Effects of ankle-foot orthoses on gait parameters in post-stroke patients with different Brunnstrom stages of the lower limb: a single-center crossover trial.

BACKGROUND: Ankle-foot orthoses (AFO) can improve gait posture and walking ability in post-stroke patients. However, the effect of AFO on gait parameters in post-stroke patients according to the Brunnstrom stage of stroke recovery of the lower limbs remains unclear. The study aimed to investigate whether stroke patients with different Brunnstrom stages benefit from wearing AFO. METHODS: Twenty-five post-stroke participants included 18 men (50 ± 13 years) and 7 women (60 ± 15 years). The patients were divided based on Brunnstrom stage III or IV of the lower limbs. All patients underwent the gait and timed up and go (TUG) test using a gait analysis system while walking barefoot or with an AFO. The spatiotemporal and asymmetric parameters were analyzed. RESULTS: All 25 patients completed the study. Significant differences were observed between barefoot and AFO use in TUG time (P < 0.001) but not walking velocity (P > 0.05). The main effect of the swing time ratio was significant in both groups (P < 0.05); however, the main effects of stride length, stance time, and gait asymmetry ratio were nonsignificant (P > 0.05). For barefoot versus AFO, the main effects of stride length (P < 0.05) and swing time (P < 0.01) ratios were significant, whereas those of stance time and gait asymmetry ratio were nonsignificant (P > 0.05). CONCLUSIONS: Post-stroke patients with lower Brunnstrom stages benefitted more from AFO, particularly in gait asymmetry.

In-Shoe Pressure Measurements in Diabetic Footwear Practice: Success Rate and Facilitators of and Barriers to Implementation.

We aimed to assess the success rate and facilitators of and the barriers to the implementation of in-shoe plantar pressure measurements in footwear practice for people with diabetes at high risk of foot ulceration. Eleven Dutch footwear practices were partly supported in purchasing a pressure measurement system. Over a 2.5-year period, trained shoe technicians evaluated 1030 people with diabetes (range: 13 to 156 across practices). The implementation success and associated facilitators and barriers were evaluated quantitatively using completed measurement forms and pressure measurement data obtained during four monitoring sessions and qualitatively through semi-structured interviews with technicians. Across the 11 practices, the primary target group (people with diabetes and a healed plantar foot ulcer) represented 25-90% of all the patients measured. The results showed that three practices were successful, five moderately successful, and three not successful. The facilitators included support by the company management board, collaboration with a prescribing physician, measurement sessions separate from the outpatient clinic, and a (dedicated) shoe technician experiencing a learning effect. The barriers included investment costs, usability aspects, and limited awareness among shoe technicians. In-shoe plantar pressure measurements can be implemented to a moderate to large degree in diabetic footwear practice. The barriers to and facilitators of implementation are organizational, logistical, financial, or technical, and the barriers are modifiable, supporting future implementation.

In-silico simulations to study the effects of ankle-joint misalignments in Ankle-Foot-Orthoses during level walking.

Exoskeletons and orthotic devices are commonly used in physical rehabilitation. However, these devices, fitting intimately with the human body, often lead to skin-related issues amongst users. Misalignments between orthotic and anatomical joints cause relative sliding motion between the limb and orthosis and also cause pressure points on the limb, which may contribute to these skin problems. This research quantifies the effects of sagittal plane ankle-joint misalignments for an ankle-foot orthosis (AFO) user during walking. A 2D mathematical model that simulates the effects of sagittal plane ankle-joint misalignments in terms of relative motion between the limb and the orthosis was developed using MATLAB software. The orthotic ankle-joint was systematically misaligned against the anatomical ankle-joint to generate various misalignment conditions. Published gait data of 5 healthy subjects was used to generate walking kinematics which was then superimposed with an articulated AFO. The simulations showed that Anterior-Posterior misalignments resulted in greater pistoning motion than Proximal-Distal misalignments. Combined misalignments (Posterior-Distal, Anterior-Proximal, Posterior-Proximal, and Anterior-Distal) resulted in higher overall relative motions between the limb and AFO. The model also predicted pressure points on the shank and foot caused by misalignments. This study demonstrates that misaligned ankle-joints in AFOs lead to relative sliding motion and pressure points during walking.

Comparison between prefabricated ankle-foot orthoses, Dyna Ankle and UD Flex, in patients with hemiplegia.

OBJECTIVE: To compare the kinematic effects of two widely-used prefabricated ankle-foot orthoses (AFOs), the Dyna Ankle (DA) and UD Flex (UD), on the gait cycle of patients with hemiplegia due to cerebral palsy or acquired brain injury. METHODS: This was a retrospective cohort study involving 29 patients. Gait analysis results were assessed under three conditions: barefoot, with the DA, and with the UD. Friedman tests and post hoc analysis with Bonferroni correction were performed to assess differences between the three conditions. RESULTS: The DA significantly improved ankle dorsiflexion during the mid-swing phase, making it more effective in correcting foot drop compared with the UD (DA: 2.28°, UD: 0.44°). Conversely, the UD was more effective in preventing knee flexion during the loading response (DA: 28.11°, UD: 26.72°). CONCLUSIONS: The DA improved ankle dorsiflexion during the swing phase significantly more than that with the UD in patients with hemiplegia. Compared with the DA, the UD more effectively prevented increased knee flexion during the loading response. The choice to prescribe these orthoses should consider individual patient characteristics.

Effect of foot orthoses on balance among individuals with flatfoot: A systematic review and meta-analysis.

Individuals with flatfoot have impaired proprioception owing to ligament laxity and impaired tendons, which can result in poor balance. Foot orthoses (FOs) have been reported to stimulate plantar mechanical receptors and are used to manage foot overpronation in individuals with flatfoot. However, the results of the use of FOs to improve balance are inconsistent. In this systematic review and meta-analysis, we aimed to identify and investigate the effects of FOs on balance in individuals with flatfoot. Electronic databases were searched for articles published before March 2023. Peer-reviewed journal studies that included adult participants with flexible flatfoot and reported the effects of FOs on balance were included and classified based on the study design: randomized control trials (RCT) and non-RCTs. Four RCT studies were retained, and their methodological quality was assessed (mean, 63.2%; range 47.3%-73.1%: high), as were three non-RCT studies (mean, 54.1%; range, 42.1%-68.4%: high). Meta-analysis was performed by calculating the effect size using the standardized mean differences between the control and FO conditions. Transverse-arch insoles immediately improved static balance after use. However, no immediate significant effect was found for medial archsupport FOs, cuboid-posting FOs, or University of California Berkeley Laboratory FOs during the study period (2-5 weeks) when compared with the controls. The transverse-arch insole is the most effective FO feature for improving static balance. However, the high heterogeneity between study protocols contributes to the lack of evidence for the effects of FO on balance in people with flatfoot.

Effectiveness of gait plate insole and lateral sole wedged shoes on foot progression angle in children with in-toeing gait: A prospective randomized control trial.

BACKGROUND: In-toeing gait is defined as the internal rotation of the long axis of the foot to the line of progression. Although most of the time it is corrected spontaneously but sometimes causes torsional misalignment syndrome and maybe patellofemoral instability and arthritis of the knee. RESEARCH QUESTION: What is the effect of gait plate insoles and lateral sole wedged shoes on foot progression angle (FPA) in children with in-toeing? METHOD: In this study, a randomized control trial was conducted with 11 participants (18 feet) who were girls aged between seven and ten years old. They were randomly assigned to either the gait plate group (6 girls, 11 feet) or the lateral sole wedge group (5 girls, 11 feet). The foot progression angle was measured using the RS scanner pressure platform before and after four weeks of intervention, both with and without interventions. The interaction effects of time and group on outcomes were analyzed using Mixed ANOVA and post-hoc complementary tests with a confidence interval of 95%. RESULTS: It was observed that none of the interventions had an immediate impact on the FPA (P > 0.05). However, after four weeks, the FPA increased by 9.96 degrees with the lateral sole wedge and by 3.51 degrees with the gate plate insole. During the immediate and short-term evaluation, no significant difference was noticed between the two groups (P > 0.05). However, there was a large effect size (eta square = 0.269) observed in the time group interaction between the two groups (P = 0.028). SIGNIFICANCE: Conservative methods like using a gait plate insole or modifying shoes with a lateral sole wedge can improve the foot progression angle in children with in-toeing gait. However, longer studies with larger sample sizes are needed to reach a conclusion.

Effects of foot orthoses on running kinetics and kinematics: A systematic review and meta-analysis.

BACKGROUND: Foot orthoses (FOs) are often prescribed by clinicians to treat foot and ankle conditions, prevent running injuries, and enhance performance. However, the lack of higher-order synthesis of clinical trials makes it challenging for clinicians to adopt an evidence-based approach to FOs' prescriptions. RESEARCH QUESTION: Do FOs with different modifications alter lower extremity running kinematics and kinetics? METHODS: A systematic search of seven databases was conducted from inception to February 2023. The analysis was restricted to healthy adults without foot musculoskeletal impairments and studies that compared the FOs effects with the controls. The methodological quality of the 35 studies that met the eligibility criteria was evaluated using the modified Downs and Black checklist. The random effects model estimated the standardized mean difference (SMD) with 95% confidence intervals and effect sizes. Sub-group analyses based on FOs type were performed to assess the potential effects of the intervention. RESULTS: Our findings indicated that both custom and off-the-shelf arch-support FOs reduced peak plantar pressure at the medial heel (SMD=-0.35, and SMD=-1.03), lateral heel (SMD=-0.50, and SMD=-0.53), and medial forefoot (SMD=-0.20, and SMD=-0.27), but increased plantar pressure at the mid-foot (SMD=0.30, and SMD=0.56). Compared with the controls, significant increases (SMD=0.36) in perceived comfort were found with custom FOs. A reduction (SMD=-0.58) in initial ankle inversion was found when a raised heel cup was integrated with arch-support FOs. A medial post integrated with arch support exhibited a reduced ankle (SMD=-1.66) and tibial (SMD=-0.63) range of motion. Custom FOs, however, unfavorably affected the running economy (SMD=-0.25) and perceived exertion (SMD=0.20). SIGNIFICANCE: Although FOs have been reported to have some positive biomechanical effects in healthy populations without musculoskeletal impairments or running-related issues, they need to be optimized and generalized to achieve better running performance and prevent injury.

The importance of foot posture when recording lower leg electromyography when walking in non-textured and textured foot orthoses.

Foot posture describes the anatomical variance in an individual's overall foot shape, an important consideration in the provision of foot orthoses. Current orthoses designs could be optimized by considering the topographical organization of cutaneous mechanoreceptors. Currently, the effect of foot orthoses designs to enhance skin stimulation across different anatomical foot posture remains unknown. Thus, the purpose of this study was to investigate how foot posture variance modulates lower leg muscle activity when walking in non-textured orthoses and in textured orthoses which facilitates cutaneous mechanoreceptors under five different regions of the foot sole. Fifty-one (51) healthy young adults were subdivided by the Foot Posture Index and completed level walking trials wearing non-textured and textured foot orthoses. Surface and fine-wire electromyography (EMG) recorded muscle activity in 8 lower leg muscles. Statistically significant interactions were observed in each muscle's average EMG across textured location and Foot Posture Index score. For example, in pes cavus compared to pes planus feet, texture under the calcaneus generated greater aEMG of the tibialis anterior (44.9 mV ± 22.7 mV to 30.9 mV ± 11.4 mV) medial gastrocnemius (26.1 mV ± 16.7 mV to 17.5 mV ± 6.0 mV), and tibialis posterior (84.4 mV ± 77.1 mV to 64.4 mV ± 44.5 mV) muscles. This study demonstrates that lower leg muscle activity is modulated across the foot posture spectrum wearing non-textured and textured foot orthoses. Furthermore, in the development of new orthoses designs, specifically with texture, foot posture remains an important consideration when clinicians interpret EMG results and academics are designing new experimental protocols.

Determination of Gait Events and Temporal Gait Parameters for Persons with a Knee-Ankle-Foot Orthosis.

Gait event detection is essential for controlling an orthosis and assessing the patient's gait. In this study, patients wearing an electromechanical (EM) knee-ankle-foot orthosis (KAFO) with a single IMU embedded in the thigh were subjected to gait event detection. The algorithm detected four essential gait events (initial contact (IC), toe off (TO), opposite initial contact (OIC), and opposite toe off (OTO)) and determined important temporal gait parameters such as stance/swing time, symmetry, and single/double limb support. These gait events were evaluated through gait experiments using four force plates on healthy adults and a hemiplegic patient who wore a one-way clutch KAFO and a pneumatic cylinder KAFO. Results showed that the smallest error in gait event detection was found at IC, and the largest error rate was observed at opposite toe off (OTO) with an error rate of -2.8 ± 1.5% in the patient group. Errors in OTO detection resulted in the largest error in determining the single limb support of the patient with an error of 5.0 ± 1.5%. The present study would be beneficial for the real-time continuous monitoring of gait events and temporal gait parameters for persons with an EM KAFO.

Medially wedged foot orthoses generate greater biomechanical effects than thin-flexible foot orthoses during a unilateral drop jump task on level and inclined surfaces.

BACKGROUND: Foot orthoses are therapeutic insoles designed to induce various effects on lower limb biomechanics. However, conflicting findings in previous research, highlight the need to better understand how foot orthoses with different features affect lower limb biomechanics during challenging tasks, particularly during unilateral drop jump landings. METHODS: Seventeen participants with flat feet were recruited to participate in this cross-sectional descriptive study that examined the effects of thin-flexible foot orthoses and medially wedged foot orthoses on lower limb biomechanics during unilateral drop jump landings on level and valgus inclined surfaces. Midfoot, ankle, knee, and hip angles and moments were calculated and compared across conditions with repeated measures ANOVAs, using a statistical parametric mapping approach. FINDINGS: Medially wedged and thin-flexible foot orthoses reduced ankle pronation and arch flattening during unilateral drop jump landings on level and valgus inclined surfaces. Medially wedged foot orthoses further decreased midfoot dorsiflexion and ankle eversion angles compared to thin-flexible foot orthoses. Medially wedged foot orthoses also generated greater effects on ankle kinetics and hip kinematics during unilateral drop jump landings. INTERPRETATION: Medially wedged foot orthoses are more effective than thin-flexible foot orthoses in optimizing lower limb biomechanics during unilateral drop jump landings. While the biomechanical effects did not increase on inclined surfaces, medially wedged foot orthoses generated greater effects on proximal joints, highlighting their potential to improve hip stability and enhance overall lower limb function. Personalized foot orthoses selection based on specific biomechanical profiles should be further explored to optimize orthotic interventions benefiting individuals with musculoskeletal conditions.

Functional evaluation of a novel fibreglass-reinforced polyamide custom dynamic AFO for foot drop patients: A pilot study.

BACKGROUND: Ankle-foot orthoses (AFOs) are orthopaedic devices often prescribed to treat foot drop. For patients who are not satisfied with off-the-shelf solutions, custom AFOs personalized to the patient's lower limb anatomy are required. Dynamic AFOs provide stability while allowing for physiological ankle mobility in the stance phase of walking. RESEARCH QUESTION: Can a morphology-based dynamic custom AFO made of fiberglass-reinforced polyamide restore a quasi-normal gait pattern and improve comfort in patients with foot drop? METHODS: In this pilot study, the legs and feet of ten foot drop patients (age=64.9 ± 11.4 years; BMI=26.2 ± 2.1 kg/m2) were scanned using a Kinect-based 3D scanner. A custom AFO was designed and produced for each patient using a fiberglass-reinforced polyamide through selective laser sintering. To assess kinematics, skin markers were placed on relevant bony landmarks according to a validated protocol. Each patient was instructed to walk at a self-selected comfortable speed under three conditions: wearing the custom AFO, wearing an off-the-shelf orthosis (Codivilla spring), and without any AFO (shod condition). Muscle activation in the tibialis anterior, gastrocnemius, rectus femoris and biceps femoris muscles in both legs was recorded using wireless sEMG sensors. The comfort and of each AFO was evaluated using a Visual Analogue Scale. RESULTS: The custom AFO resulted in significant increase of stride length and walking speed compared to the shod condition. Except for the hip joint, which exhibited greater maximum flexion and reduced range of motion, the kinematic parameters of all other joints were similar to those observed in a healthy control population. Furthermore, the custom AFO received significantly higher comfort scores compared to the Codivilla spring. SIGNIFICANCE: This study has provided evidence supporting the effectiveness of custom orthotic solutions in restoring lower limb kinematics and improving the perceived comfort in foot drop patients compared to off-the-shelf solutions.

Comparison of 2 Conservative Treatment Approaches for the Flat Foot in Children Aged 5 to 10: Foot Orthoses Versus Foot Orthoses Supplemented With Zukunft-Huber Manual Therapy.

The aim was to find if foot orthotics alone can improve flat feet in children and analyze how the addition of Zukunft-Huber manual therapy and corrective bandaging changes the outcome. Forty-nine children aged 5 to 10 with asymptomatic flexible flat feet were divided into 2 groups. The first was treated with foot orthoses alone, in the second wearing foot orthoses was supplemented with Zukunft-Huber manual therapy and corrective bandaging. Pedobarography during gait was performed before the therapy and after a year. In the first group decrease in arch index, width, force, and area of midfoot, increase in force MH2 and area hindfoot was found, in the second decrease in arch index, width, force, and area of midfoot, increase in force under metatarsal head second, third, fourth, and fifth, area metatarsal head fourth and area hindfoot. Both methods showed positive changes, but foot orthoses with additional intervention were more effective.

Safety, walking ability, and satisfaction outcomes of the NEURO TRONIC stance-control knee-ankle-foot orthosis (SCKAFO): A comparative evaluation to the E-MAG active SCKAFO.

BACKGROUND: Stance control knee-ankle-foot orthoses (SCKAFOs) ensure knee stability by locking during stance while allowing knee flexion during swing. Differences in function of the knee joints and building principles between devices may affect their effectiveness. OBJECTIVE: To investigate the preliminary effectiveness of a NEURO TRONIC on safety outcomes, net energy cost (EC), and user experiences in individuals already using an E-MAG Active SCKAFO. STUDY DESIGN: Prospective uncontrolled intervention study. METHODS: A convenience sample of 10 subjects with flaccid lower extremity muscle weakness, including the quadriceps, due to neuromuscular disorders already using an E-MAG Active SCKAFO were provided with a newly fabricated NEURO TRONIC SCKAFO. Outcomes included knee joint locking failures and unlocking failures (ULFs) (i.e., percentage of steps the knee joint failed to lock/unlock) when walking under challenging conditions on an instrumented treadmill while wearing a safety harness; net EC (J/kg per meter) assessed with a 6-min walk test at comfortable speed; 3D gait kinematics and kinetics; and patient-reported outcomes. RESULTS: No differences between devices were found for knee joint locking failures (both devices 0%) and ULFs (9.9% for the NEURO TRONIC vs. 13.9% for the E-MAG Active SCKAFO). The mean (standard deviation) net EC with the NEURO TRONIC SCKAFO was 8.2% (from 3.68 [0.81] to 3.38 [0.75] J/kg per meter, p = 0.123) lower, although not significantly, compared with that with the E-MAG Active SCKAFO. Significant improvements with the NEURO TRONIC SCKAFO were found for ankle power ( p = 0.003), perceived walking effort ( p = 0.014), and reported falls ( p = 0.034). CONCLUSION: Both the NEURO TRONIC SCKAFO and the E-MAG Active SCKAFO were safe in terms of knee joint locking, while ULFs were frequent with both devices. The net EC with the NEURO TRONIC SCKAFO decreased, although not significantly, by 8.2%, likely due to insufficient power. Perceived walking effort was in favor of the NEURO TRONIC SCKAFO.

Does medial calcaneal wedge improve static balance and load distribution in young adults with pronated foot?

BACKGROUND: Foot orthoses changing the momentum in the subtalar joint are often recommended, especially in activities loading the foot, to bring the pronated foot posture closer to neutral. OBJECTIVES: To examine the immediate effect of medial heel wedge on static balance and load distribution in patients with increased pronation in the foot. STUDY DESIGN: Experimental study design. METHODS: Forty people with right dominant lower extremity participated in the study. For static balance assessment, we assessed ellipse surface, sway length, x-y mean, AP index, and Romberg ratio on 1 foot and measured load distribution as right-left foot and fore-hind foot with and without wedge. RESULTS: There was a difference between the parameters of the ellipse surface and the Romberg ratio on the left side in the measurements performed with and without wedge for static balance on the left side ( P < 0.05) while there was no difference in the remaining values ( P > 0.05). In the load distribution, the change in the right anteroposterior foot was significant, increasing the load on the forefoot with the wedge ( P < 0.05) while we observed no difference in the left fore-hind foot load distribution and right-left foot load distribution ( P > 0.05). CONCLUSION: Our study showed that for static balance, medial wedge can improve balance on the left side by decreasing sway, and for load distribution, the medial wedge changed the load distribution from back to front on the right side. These small differences in young healthy individuals are a preliminary indication that further studies are needed.

Design and mechanical testing of an adjustable posterior leaf spring ankle-foot orthosis for patients with drop foot.

OBJECTIVES: This study aimed to design an adjustable posterior leaf spring (PLS) ankle-foot orthosis (AFO) with an affordable material in low-income countries and investigate the mechanical properties between an adjustable PLS AFO and a standard PLS AFO. STUDY DESIGN: Static and dynamic mechanical testing. METHODS: This study preliminarily tested a new adjustable PLS AFO against a standard PLS AFO. Each AFO design was tested with mechanical testing using an Instron 8801 universal testing machine. RESULTS: The stiffness value of the adjustable PLS AFO was greater than that of the standard PLS AFO during the static loading test. The energy dissipated ratios were lower in the adjustable PLS AFO than in the standard PLS AFO. After 110,000 cycles of fatigue testing, the distal rivet of the adjustable PLS AFO became loose, although the standard PLS AFO had no problem. CONCLUSIONS: The novel adjustable PLS AFO achieved noninferior mechanical properties except fatigue strength. The connecting area always initiated fatigue failure. It is suggested that this area must be prevented for stress concentration. As a preliminary study, this study is fundamental for future studies.

Effects of ankle-foot orthoses on step activities in the community: a systematic review.

PURPOSE: To determine the effects of ankle-foot orthoses (AFO) on step-based physical activities in individuals with neurological, orthopaedic, or cardiovascular disorders. METHODS: Electronic searches of databases such as Scopus, PubMed, Web of Science, Embase, ProQuest, Cochrane Library, and EBSCO were conducted. Two evaluators independently searched with keywords focusing on step-based physical activities, and either articulated or non-articulated AFO. Study quality was assessed using a modified Downs and Black quality scale. RESULTS: Eleven studies that met the inclusion criteria were selected, including four being classified as good, four as fair, and three as poor in quality. The majority of these trials found no significant effects of AFO on step activities. Only a few studies reported improvements in step counts and active times in step activity with a limited to moderate level of evidence. Subjective evaluations such as user satisfaction, and physical functionality during step activity, on the other hand, showed substantial changes with the use of AFO interventions, although there was no evidence of improvement in the quality of life. CONCLUSIONS: Although the AFO did not seem to have a substantial effect on step activity, it appeared to play a vital role in improving the patient satisfaction level of step activity.IMPLICATIONS FOR REHABILITATIONAnkle-foot orthoses (AFO) may not significantly affect the step activity of individuals with impaired ankle-foot complex.AFO may enhance patient-reported satisfaction, physical functioning, participation, and fatigue level during step activity.The patient's perception that the AFO is beneficial is in contrast to objective data showing no significant increase in real-world activity.

Exploring the mechanical properties of 3D-printed multilayer lattice structures for use in accommodative insoles.

Full-contact insoles fabricated from multilayer foams are the standard of care (SoC) for offloading and redistributing high plantar pressures in individuals with diabetes at risk of plantar ulceration and subsequent lower limb amputation. These devices have regional variations in total thickness and layer thickness to create conformity with a patient's foot. Recent work has demonstrated that metamaterials can be tuned to match the mechanical properties of SoC insole foams. However, for devices fabricated using a multilayer lattice structure, having regional variations in total thickness and layer thickness may result in regional differences in mechanical properties that have yet to be investigated. Three lattices, two dual-layer and one uniform-layer lattice structure, designed to model the mechanical properties of SoC insoles, were 3D-printed at three structure/puck thicknesses representing typical regions seen in accommodative insoles. The pucks underwent cyclic compression testing, and the stiffness profiles were assessed. Three pucks at three structure/puck thicknesses fabricated from SoC foams were also tested. Initial evaluations suggested that for the latticed pucks, structure thickness and density inversely impacted puck stiffness. Behaving most like the SoC pucks, a dual-layer lattice that increased in density as structure thickness increased demonstrated consistent stiffness profiles across puck thicknesses. Identifying a lattice with constant mechanical properties at various structure thicknesses may be important to produce a conforming insole that emulates the standard of care from which patient-specific/regional lattice modulations can be made.

Individualized orthotic alignment and footwear for balance and mobility in children with bilateral spastic cerebral palsy: A randomized trial.

AIM: To examine whether designed-to-be-rigid ankle-foot orthoses and footwear combinations with individualized alignment and footwear designs (AFO-FC/IAFD) would be more effective than designed-to-be-rigid AFO with non-individualized alignment and footwear designs (AFO-FC/NAFD) in children with cerebral palsy (CP). METHOD: Nineteen children with bilateral spastic CP were randomized to AFO-FC/NAFD (n = 10) or AFO-FC/IAFD (n = 9) groups. Fifteen were male, average age 6 years 11 months (range 4 years 2 months-9 years 11 months), classified in Gross Motor Function Classification System levels II (n = 15) and III (n = 4). The Pediatric Balance Scale (PBS), Gait Outcomes Assessment List (GOAL), Patient-Reported Outcomes Measurement Information System (PROMIS), and Orthotic and Prosthetic Users' Survey (OPUS) measures of satisfaction were collected at baseline and after 3 months' wear. RESULTS: Compared with the AFO-FC/NAFD group, those with AFO-FC/IAFD demonstrated greater change in PBS total scores (mean 12.8 [standard deviation 10.5] vs 3.5 [5.8]; p = 0.03) and GOAL total scores (3.5 [5.8] vs -0.44 [5.5]; p = 0.03). There were no significant changes in OPUS or PROMIS scores. INTERPRETATION: After 3 months, individualized orthosis alignment and footwear designs had a greater positive effect on balance and parent-reported mobility than a non-individualized approach. No effect was documented for the PROMIS and OPUS. Results may inform orthotic management for ambulatory children with bilateral spastic CP. WHAT THIS PAPER ADDS: Balance and parent-reported mobility increased more over time for the ankle-foot orthoses and footwear combinations with individualized alignment and footwear designs (AFO-FC/IAFD) group. Changes in balance over time suggest a therapeutic effect of the AFO-FC/IAFD approach.

Effects of individually optimized rocker midsoles and self-adjusting insoles on plantar pressure in persons with diabetes mellitus and loss of protective sensation.

INTRODUCTION: Rocker shoes and insoles reduce peak pressure (PP) in persons with diabetes (DM) and loss of protective sensation (LOPS). However, they are handmade, leading to inconsistent effectiveness. If foot structure changes over time, high PP-locations also change. To address this, individualized algorithm based 3D-printed rockers and self-adjusting pressure-reducing insoles are applied. METHODS: PP across seven foot regions was analyzed in 21 persons with DM and LOPS. Regions with PP < 200 kPa were considered not at risk (RnoR); regions with PP ≥ 200 kPa at risk (RaR). The aim was to offload RaR, while remaining PP < 200 kPa in RnoR. RESULTS: Individualized rockers and self-adjusting insoles combined successfully reduce PP < 200 kPa (on average 24 % - 48 %) in all feet with toes, central and lateral forefoot identified as RaR. Same intervention reduces PP in 68 % of the feet with medial forefoot identified as RaR. With the heel as RaR, no intervention reduces PP successfully in all feet. CONCLUSIONS: Individualized 3D-printed rockers combined with self-adjusting insoles reduce PP (< 200 kPa) in toes, central and lateral forefoot, but not in heels. Alternative insoles with medial arch support, heel cup and compliant midsole materials might enhance success rate across entire foot.