Effect of an educational booklet for prevention and treatment of foot musculoskeletal dysfunctions in people with diabetic neuropathy: the FOotCAre (FOCA) trial II, a study protocol of a randomized controlled trial.

BACKGROUND: This study is a part of a series of two clinical trials. We consider diabetic polyneuropathy (DPN), a common chronic and progressive complication of diabetes mellitus that has several impacts on individuals' foot health and quality of life. Based on the current trends of self-monitoring and self-care, providing a tool with foot-related exercises and educational care may help patients to avoid or reduce the musculoskeletal complications resulting from DPN, improving autonomous performance in daily living tasks. The aim of this trial is to evaluate the effects of an educational booklet for foot care and foot muscle strengthening on DPN symptoms and severity, clinical outcomes, and gait biomechanics in patients with DPN. METHODS/DESIGN: The FOotCAre (FOCA) trial II study has been designed as a single-blind, two-parallel-arm randomized controlled trial. It will include 48 patients with DPN who will be randomly allocated to a control (recommended foot care by international consensus with no foot exercises) group or an intervention (foot-related exercises using an educational booklet three times/week at home for 8 weeks) group. Participants from both groups will be assessed at baseline, after 8 weeks, and at 16 weeks for follow-up. The primary outcomes are the DPN symptoms and severity, and the secondary outcomes are foot-ankle kinematics, gait kinetics, plantar pressure distribution during gait, tactile and vibratory sensitivities, foot strength, functional balance, and foot health and functionality. DISCUSSION: The booklet is a management tool that allows users to be autonomous in their treatment by choosing how and where to perform the exercises. This allows the patients to perform the exercises regularly as a continuous habit for foot care and health, which is an important element in the management of the diabetic foot. As the booklet focuses on specific foot-ankle exercises, we expect that it will improve the clinical aspects of DPN and produce beneficial biomechanical changes during gait, becoming a powerful self-management tool that can be easily implemented to improve the performance of daily living tasks. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04008745. Registered on 2 July 2019.

Study protocol for a randomized controlled trial on the effect of the Diabetic Foot Guidance System (SOPeD) for the prevention and treatment of foot musculoskeletal dysfunctions in people with diabetic neuropathy: the FOotCAre (FOCA) trial I.

BACKGROUND: This study is part of a series of two clinical trials. Taking into account the various musculoskeletal alterations of the foot and ankle in people with diabetic peripheral neuropathy (DPN) and the need for self-care to avoid more serious dysfunctions and complications, a self-manageable exercise protocol that focuses on strengthening the foot muscles is presented as a potentially effective preventive method for foot and gait complications. The aim of this trial is to investigate the effect of a customized rehabilitation technology, the Diabetic Foot Guidance System (SOPeD), on DPN status, functional outcomes and gait biomechanics in people with DPN. METHODS/DESIGN: Footcare (FOCA) trial I is a randomized, controlled and parallel two-arm trial with blind assessment. A total of 62 patients with DPN will be allocated into either a control group (recommended foot care by international consensus with no foot exercises) or an intervention group (who will perform exercises through SOPeD at home three times a week for 12 weeks). The exercise program will be customized throughout its course by a perceived effort scale reported by the participant after completion of each exercise. The participants will be assessed at three different times (baseline, completion at 12 weeks, and follow-up at 24 weeks) for all outcomes. The primary outcomes will be DPN symptoms and severity classification. The secondary outcomes will be foot-ankle kinematics and kinetic and plantar pressure distribution during gait, tactile and vibration sensitivities, foot health and functionality, foot strength, and functional balance. DISCUSSION: As there is no evidence about the efficacy of rehabilitation technology in reducing DPN symptoms and severity or improving biomechanical, clinical, and functional outcomes for people with DPN, this research can contribute substantially to clarifying the therapeutic merits of software interventions. We hope that the use of our application for people with DPN complications will reduce or attenuate the deficits caused by DPN. This rehabilitation technology is freely available, and we intend to introduce it into the public health system in Brazil after demonstrating its effectiveness. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04011267. Registered on 8 July 2019.

Decreased muscle strength is associated with proinflammatory cytokines but not testosterone levels in men with diabetes.

The aim of this study was to compare muscle strength in male subjects with type 2 diabetes mellitus (DM2) with and without low plasma testosterone levels and assess the relationship between muscle strength, testosterone levels, and proinflammatory cytokines. Males (75) aged between 18 and 65 years were divided into 3 groups: control group that did not have diabetes and had a normal testosterone plasma level (>250 ng/dL), DnormalTT group that had DM2 with normal testosterone levels, and the DlowTT group that had DM2 and low plasma testosterone levels (<250 ng/dL). The age (means±SD) of the groups was 48.4±10, 52.6±7, and 54.6±7 years, respectively. Isokinetic concentric and isometric torque of knee flexors and extensors were analyzed by an isokinetic dynamometer. Plasma testosterone and proinflammatory cytokine levels were determined by chemiluminescence and ELISA, respectively. Glycemic control was analyzed by glycated hemoglobin (HbA1C). In general, concentric and isometric torques were lower and tumor necrosis factor (TNF)-α, interleukin (IL)-6, and IL-1ß plasma levels were higher in the groups with diabetes than in controls. There was no correlation between testosterone level and knee torques or proinflammatory cytokines. Concentric and isometric knee flexion and extension torque were negatively correlated with TNF-α, IL-6, and HbA1C. IL-6 and TNF-α were positively correlated with HbA1C. The results of this study demonstrated that muscle strength was not associated with testosterone levels in men with DM2. Low muscle strength was associated with inflammatory markers and poor glycemic control.

Decreased muscle strength is associated with proinflammatory cytokines but not testosterone levels in men with diabetes

The aim of this study was to compare muscle strength in male subjects with type 2 diabetes mellitus (DM2) with and without low plasma testosterone levels and assess the relationship between muscle strength, testosterone levels, and proinflammatory cytokines. Males (75) aged between 18 and 65 years were divided into 3 groups: control group that did not have diabetes and had a normal testosterone plasma level (>250 ng/dL), DnormalTT group that had DM2 with normal testosterone levels, and the DlowTT group that had DM2 and low plasma testosterone levels (<250 ng/dL). The age (means±SD) of the groups was 48.4±10, 52.6±7, and 54.6±7 years, respectively. Isokinetic concentric and isometric torque of knee flexors and extensors were analyzed by an isokinetic dynamometer. Plasma testosterone and proinflammatory cytokine levels were determined by chemiluminescence and ELISA, respectively. Glycemic control was analyzed by glycated hemoglobin (HbA1C). In general, concentric and isometric torques were lower and tumor necrosis factor (TNF)-α, interleukin (IL)-6, and IL-1β plasma levels were higher in the groups with diabetes than in controls. There was no correlation between testosterone level and knee torques or proinflammatory cytokines. Concentric and isometric knee flexion and extension torque were negatively correlated with TNF-α, IL-6, and HbA1C. IL-6 and TNF-α were positively correlated with HbA1C. The results of this study demonstrated that muscle strength was not associated with testosterone levels in men with DM2. Low muscle strength was associated with inflammatory markers and poor glycemic control.

Effect of image resolution manipulation in rearfoot angle measurements obtained with photogrammetry

The aim of this study was to investigate the influence of image resolution manipulation on the photogrammetric measurement of the rearfoot static angle. The study design was that of a reliability study. We evaluated 19 healthy young adults (11 females and 8 males). The photographs were taken at 1536 pixels in the greatest dimension, resized into four different resolutions (1200, 768, 600, 384 pixels) and analyzed by three equally trained examiners on a 96-pixels per inch (ppi) screen. An experienced physiotherapist marked the anatomic landmarks of rearfoot static angles on two occasions within a 1-week interval. Three different examiners had marked angles on digital pictures. The systematic error and the smallest detectable difference were calculated from the angle values between the image resolutions and times of evaluation. Different resolutions were compared by analysis of variance. Inter- and intra-examiner reliability was calculated by intra-class correlation coefficients (ICC). The rearfoot static angles obtained by the examiners in each resolution were not different (P > 0.05); however, the higher the image resolution the better the inter-examiner reliability. The intra-examiner reliability (within a 1-week interval) was considered to be unacceptable for all image resolutions (ICC range: 0.08-0.52). The whole body image of an adult with a minimum size of 768 pixels analyzed on a 96-ppi screen can provide very good inter-examiner reliability for photogrammetric measurements of rearfoot static angles (ICC range: 0.85-0.92), although the intra-examiner reliability within each resolution was not acceptable. Therefore, this method is not a proper tool for follow-up evaluations of patients within a therapeutic protocol.

Effect of image resolution manipulation in rearfoot angle measurements obtained with photogrammetry.

The aim of this study was to investigate the influence of image resolution manipulation on the photogrammetric measurement of the rearfoot static angle. The study design was that of a reliability study. We evaluated 19 healthy young adults (11 females and 8 males). The photographs were taken at 1536 pixels in the greatest dimension, resized into four different resolutions (1200, 768, 600, 384 pixels) and analyzed by three equally trained examiners on a 96-pixels per inch (ppi) screen. An experienced physiotherapist marked the anatomic landmarks of rearfoot static angles on two occasions within a 1-week interval. Three different examiners had marked angles on digital pictures. The systematic error and the smallest detectable difference were calculated from the angle values between the image resolutions and times of evaluation. Different resolutions were compared by analysis of variance. Inter- and intra-examiner reliability was calculated by intra-class correlation coefficients (ICC). The rearfoot static angles obtained by the examiners in each resolution were not different (P > 0.05); however, the higher the image resolution the better the inter-examiner reliability. The intra-examiner reliability (within a 1-week interval) was considered to be unacceptable for all image resolutions (ICC range: 0.08-0.52). The whole body image of an adult with a minimum size of 768 pixels analyzed on a 96-ppi screen can provide very good inter-examiner reliability for photogrammetric measurements of rearfoot static angles (ICC range: 0.85-0.92), although the intra-examiner reliability within each resolution was not acceptable. Therefore, this method is not a proper tool for follow-up evaluations of patients within a therapeutic protocol.

Avaliação das perdas sensório-motoras do pé e tornozelo decorrentes da neuropatia diabética / Assessment of motor sensory losses in the foot and ankle due to diabetic neuropathy

OBJETIVOS: Identificar déficits sensório-motores de pés de pacientes diabéticos neuropatas e comparar os déficits do grupo neuropata com um grupo de sujeitos saudáveis. MÉTODO: 49 diabéticos neuropatas (GD) e 22 controles foram submetidos a um protocolo de três estágios: (1) entrevista por meio de questionário, que caracterizou a neuropatia e sintomas, (2) avaliação da função muscular, amplitude de movimentos e testes funcionais dos pés e tornozelos, (3) avaliação da sensibilidade tátil e térmica. Os grupos foram comparados por meio dos testes Qui-quadrado, Mann-Withney e Teste T (p<0,05). RESULTADOS: O GD mostrou perda significativa das sensibilidades tátil e térmica em comparação ao grupo controle, principalmente nos calcanhares (49,0 por cento no GD e 97,3 por cento no GC). A função muscular está diminuída no GD, com predomínio da perda do grau 5. Os músculos mais afetados são os interósseos (23,4 por cento), extensor do hálux (42,5 por cento) e tríceps sural (43,2 por cento), enquanto que o GC teve todos os músculos preservados. Todas as ADMs do GD estão diminuídas em relação ao GC. O GD apresentou os testes funcionais de tornozelo diminuídos em 50 por cento. CONCLUSÃO: Houve diferenças significativas entre os grupos quanto às perdas sensitivas, de função muscular, amplitude de movimento e funcionais. Essas diferenças podem ser atribuídas à neuropatia diabética.

OBJECTIVE: To identify motor sensory deficits in the feet of neuropathic diabetic patients and compare their deficits with a group of healthy subjects. METHOD: 49 neuropathic diabetics (group NG) and 22 controls (group CG) underwent a three-stage protocol: (1) an interview using a questionnaire to characterize the neuropathy and symptoms; (2) assessment of muscle function and range of motion, and functional tests on the feet and ankles; (3) assessment of tactile and thermal sensitivity. The groups were compared using the chi-squared, Mann-Whitney and Student t tests (p<0.05). RESULTS: NG presented significant losses of tactile and thermal sensitivity in comparison with CG, especially in the heels (49.0 percent of NG and 97.3 percent of CG). Muscle function was decreased in NG, with predominance of loss of grade 5. The muscles most affected were the interossei (23.4 percent), extensor hallucis (42.5 percent) and triceps surae (43.2 percent), while all muscle function was preserved in CG. All ranges of motion in NG were reduced in comparison with CG. The functional tests on the ankles in NG presented a decrease of around 50 percent. CONCLUSION: There were significant differences between the groups with regard to sensitivity, muscle function, range of motion and functional losses. These differences can be attributed to the diabetic neuropathy.