Custom-made Insoles Research Articles

Effects of insoles adapted in flip-flop sandals in patients with persistent plantar heel pain: A sham-controlled randomised trial.

To evaluate the use of custom-made insoles adapted to flip-flops on pain intensity, foot function, and functional walking ability in individuals with persistent plantar heel pain in the short and medium term. Randomised controlled trial. Flip-flop sandals in patients with persistent plantar heel pain. Participants (n = 80) were assessed at baseline, six and 12 weeks after the intervention, and 4 weeks post-intervention. For the primary outcomes, after 6 weeks of intervention, no between-group difference was observed in the intensity of morning pain or pain with walking, mean difference = -0.4 (95% confidence intervals = -1.5 to 0.8). Similarly, after 12 weeks of intervention, no between-group difference was observed in the intensity of morning pain or pain with walking, mean difference = -0.7 (95% confidence intervals = -1.9 to 0.6). Finally, at 4 weeks after the end of the intervention, there was no between-group difference in morning pain or pain on walking, mean difference = 0.01 (95% confidence intervals = -1.4 to 1.4). All differences and confidence intervals were smaller than the minimum clinically important difference for pain (2 points). There were no differences between the groups for the secondary outcomes. In addition, the mean differences were smaller than the minimum clinically important differences for pain intensity, foot function and functional walking ability. Custom-made insoles fitted to flip-flops did not differ from flip-flops with sham insoles in improving pain intensity, foot function and functional walking ability in people with persistent heel pain.Trial registration: ClinicalTrials.gov (Identifier: NCT04784598). Data of registration: 2023-01-20.

Comparative study of the effects of custom-made insole and ordinary insole in adults with flexible flatfoot on different slopes.

Flatfoot (pes planus) is a common foot deformity, and its causes are mainly related to age, gender, weight, and genetics. Previous studies have shown that custom-made insoles could have a positive effect in improving plantar pressure and symptoms in individuals with flexible flatfeet, but it remains to be explored whether they can still show benefits in daily walking on different slopes. This study aims to investigate a custom-made insole based on plantar pressure redistribution and to verify its effectiveness by gait analysis on different slopes. We recruited 10 subjects and compared the peak pressure and impulse in each area between custom-made insole (CI) and ordinary insole (OI) groups. The results illustrate that CI raises the pressure in T area, improves the ability of the subjects to move forward in the slope walking, which was beneficial to gait stability. The redistribution of pressure in MF and MH area is promoted to provide active protection for subjects. Meanwhile, CI could decrease the impulse in MF area during uphill and level walking, which effectively reduces the accumulation of fatigue during gait. Moreover, avoiding downhill walking could be able to protect foot from injury in daily life.

Innovation of Custom-Made Silicone Insoles for Diabetic Patients

Diabetic foot ulcers, caused by diabetes-related nerve and blood vessel damage, can lead to amputations. Silicone insoles help prevent ulcers but are often expensive. Affordable, customized insoles are available, making prevention more accessible. This research aims to create affordable, locally manufactured silicone insoles for diabetic foot ulcers, reducing costs and improving accessibility. A six-month study at the Pakistan Rehabilitation Center assessed the quality of life in diabetic foot ulcer patients using the Foot Health Status Questionnaire (FHSQ). After four weeks of using silicone insoles, participants experienced significant improvements in foot health, pain relief, and mobility. They reported easier daily tasks and enhanced social interaction. Over four weeks, silicone insoles greatly improved foot health, reduced pain, and enhanced daily functioning and social interaction. The degree of improvement varied according to the initial severity of participants' conditions

Go Across Immersive Technology: A Preliminary Study of the Design and Development of a System for Gait Training Using Virtual Reality.

Virtual reality (VR) allows visuotactile interaction in a virtual environment. VR has several potential applications such as surgical training, phobia treatments, and gait rehabilitation. However, further interface development is required. Therefore, the objective of this study was to develop a noninvasive wearable device control to a VR gait training program. It consists of custom-made insoles with vibratory actuators, and plantar pressure sensor-based wireless interface with a VR game. System usability testing involved a habituation period and three gaming sessions. Significant gait improvement was associated with game scores (P < 0.05). This VR gait training system allowed real-time virtual immersive interaction with anticipatory stimulus and feedback during gait.

The Effect of Personalized Shoe Insoles on Parkinson’s Disease Subjects: A Triple-Blind Randomized Controlled Trial

Subjects with Parkinson’s Disease (PD) display different motor and non-motor symptoms. Different therapies have been shown to be effective, such as plantar foot stimulation, which has proved to be effective for motor symptoms. Different stimulation methods were proposed and tested through specific devices, or insoles. Our aim was to assess the effect of a newly designed custom-made insole called PRO-STEP compared with a flat sham insole on subjects with PD. Subjects were randomized 1:1 into two arms and were asked to wear PRO-STEP or sham insoles for at least 6 h per day for 10 weeks. Participants were evaluated at four timepoints. Forty-two subjects were randomly assigned to the PRO-STEP (EG) or sham group (SG). The comparison of the EG and SG without and with insoles (T0–T1) did not show significant differences in the TUG time and in the 10MWT gait parameters. At T1, T2, and T3 TUG time, BBS, SF12-MC, and SF12-PC did not show significant differences. The satisfaction level with the PRO-STEP or sham insoles was high in both groups. PD patients were satisfied with PRO-STEP insoles; however, plantar foot stimulation is not effective from a functional perspective. Future studies should consider possible modifications to the proposed stimulation to improve its effectiveness in patients with PD.

Biomechanical investigation of a custom-made insole to decrease plantar pain of children with flatfoot: A technical note

ObjectiveThe abnormal plantar pressure of flatfoot patients is a common condition. The main objective of the present study was to investigate the effect of custom-molded insole on the plantar pain of flatfoot Methods105 patients (representing 174 feet) participated in evaluating a custom-made orthotic insole from June 2018 to March 2019. The height of the navicular tubercle (HNT) and the deflection angle of calcaneus (DAC) in flatfoot patients after using orthotic insoles for 6 months were recorded by X-ray imaging and scanning measurements. Plantar pressure on metatarsals 1–5 was measured by using an RSscan system ResultsWithout the use of an orthotic insole, mean HNT was 0.99±0.34 cm and mean DAC was 20.0 ± 3.78 ° during the bearing weight. After using the insole, mean HNT and DAC values reduced to 0.87±0.30 cm and 14.3 ± 3.45 °, respectively (P < 0.05). Hindfoot plantar pressure did not change significantly (P > 0.05). Furthermore, pressure at metatarsals 1–3 decreased by 48.5 %, 45.6 %, and 14.3 %, respectively; that at metatarsals 4–5 increased by 33.3 % and 137.5 %, separately, when using the custom-made insole ConclusionsVisual analog scale score for plantar pain was significantly reduced. These findings indicate that metatarsal pain of flatfoot patients might be the cause of load imbalance in plantar foot.

Sever’s Disease – a common cause of heel pain among sport-active children

Objectives: Sever’s disease (Calcaneal Apophysitis) is the most common cause of heel pain in growing and active children and adolescents. Studies imply that the prevalence is increasing for children attending sports with repetitive running and jumping. These children are advised to pause their sport when heel pain occurs. However, activity modifications, immobilization, or absolute rest often has a negative impact and can lead to total drop-out. The objective of the study is to examine whether an intervention based on information and custom-made insoles can decrease pain levels in children between 6-14 years with Sever’s disease and make them return faster to sport activities instead of the conservative treatment with rest and/or activity modification. Methods: The study is a descriptive observational study based on a database from a physiotherapeutic clinical practice. This included 469 children between 6-14 years with diagnosed Sever’s disease who sought an expert in sports physiotherapy due to severe pain and limited sport activity. Baseline information was collected by the physiotherapist. Parents filled a questionnaire as follow up 3 months after the intervention. Results: The children experienced pain for 10,4 months on average. They all reported that their sport activities had been reduced or stopped entirely due to heel pain. All children received an intervention which included information about Sever’s disease and the physiology of the foot, combined with a customized insole that suspend the heel to relieve pressure on the apophysis of the calcaneus. The intervention helped most of the children to resume their sport activity. Conclusion: Sever’s disease is a painful, discomforting condition which causes reduced activity level in sport-active children and even ceasing sports completely, but customized insoles can ease pain and avert or limit immobilization.

Customized Design for Ergonomic Products via Additive Manufacturing Considering Joint Biomechanics

This paper presents a customized design method for ergonomic products via additive manufacturing (AM) considering joint biomechanics. An ergonomic customized design model can be built based on kinesiology involving human joint biomechanics. Manifolds of the human bone can be reconstructed from X-rays, computed tomography (CT), magnetic resonance imaging (MRI), and direct 3D scanning. The conceptual and detailed design of customized products were implemented on ergonomic shoes and insoles. A lightweight lattice structure with variable porosity was generated via structural topology optimization for an ergonomic customized design. Notably, the upper surface of the custom-made insole may adhere perfectly to the plantar surface of the patient, resulting in a lower peak plantar pressure. Finite element analysis (FEA) can be employed to simulate the static or dynamic biomechanical characteristics. The conceptual ergonomic products were forwarded to the machine and fabricated via AM, driven by visual digital twin techniques. The experiments proved that a customized design suitability method for wearable ergonomic products via 3D printing is specifically tailored to the rehabilitation needs of individual customers, while consuming the least cost, time, and materials.

Comparison between Total Contact Custom-Made Insole versus Over the Counter Insole in Rehabilitation of Rheumatoid Arthritis Patients

Objective To compare the effect of total contact custom-made foot insoles versus over-thecounter flat silicone insoles on pain and foot function in rheumatoid arthritis patients. Patients and Methods This study included 30 patients diagnosed with rheumatoid arthritis according to the 2010ACR/EULAR classification criteria. All underwent history, clinical examination of foot, plantar pressure assessment, pain assessment by visual analog scale (VAS), foot functionality, assessed by Lower Extremity Functional Scale (LEFS). Patients were randomly assigned to group (A) 15 patients which received total contact custom made insoles. And group B, 15 patients received a flat over the counter insole made of silicone, follow up was done after two weeks using VAS and LEFS scores. Results A total of 30 patients, aged 46.07 ± 10.78 years, with disease duration ranged from 2 – 18 years with Median (IQR) of 5.50, body mass index (BMI) ranged from 19.5 to 37 kg/m2 with mean ±SD of 29.01 ± 4.00. In both groups, significant difference in the VAS after using insoles, observed more in -group A with mean ± SD 22.67 ± 11.47, while mean ± SD of group B was 39.00 ± 14.04. Regarding LEFS score: significant improvement of the score ―improved lower limb functionality‖ in both groups after using the insoles, slightly higher in group B more than group A. No significant differences in functionality between the two groups (LEFS score after intervention for group A with Mean ± SD 40.13 ± 9.88, group B with Mean ± SD 43.20 ± 6.82). Conclusion The custom-made foot orthoses significantly reduced the patients’ foot pain, although they did not have significantly positive effects on disability and foot functionality compared with only cushioning.

Effect of Custom-Made Orthotic Insoles on Lower Limb Biomechanics in Children with Flexible Flat Feet

This study aimed to investigate the effect of custom-made orthotic insoles on the lower limb biomechanics in children with flexible flat feet. A sample of 27 children (19 boys and eight girls) aged 7 to 13 years old with flexible flat feet participated in the study. Each custom-made orthotic insole was individually designed based on the foot of each subject, using ethylene-vinyl acetate (EVA) material with medium density. The study was conducted using a gait analysis laboratory, and participants were required to walk randomly at a self-selected speed with one of three insole conditions (custom-made orthotic insole, flat insole, and barefoot). The data was processed using Visual 3D software and analyzed by SPSS software. The results showed that using custom-made orthotic insoles resulted in a significant reduction in the maximum ankle inversion angle and ankle inversion moment while increasing the knee adduction moment during the stance phase when compared to wearing either flat insoles or being barefoot (p&lt;0.05). This study found that custom-made orthotic insoles significantly altered the biomechanical characteristics of the lower limbs of children with flexible flat feet, reducing the movement of the ankle joint in the frontal plane, thereby enhancing ankle joint stability, but may increase knee joint load.

Effect of Custom-designed Insole with Arch and Metatarsal Support on Adjustment of the Lower Limb Kinematics

Insole construction is considered to be related to stability in sports, and custom-made insoles with their scientifically tailored approach and effective construction are considered to be the main means of adjusting posture and reducing risk in sports. We have designed a non-100% full-fit design insole (CDI) with an arch support insole and metatarsal liner to determine whether this insole can be adapted to lower limb kinematics. Eleven healthy volunteers participated in this randomized crossover test in which a motion capture and 3D gait analysis system was used to measure the subjects’ lower limb kinematic data while exercising at different slopes and speeds wearing three different insoles: CDI, control Insole (CI) and arch support insoles (ASI). In addition, the experiments introduced the speed and slope factor, analyzed the extent to which speed slope affects joint angle using UNIANOVA, and compared the performance differences between the three insoles in different planes in pairs. The CDI inhibited ankle dorsiflexion and knee flexion in the sagittal plane; in the frontal plane, CDI reduced knee adduction and hip abduction angles. There was a statistically significant difference (p &lt; 0.05) between the change in joint angle and the velocity slope. Slope*speed had a greater effect on the ankle and knee joints (%sig&gt;30%). The results show that the CDI has better kinematic adjustability in the ankle and knee joints due to its superior insole design approach. Therefore, wearing the CDI may be an effective way of reducing risks in sports.

Custom-Made Ethyl Vinyl Acetate Insoles with Arch Support Could Improve Static Balance in Diabetic Women with Neuropathic Foot.

Individuals with diabetic neuropathy may experience plantar ulcers and postural instability. Although use of an insole with arch support has the potential to decrease the incidence of plantar ulcers, the choice of proper design and material density concerning postural stability is challenging. The objective of this pilot study was to conduct a preliminary evaluation of the immediate effects of custom-made ethyl vinyl acetate insoles with arch support and Shore A values of 30 or 50 on static balance in patients with diabetes and neuropathic foot/feet. Ten women with diabetes participated in this study. Static balance was analyzed while in double-limb standing with eyes closed and eyes open and while standing on a dominant limb with eyes open wearing shoes only and wearing shoes and insoles with Shore A values of 30 and 50. With insole, the mean values of center of pressure excursions decreased significantly while standing on double limbs with eyes closed. The improvement in static balance was greater while using the insole with greater density; however, the difference was not statistically significant. An insole with arch support made of ethyl vinyl acetate Shore A of 30 and 50, which could decrease plantar pressure concentration, had no negative effect on the static balance of diabetes. Therefore, further research on the long-term effects of such insoles on the static balance of diabetes is suggested.

Comparing the effects of University of California Biomechanics Laboratory and custom-made semi-rigid insole on pedobarographic parameters in pediatric flexible flat foot.

Pediatric flexible flat foot (PFFF) is often associated with pain along the medial longitudinal arch and potential disability. There are several conservative treatment options for PFFF, ranging from intrinsic muscle exercises to orthosis, including University of California Biomechanics Laboratory (UCBL) and custom-made semi-rigid insoles. To investigate and compare the effect of UCBL and custom-made semi-rigid insoles on pedobarographic and radiologic parameters in PFFF. This study prepared a retrospective chart review of 143 children diagnosed with PFFF between the age of 4 and 12 years. Data of twenty-seven children with PFFF who were prescribed foot orthoses between the age of 4 and 12 years were retrospectively reviewed. Medical charts were retrospectively reviewed, and pedobarographic and radiological parameters assessed before and 1 year after application of orthoses were reviewed. The difference in the calcaneal pitch angle and the center of pressure excursion index (CPEI) were significantly improved in the custom-made semi-rigid insole group compared to that in the UCBL group. The contact area ratio of the midfoot and toe and CPEI at 1 year after wearing the insole was significantly improved in the custom-made semi-rigid insole group compared to that in the UCBL group. Moreover, the calcaneal pitch angle and CPEI were significantly improved 1 year after application of the insole in the custom-made semi-rigid insole group. This result showed that the custom-made semi-rigid insole is more effective in improving the deviation of the center pressure curve and calcaneal pitch angle than the UCBL. The custom-made semi-rigid insole may help relieve foot instability during gait and improve the medial longitudinal arch in children with PFFF.

The dynamic characteristics of the center of pressure for toe-out gait: implications for footwear design

BackgroundToe-out gait is often used as a conservative technique to reduce knee adduction moment, which has been targeted to modify knee osteoarthritis progression. The center of pressure (COP) can not only be used to evaluate gait stability, but is also more reliable and practical than local plantar pressures as it does not depend on accurate foot zone divisions. However, to the authors’ knowledge, few study has reported the influence of the foot progression angle on the dynamic characteristics of the COP.Research questionThe aim of the study was to investigate the effects of the deliberately toe-out gait on the COP trajectory and stability during walking in healthy individuals.MethodsThirty healthy young adults were asked to walk along an 8-m walkway. A Footscan 1 m pressure plate was used to measure the center of pressure during walking.ResultsCompared to the normal gait, the COP of the toe-out gait shifted laterally during the initial contact phase, and shifted laterally and anteriorly during the forefoot contact phase. The mean anterior–posterior velocity of COP reduced by 0.109 m/s during the foot flat phase and the duration of the foot flat phase and forefoot push off phase increased by 4.5% and reduced by 7.0%, respectively.SignificanceCompared to the normal gait, the findings of this study suggest that biomechanical alteration of foot under our experimental conditions may decrease gait stability and increase forefoot load during toe-out walking. The situation may be improved by well-designed footwear or custom-made insole and the biomechanics analysis method can be used to test the efficacy of therapeutic footwear or insole for individuals with deliberately toe-out walking.Graphical

Intensive physiotherapy versus home-based exercise and custom-made orthotic insoles in patients with plantar fasciitis: Pilot study

BackgroundThis prospective pilot study assessed the feasibility of comparing intensive physiotherapy group (IPG), home-based exercise (HBEG) group, and insole group (IG) to find the most effective treatment program for plantar fasciitis. MethodsThirty-nine individuals with plantar fasciitis were selected to participate in this pilot study. The patients were randomly divided into 3 groups, as IPG (manual interventions, exercise, insoles), HBEG (exercise, insoles), and IG (insoles). The feasibility details including percentage of the enrollment and adherence to the groups were recorded. Pain was measured with a visual analog scale, and dorsiflexion range of motion (DROM), foot function, and health-related quality of life were evaluated at the baseline and week 6. One-way ANOVA analysis and Kruskal Wallis test were used to determine the differences of the percentage change of the parameters. ResultsPain and functional evaluation results showed improvements clinically in all of groups and quality of life results were similar for all groups. There was no difference between the groups after 6 weeks of treatment (P > 0.05). ConclusionsThe 3 treatment programs were found clinically applicable with high patient adherence. According to the data all intervention types were found moderately effective for pain and function. Insoles could be an option applied alone or with other treatments, and manual techniques gave better results in patients with limited ankle dorsiflexion. Although the results should be interpreted with caution because of the small sample size, these results were found promising and feasible to conduct a future RCT. Clinical trial registration numberRCT 06144834.

Can we predict which patients with plantar heel pain are more likely to benefit from insoles? A secondary exploratory analysis of a randomized controlled trial

BackgroundPlantar heel pain (PHP) is a common cause of foot complaints, for which treatment with custom-made insoles is frequently applied. So far few studies have investigated patient characteristics that predict response to these treatments. The aim of this secondary exploratory analysis was twofold; firstly, to identify patient characteristics that predict prognosis in patients with PHP treated with insoles, and secondly to identify characteristics that might interact with treatment with insoles.MethodsData from a randomized trial in which participants received either custom insoles (N = 70) or sham insoles (N = 69) were used. At baseline, information was collected on demographics, foot symptoms, foot and ankle range of motion, navicular drop, presence of neuropathic pain, physical activity and other illnesses in the last 12 months. The primary outcome of this study was the Foot Function Index score (FFI) at 26 weeks. Multivariable linear regression models were generated to identify patients characteristics that predict the outcome for each type of intervention (i.e. insoles and GP-led usual care).ResultsWe found two variables associated with a better function score at 26 weeks in patients treated with insoles, female sex (β − 9.59 95%CI -17.87; − 1.31) and a lower FFI score at baseline (β 0.56 95%CI 0.30; 0.82). Explorative analyses in patients treated with insoles showed no significant interaction effects between the type of insole (custom-made versus sham) and any of the potential predictive factors.ConclusionWhen communicating about the effect of insoles for PHP clinicians should take sex and the amount of pain and disability at first presentation into account. Women and people with better foot function scores at baseline (according to FFI) might respond better to treatment with insoles in terms of foot function.Trial registrationTrial registration: NTR5346.

Effects of Custom-made Insoles on Plantar Biomechanics and Upper Extremity Muscle Performance.

To investigate the effectiveness of molding custom-made insoles for female patients with foot pain. The study included 20 patients whose insoles were prescribed according to biomechanical evaluations and molded by repositioning the subtalar joint in its neutral position using a simple set of tools. Plantar biomechanics were measured under the following conditions: static stand, walking at self-comfortable walking speed (CWS) barefoot, walking in patient owned running shoes, and walking in running shoes plus insoles. Each patient's upper arm isometric muscle strength and subjective feelings before and after the insole intervention were assessed. The molded insoles increased plantar contact area both during static standing and walking at CWS compared to the barefoot condition. The insoles also had more evenly distributed plantar contact area and loading rate, with the changes in the medial arch area being most significant. Moreover, the custom-made insole intervention immediately increased maximum resistance and duration of bilateral upper arms, as well as improved foot comfort, especially at the medial arch area during single leg squat tests. Molding custom-made insoles by repositioning the subtalar joint in its neutral position can be accomplished with a simple set of tools, making this method highly applicable for a majority of less developed regions. Insoles molded using this method are effective in immediately improving plantar biomechanics disorders and enhancing isometric upper muscle performance in female patients with foot pain.

Cost-effectiveness of custom-made insoles versus usual care in patients with plantar heel pain in primary care: cost-effectiveness analysis of a randomised controlled trial

ObjectivesTo evaluate the cost-effectiveness of custom-made insoles compared with general practitioner (GP)-led usual care after 26 weeks of follow-up in individuals with plantar heel pain (PHP) from a societal perspective.DesignCost-effectiveness...

Effects of custom-made insoles on foot pressure redistribution, gait parameters, and pain in calcaneal apophysitis-a pretest and posttest study.

Calcaneal apophysitis is a self-limiting disorder that often affects adolescents with a high level of activity and leads to increased pain severity, impairments in gait parameters, and poor health-related quality of life. To investigate the combination of custom-made insoles and exercise on foot pressure distribution, spatial-temporal gait parameters, and pain intensity in patients with calcaneal apophysitis. A one-group pretest-posttest design. Forty patients, aged between 8 and 15 years, diagnosed with calcaneal apophysitis, were included in this study. Patients were asked to use the custom-made insoles and to perform a home exercise program for 3 days a week. The duration of treatment was 4 weeks. The pain severity was evaluated with the Visual Analog Scale. The spatial-temporal gait parameters and foot pressure distribution were assessed with the Zebris FDM-THM-S treadmill system before and after the treatment. At posttreatment assessment, there were significant changes in step length, stance phase percentage, swing phase percentage, and gait speed (P < 0.05), except step width and cadence (P > 0.05). Moreover, significant differences were found in forefoot, midfoot, and rearfoot pressure distribution (P < 0.05). There was also a significant decrease in pain intensity during activity compared to the pretreatment (P < 0.05). Our study results suggest that the combination of the custom-made insoles and exercise program created improvements in spatial-temporal gait parameters and foot pressure distribution by reducing the pain severity.

Successful Application of an Insole with a Metatarsal Inhibition Bar and Deep Heel Cup for Improving Gait Dysfunction in a Patient with Poor Coordination with Disrupted Corticoreticular Tracts: A Case Report

We report the successful management of gait dysfunction in a patient with coordination problems using an insole with a metatarsal inhibition bar (MIB) and a deep heel cup. Furthermore, we investigated the state of the neural tracts via diffusion tensor tractography (DTT). A 23-month-old boy with gait dysfunction presented with toe walking with a wide base and decreased hip flexion. Motor weakness or spasticity was not observed. Conventional brain magnetic resonance imaging did not reveal any abnormal findings, but DTT revealed disrupted bilateral corticoreticulospinal tracts (CRTs). No abnormalities were observed in the corticospinal tract or the medial lemniscus. We applied a custom-made insole with an MIB and a deep heel cup. Immediately after application, the patient’s gait pattern stabilized significantly and was nearly normalized. Our therapeutic experience indicates that the application of an insole with an MIB and deep heel cups could be beneficial for patients with coordination problems and gait dysfunction. Our DTT results showed that CRTs could be the causative brain pathology for gait dysfunction in patients with coordination problems.