Custom-made Orthotics Research Articles

Effects of a range of 6 prefabricated orthotic insole designs on plantar pressure in a healthy population: A randomized, open-label crossover investigation.

Prefabricated orthotic insoles are widely commercially available for self-selection to treat foot and lower-body musculoskeletal pain, without requiring advice from health care professionals. Although they are generally designed to mimic traditional design features of custom-made orthotics used in clinical practice, the effects of prefabricated insoles on plantar pressure distribution are poorly understood. This investigation aimed to evaluate and directly compare the effects of a range of 6 different commercially available prefabricated orthotic insole designs on plantar pressure in healthy individuals. This was a single-center, randomized, open-label, crossover investigation. In-shoe dynamic pressure (F-scan) was investigated in 24 healthy subjects with normal foot posture, wearing standard shoes alone and in combination with 6 different orthotic insoles, consecutively, measured on a single day. The biomechanical impact of each insole was determined by the statistical significance of changes from baseline measurements (standard shoe alone). Insoles with heel cups and medial arch geometries consistently increased contact area at medial arch and whole-foot regions and reduced both plantar peak pressure (PP) and pressure time integral at medial arch and heel regions. This investigation has aided in further understanding the mode of action of prefabricated insoles in a healthy population. The insoles in this study redistributed plantar pressure at key regions of the foot, based on design features common to prefabricated insoles. Prefabricated orthotic insoles represent an easily accessible means of reducing lower-body musculoskeletal stress for those who spend prolonged periods of time on their feet.

The Impact of Podiatric Intervention on the Quality of Life and Pain in Children and Adolescents with Hypermobility.

The purpose of this study was to evaluate the effect of custom-made orthotics on pain, health-related quality of life (HRQoL), function and fatigue in children and adolescents with generalised joint hypermobility (GJH) and lower limb pain. Fifty-three children aged 5-18 years were fitted with custom-made polypropylene orthotics. Visual analogue scale (VAS) assessed lower limb pain severity, Paediatric Quality of Life Inventory assessed HRQoL and fatigue and six-minute walk test (6 MWT) measured functional endurance at baseline, at 1 month and 3 months post-intervention. A mixed model including a random intercept for participant and a fixed effect for time was used to assess differences in outcomes over time. Fifty-two children completed the study (mean age 10.6-years). Children reported significantly reduced pain (mean VAS reduction -27/100, 95%CI: -33, -21), improved HRQoL (mean total improvement 11/100, 95%CI: 7, -15), functional capacity (mean 6MWT improvement 27 m, 95%CI: 18, -36) and fatigue (mean total improvement 13/100, 95%CI: 9, -17) after 1 month of wearing the custom-made orthotics. From 1 month to 3 months there was further statistically but not clinically significant reduction in pain while benefit on other outcomes was maintained. In this study, children with GJH reported reduced lower limb pain, improved HRQoL, functional endurance and fatigue after a month post-fitting of custom-made orthotics which was maintained over a 3 month period. Orthotics were well-tolerated with no serious adverse events reported.

Custom-Made Foot Orthotics for People With Lower Limb Conditions


 There were no statistically significant differences between custom-made foot orthotics and prefabricated foot orthotics for plantar heal pain in adults.
 There is limited evidence for short-term pain relief and improved quality of life with custom-made orthotics compared to placebo or no intervention in adults with plantar fasciitis.
 Custom-made foot orthotics are less cost-effective than other interventions (placebo, prefabricated orthotics, usual care) in the short and medium term.
 Two evidence-based guidelines recommended the use of custom-made foot orthotics in patients with diabetes for prevention and treatment of foot ulceration.

Effectiveness of Custom-Made Foot Orthoses vs. Heel-Lifts in Children with Calcaneal Apophysitis (Sever’s Disease): A CONSORT-Compliant Randomized Trial

The aim of the present research was to determine the effectiveness of relieving calcaneal apophysitis pain using “off-the-shelf” heel-lifts and custom-made orthotics. Two intervention modalities were evaluated and compared in a 12-week follow-up trial. Inclusion criteria included 9- to 12-year-old children diagnosed with calcaneal apophysitis. Children were randomly stratified into treatment A (custom-made polypropylene foot orthoses) and treatment B (“off-the-shelf” heel-lifts) groups. Treatment effectiveness was measured by algometry and the visual analogical scale (VAS). A total of 208 patients were included. The treatment A group showed an increase in threshold algometry of 53.4% (95% CI 47.1% to 59.7%) and a decrease in VAS of −68.6% (95% CI −74.5% to −62.7%) compared with the treatment B group (p < 0.001). Calcaneal apophysitis pain perception was improved in both groups, but children who used custom-made foot orthoses showed a greater improvement.

INFLUENCE OF CUSTOMIZED FOOT ORTHOTICS ON GAIT BALANCE FOR PELVIC ASYMMETRY PATIENTS

Gait is one of the most common and important factor of human movements in daily life. Pelvis is closely connected with the gait due to it allows maintain stable posture by supporting the spine and lower extremities against the gravity. Therefore, pelvic asymmetry, which is caused by biomechanical stress and muscle imbalance, has been associated with postural imbalance and abnormal walking pattern. The purpose of this study was to manufacture customized foot orthotics for improving gait balance and evaluate the effectiveness of customized foot orthotics during walking by measuring lower extremity muscle activity and plantar pressure distribution. All subjects with pelvic asymmetry were asked to walk on a treadmill under three conditions: walking without foot orthotics, walking with customized foot orthotics and walking with non-customized foot orthotics. Root mean square (RMS) value of the electromyography signals, force and peak pressure of the plantar pressure distribution was analyzed based on the gait cycle. The results showed that excessive tension of the muscles and high pressure of the foot that was induced by pelvic asymmetry were more reduced when walking with custom-made foot orthotics than walking without foot orthotics and walking with non-customized foot orthotics. This paper suggest that custom-made orthotics for patients with pelvic asymmetry could be helpful to relieve the excessive loading of the foot and maintain balanced gait pattern.

Short-term effectiveness of Scarf osteotomy and Akin osteotomy combined with soft tissue procedures in treatment of hallux valgus associated with mild to moderate metatarsus adductus

To evaluate the short-term effectiveness of Scarf osteotomy and Akin osteotomy combined with soft tissue procedures for hallux valgus associated with mild to moderate metatarsus adductus. The clinical data of 30 patients (48 feet) who were diagnosised hallux valgus associated with mild to moderate metatarsus adductus and treated by Scarf osteotomy and Akin osteotomy combined with soft tissue procedures between February 2013 and May 2015 were analyzed retrospectively. There were 2 males (2 feet) and 28 females (46 feet) with an average age of 29.4 years (range, 18-50 years). The disease duration was 3-12 years (mean, 6.1 years). The degree of metatarsal adductus was assessed by Sgarlato's measurement and Yu et al classification criteria, and the degree of metatarsal adductus was mild in 20 feet and moderate in 28 feet. Preoperative X-ray examination showed that the hallux valgus angle (HVA) was (39.4±5.6)°, the first-second intermetatarsal angle (1-2IMA) was (15.2±3.5)°, the metatarsus adductus angle (MAA) was (21.2±3.7)°. The American Orthopaedic Foot and Ankle Society (AOFAS) score was 51.7±10.0, and visual analogue scale (VAS) score was 4.9±2.7 before operation. Postoperative complications and the union time of osteotomies were recorded. At last follow-up, the HVA, 1-2IMA, and MAA were measured on X-ray films, and the AOFAS scores and VAS scores were recorded, then compared them with preoperative ones. Roles - Maudsley score was used to investigate patients' satisfaction. All the incisions healed by first intention. Thirty patients were followed up 24-27 months (mean, 26.4 months). Three patients (4 feet) occured metatarsalgia, and the pain relieved after treated by Custom-Made Orthotics. All the osteotomies were unoin, the healing time was 2-4 months (mean, 2.7 months). At last follow-up, the HVA and the 1-2IMA were (13.2±3.1)° and (5.1±2.3)°, respectively, showing significant differences when compared with preoperative ones ( t=14.606, P=0.000; t=22.356, P=0.000); the MAA was (21.0±3.4)° and there was no significant difference when compared with preoperative one ( t=0.789, P=0.434). The AOFAS and VAS scores were 91.8±7.5 and 1.1±1.0, respectively, showing signifiant differences when compared with preoperative ones ( t=13.787, P=0.000; t=14.781, P=0.000). Satisfaction survey showed that 28 patients were very satisfied and satisfied (93.3%), and 2 cases were not satisfied (6.7%). The short-term effectiveness of Scarf osteotomy and Akin osteotomy combined with soft tissue procedures for hallux valgus associated with mild to moderate metatarsus adductus is satisfactory, and no correction is required for metatarsal adductus.

Shoe Orthotics for the Treatment of Chronic Low Back Pain: A Randomized Controlled Trial

ObjectivesTo investigate the efficacy of shoe orthotics with and without chiropractic treatment for chronic low back pain compared with no treatment. DesignRandomized controlled trial. SettingIntegrative medicine teaching clinic at a university. ParticipantsAdult subjects (N=225) with symptomatic low back pain of ≥3 months were recruited from a volunteer sample. InterventionsSubjects were randomized into 1 of 3 treatment groups (shoe orthotic, plus, and waitlist groups). The shoe orthotic group received custom-made shoe orthotics. The plus group received custom-made orthotics plus chiropractic manipulation, hot or cold packs, and manual soft tissue massage. The waitlist group received no care. Main Outcome MeasuresThe primary outcome measures were change in perceived back pain (numerical pain rating scale) and functional health status (Oswestry Disability Index) after 6 weeks of study participation. Outcomes were also assessed after 12 weeks and then after an additional 3, 6, and 12 months. ResultsAfter 6 weeks, all 3 groups demonstrated significant within-group improvement in average back pain, but only the shoe orthotic and plus groups had significant within-group improvement in function. When compared with the waitlist group, the shoe orthotic group demonstrated significantly greater improvements in pain (P<.0001) and function (P=.0068). The addition of chiropractic to orthotics treatment demonstrated significantly greater improvements in function (P=.0278) when compared with orthotics alone, but no significant difference in pain (P=.3431). Group differences at 12 weeks and later were not significant. ConclusionsSix weeks of prescription shoe orthotics significantly improved back pain and dysfunction compared with no treatment. The addition of chiropractic care led to higher improvements in function.

Long-term follow up (2 years) of highly standardized custom-made orthotics in the treatment of metatarsalgia: a patient satisfaction study

Long-term follow up (2 years) of highly standardized custom-made orthotics in the treatment of metatarsalgia: a patient satisfaction study

Effects of Foot Orthotics on Running Economy: Methodological Considerations

ObjectiveThe purpose of the study was to collect preliminary data to address methodological considerations that may impact subject-specific reactions to foot orthotics during running. MethodsSix endurance-trained recreational runners recruited from a chiropractic college campus wore their preferred running shoes and then inserted either their custom-made orthotics during 1 testing session or their shoe-fitted insoles during the other testing session. Comfort perception was measured for each footwear condition. Measurements of oxygen consumption (Vo2) at several moderate exercise intensities, to mimic recreational running, generated an individual's economy-of-running line. Predicted running velocity at Vo2max (vVo2max) was calculated as an index of endurance performance. Lower extremity muscle activity was recorded. Descriptive statistics, a repeated-measures analysis of variance model, and a paired t test were used to document any systematic changes in running economy, lower extremity muscle activities, and vVo2max within and across subjects as a function of footwear conditions. ResultsDecreases in Vo2 at several moderate exercise intensities (F(1,5)footwear = 10.37, P = .023) and increases in vVo2max (t5 = 4.20, P = .008) occurred in all 6 subjects while wearing their orthotic intervention vs their shoe-fitted insoles. There were no consistent changes in lower extremity muscle activity. ConclusionsMethodological decisions to use a sustained incremental exercise protocol at several moderate exercise intensities and to measure comfort perception of a custom-molded foot orthosis were effective at documenting systematic improvements in running economy among the 6 recreational runners tested. The development of a less physically demanding sustained exercise protocol is necessary to determine underlying neuromuscular mechanisms and/or clinical effectiveness of orthotic interventions.

Shoe Orthotics for the Treatment of Chronic Low Back Pain: A Randomized Controlled Pilot Study

Objectives The purpose of this pilot study was to investigate the feasibility of a randomized clinical trial of shoe orthotics for chronic low back pain. Methods The study recruited 50 patients with chronic low back pain through media advertising in a midwestern suburban area. Medical history and a low back examination were completed at a chiropractic clinic. Subjects were randomized to either a treatment group receiving custom-made shoe orthotics or a wait-list control group. After 6 weeks, the wait-list control group also received custom-made orthotics. This study measured change in perceived pain levels (Visual Analog Scale) and functional health status (Oswestry Disability Index) in patients with chronic low back pain at the end of 6 weeks of orthotic treatment compared with no treatment and at the end of 12 weeks of orthotic treatment. Results This study showed changes in back pain and disability with the use of shoe orthotics for 6 weeks compared with a wait-list control group. It appears that improvement was maintained through the 12-week visit, but the subjects did not continue to improve during this time. Conclusions This pilot study showed that the measurement of shoe orthotics to reduce low back pain and discomfort after 6 weeks of use is feasible. A larger clinical trial is needed to verify these results.

Effects of exercise and custom-made orthotics on blood pressure and heart rate variability: a randomized controlled pilot study

Objective The objective of this study is to use randomized controlled research design to investigate the effect of an exercise program and custom-made flexible orthotics on heart rate variability and blood pressure at varying stages of exercise over a 5-month period. Methods Thirteen ping-pong players were recruited and randomly assigned into control and experimental groups. Both groups had the same exercise program, and only the experimental group wore custom-made flexible orthotics. Exercise effects were compared before and after the training using heart rate variability and blood pressure. The study lasted 5 months with 1 data collection per month except in the fourth month. Results Ten male players (6 in the experimental group) completed the study. The average age of the participants was 44 ± 16 years. The blood pressure in the experimental group significantly decreased after the 5-month study period and after each exercise session. The blood pressure did not change significantly after each exercise session in the control group. The heart rate was significantly increased immediately after exercise and remained at a higher level after the 20 minutes of rest at the end of each day's exercise session. The average resting heart rate decreased from 69.7 ± 1.708 to 66.8 ± 4.480 ( P < .05) in the experimental group but increased from 69.7 ± 1.708 to 90.7 ± 2.808 ( P > .05) in the control group. The total power reflecting the total autonomic activity was significantly decreased immediately after exercise and after the 20-minute rest period at the end of the exercise session in both the control and experimental groups. Conclusions There were positive changes in cardiac and vascular autonomic regulations with exercise training when combined with foot orthotics.

EFFECT OF CUSTOM ORTHOTICS ON PEAK PLANTAR PRESSURE IN SUBJECTS WITH 7 OR MORE DEGREES OF FOREFOOT VARUS

The purpose of this study was to determine the effects of custom-made orthotics (Sole Supports, Inc., Bon Aqua, TN) on peak plantar pressure in subjects with ≥ 7 degrees of forefoot varus. Fourteen subjects (8 males, 6 females) (mean age = 29 ± 6 yrs; mean ht = 170.3 ± 7.9 cm; mean wt = 74.1 ± 15.4 kg) were assessed for goniometric measures of forefoot varus bilaterally. Subjects were excluded unless they had at least 7 or more degrees of forefoot varus bilaterally. Subjects were casted for custom-made orthotics using a dynamic casting technique (Sole Supports, Inc.). Orthotics were custom-made for each subject according to the casts. An EMED Pedar system (Novel Electronics, Inc., St. Paul, MN) was used to assess plantar pressures under 9 regions of the left foot. Subjects walked 30 meters on a level floor at an average preset velocity of 1.0 m/sec. The same standard court shoes were worn with and without orthotics by each subject during plantar pressure assessment. Results from paired t-tests indicated that wearing the orthotics significantly reduced peak pressure (p ≤ 0.05) in the medical heel, lateral heel, medial forefoot, and middle forefoot regions when compared to wearing a court shoe only. Peak plantar pressure was significantly increased in the midfoot, middle and lateral toe regions (p ≤ 0.05). These data suggest that wearing a custom-made orthotic may signficantly reduce peak plantar pressure in areas of the foot that may be at risk for injury such as the metatarsal and heel regions.