigate whether a first-ray amputation affects plantar pressures and plantar pressure distribution patterns in individuals living with diabetes and peripheral neuropathy. A nonexperimental matched-subject design was conducted. Twenty patients living with diabetes and peripheral neuropathy were recruited. Group 1 (n = 10) had a first-ray amputation and group 2 (n = 10) had an intact foot with no history of ulceration. Plantar foot pressures and pressure-time integrals were measured under the second to fourth metatarsophalangeal joints, fifth metatarsophalangeal joint, and heel using a pressure platform. Peak plantar pressures under the second to fourth metatarsophalangeal joints were significantly higher in participants with a first-ray amputation ( P = .008). However, differences under the fifth metatarsophalangeal joint ( P = .734) and heel ( P = .273) were nonsignificant. Pressure-time integrals were significantly higher under the second to fourth metatarsophalangeal joints in participants with a first-ray amputation ( P = .016) and in the heel in the control group ( P = .046). Plantar pressures and pressure-time integrals seem to be significantly higher in patients with diabetic peripheral neuropathy and a first-ray amputation compared with those with diabetic neuropathy and an intact foot. Routine plantar pressure screening, orthotic prescription, and education should be recommended in patients with a first-ray amputation.
- Research Article
7
- 10.1093/milmed/usaa032
- Mar 16, 2020
- Military Medicine
Soldiers' lower limbs and feet are frequently affected by overload- and overuse-related injuries. In order to prevent or limit the incidence of these injuries, the use of foot orthoses is often recommended. The aim of this study is to assess the effects of shock-absorbing insoles on in-shoe plantar pressure magnitude and distribution in a group of professional infantry soldiers wearing military boots during standard indoor military training. Twenty male professional soldiers of the Italian Army (age 35.1±6.1years; BMI 25.2±2.3kg/m2) were recruited for this study. Each subject underwent clinical examination to assess possible overuse-related diseases of the lower limb and trunk. Subjects with altered foot morphology according to the Foot Posture Index (FPI) were excluded from this study. Twelve subjects were considered eligible and therefore underwent an indoor training routine comprised of marching, running, jumping inside parallel bars and jumping from different heights. Soldiers repeated the training session twice wearing standard military boots along with two types of insoles: the standard prefabricated insole within the boots (STI), and a special shock-absorbing insole (SAI) featuring an elastic medial arch support. A 99-capacitive sensor insole system was used to record plantar pressure distribution in both feet. Analysis of in-shoe pressure parameters at rearfoot, midfoot and forefoot and in the total foot was performed via a custom-software application developed in MATLAB. Perceived foot comfort (VAS 0-15) was also assessed. Pressure parameters recorded during walking and running were considered suitable for statistical analysis. In the whole foot region, pressure parameters were 18-22% lower in military boots fitted with the SAI during walking and 14-18% lower during running. SAI resulted in better comfort (+25%) with respect to the prefabricated boot orthotics (median comfort: SAI=15/15; STI=12/15; p=0.0039) both during walking and running. Shock-absorbing insoles can be an effective solution when fitted inside military boots. The present functional evaluation shows that wearing a prefabricated shock-absorbing insole can provide a significant amelioration of perceived foot comfort and plantar pressure parameters. Further studies are now needed with a larger population and more demanding exercises.
- Research Article
31
- 10.1016/j.gaitpost.2019.08.023
- Sep 5, 2019
- Gait & Posture
The insole materials influence the plantar pressure distributions in diabetic foot with neuropathy during different walking activities
- Research Article
7
- 10.5152/eurjrheum.2016.053
- Sep 3, 2019
- European Journal of Rheumatology
Foot problems are often present in Systemic Sclerosis (SSc) patients, however studies regarding podiatric problems related to SSc are lacking and there are no data evaluating the foot biomechanical changes. The aim of the present pilot study was to evaluate podiatric problems in an Italian cohort of SSc patients by assessing received podiatric services, foot pain and disability and biomechanical foot deformity. 25 consecutive SSc patients were enrolled from the Division of Rheumatology, University of Florence. All SSc patients were assessed by: Standards of Care for People with Foot Musculoskeletal Health problems: Audit Tool, Foot Function Index (FFI), Weight and non-weight bearing foot joint assessment, (Foot Posture Index (FPI) and Gait Cycle), Health Assessment Questionnaire (HAQ) and Medical Outcomes Survey Short Form 36 (SF-36). Audit Tool - Only 7 (28%) out of the 25 patients with SSc had a specific podiatric assessment and treatment: no patient received a foot health assessment within the first 6 months of disease diagnosis and no patient received information about foot involvement. 1 patient (4%) received foot assessment every year; 1 patient (4%) received specific information about the disease and 5 patients (20%) received information about the benefits of using adapted footwear and insoles. FFI - Values of pain, disability and activity limitations, reported in FFI, are 4.7±5.1, 5.1±3.2 and 3.2±3.1 (M±DS), respectively. Non-weight bearing foot joint assessment shows a rearfoot varus deformity in 64% of patients, forefoot varus deformity in 42% and 6% forefoot valgus deformity. Weight bearing foot joint assessment, through FPI shows a pronated foot 20% of patients with and 34% with highly pronated overall foot posture. Gait analysis shows that 64% of patients has a contact of the calcaneus in invertion while 36% in eversion. In the midstance, 78% have the foot in pronation and 22% in supination, while in propulsion 12% presents a takeoff of the foot in supination and 88% in the pronation. HAQ result is 1.13±0.80, SFI and SMI scales of SF-36 have scores of 32.38±10.65 and 38.67±11.40, respectively. Our results shows that podiatric problems in SSc patients are common, serious but foot assessment and health care are inadequate. Thus, foot health information should be improved in order to better empower patients to self-manage low risk problems and help identify high-risk problems, which require specialist care.
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