Eficacia de plantillas y zapatos terapéuticos en la reducción de la incidencia de ulceración en pacientes con neuropatía diabética: una revisión sistemática con metaanálisis / Efficacy of insoles and therapeutic shoes in the reduction of the ulceration incidence in diabetic neuropathy patients: A Systematic Review with meta-analysis

Objetivo Investigar el nivel de eficacia de plantillas personalizadas y zapatos terapéuticos en la reducción de la presión plantar y la incidencia de ulceración en presencia de neuropatía diabética. Metodología Las bases de datos PubMed, Scopus, Web of Science, Cinahls, Central Cochrane y Lilacs fueron encuestados en enero de 2020. Se incluyeron ensayos clínicos aleatorizados (ECA) que reportaron pacientes con neuropatía diabética sometidos a intervención con plantillas y calzado terapéutico en comparación con un grupo control. La calidad de las publicaciones se evaluó mediante la escala PEDro y la evidencia mediante la clasificación GRADE. En cuanto al metaanálisis, se realizó la agrupación de datos homogéneos y comparables. Resultados Se incluyeron 11 estudios, lo que resultó en una muestra de 1.443 participantes. Siete artículos presentaron datos suficientes para el metaanálisis. En el corto plazo, el riesgo relativo de protección fue de 0,23 (IC 95%; 0,07; 0,72), mientras que en el largo plazo el riesgo fue de 0,32 (IC 95%; 0,21; 0,48). La escala GRADE señaló baja calidad de evidencia en cuanto a la protección a corto plazo y alta calidad a largo plazo En el análisis cualitativo, seis estudios concluyeron que hubo reducción en la presión plantar del grupo de intervención. Conclusión Se encontró efecto protector del uso de plantillas en el desarrollo de úlceras a corto y largo plazo. (AU)

Objective To investigate the level of efficacy of personalized insoles and therapeutical shoes in plantar pressure and ulceration incidence reduction in the presence of diabetic neuropathy. Methodology The data bases PubMed, Scopus, Web of Science, Cinahls, Central Cochrane and Lilacs were surveyed in January/2020. Randomized clinical trials (RCT) were included that reported diabetic neuropathy patients submitted to intervention with insoles and therapeutical shoes compared to a control group. The quality of the publications was evaluated using the PEDro scale and the evidence by the GRADE classification. Regarding the meta-analysis, the grouping of homogeneous and comparable data was carried out. Results Eleven studies were included, which resulted in a sample containing 1,443 participants. Seven papers presented enough data for the meta-analysis. In the short term, the protection relative risk was 0.23 (IC95% 0.07;0.72), while in the long term, the risk was 0.32 (IC95% 0.21;0.48). The GRADE scale pointed out low evidence quality regarding short-term protection and high quality in the long term. In the qualitative analysis, six studies concluded that there was reduction in the plantar pressure of the intervention group. Conclusion Protective effect of using insoles was found in the development of ulcers in the short and long term. (AU)

Eficacia de plantillas y zapatos terapéuticos en la reducción de la incidencia de ulceración en pacientes con neuropatía diabética: una revisión sistemática con metaanálisis / Efficacy of insoles and therapeutic shoes in the reduction of the ulceration incidence in diabetic neuropathy patients: A Systematic Review with meta-analysis

Objetivo Investigar el nivel de eficacia de plantillas personalizadas y zapatos terapéuticos en la reducción de la presión plantar y la incidencia de ulceración en presencia de neuropatía diabética. Metodología Las bases de datos PubMed, Scopus, Web of Science, Cinahls, Central Cochrane y Lilacs fueron encuestados en enero de 2020. Se incluyeron ensayos clínicos aleatorizados (ECA) que reportaron pacientes con neuropatía diabética sometidos a intervención con plantillas y calzado terapéutico en comparación con un grupo control. La calidad de las publicaciones se evaluó mediante la escala PEDro y la evidencia mediante la clasificación GRADE. En cuanto al metaanálisis, se realizó la agrupación de datos homogéneos y comparables. Resultados Se incluyeron 11 estudios, lo que resultó en una muestra de 1.443 participantes. Siete artículos presentaron datos suficientes para el metaanálisis. En el corto plazo, el riesgo relativo de protección fue de 0,23 (IC 95%; 0,07; 0,72), mientras que en el largo plazo el riesgo fue de 0,32 (IC 95%; 0,21; 0,48). La escala GRADE señaló baja calidad de evidencia en cuanto a la protección a corto plazo y alta calidad a largo plazo En el análisis cualitativo, seis estudios concluyeron que hubo reducción en la presión plantar del grupo de intervención. Conclusión Se encontró efecto protector del uso de plantillas en el desarrollo de úlceras a corto y largo plazo. (AU)

Objective To investigate the level of efficacy of personalized insoles and therapeutical shoes in plantar pressure and ulceration incidence reduction in the presence of diabetic neuropathy. Methodology The data bases PubMed, Scopus, Web of Science, Cinahls, Central Cochrane and Lilacs were surveyed in January/2020. Randomized clinical trials (RCT) were included that reported diabetic neuropathy patients submitted to intervention with insoles and therapeutical shoes compared to a control group. The quality of the publications was evaluated using the PEDro scale and the evidence by the GRADE classification. Regarding the meta-analysis, the grouping of homogeneous and comparable data was carried out. Results Eleven studies were included, which resulted in a sample containing 1,443 participants. Seven papers presented enough data for the meta-analysis. In the short term, the protection relative risk was 0.23 (IC95% 0.07;0.72), while in the long term, the risk was 0.32 (IC95% 0.21;0.48). The GRADE scale pointed out low evidence quality regarding short-term protection and high quality in the long term. In the qualitative analysis, six studies concluded that there was reduction in the plantar pressure of the intervention group. Conclusion Protective effect of using insoles was found in the development of ulcers in the short and long term. (AU)

Are the outcomes of relative motion extension orthoses non-inferior and cost-effective compared with dynamic extension orthoses for management of zones V-VI finger extensor tendon repairs: A randomized controlled trial.

INTRODUCTION: There is no comparative evidence for relative motion extension (RME) orthosis with dynamic wrist-hand-finger-orthosis (WHFO) management of zones V-VI extensor tendon repairs. PURPOSE OF THE STUDY: To determine if RME with wrist-hand-orthosis (RME plus) is noninferior to dynamic WHFO for these zones in clinical outcomes. STUDY DESIGN: Randomized controlled non-inferiority trial. METHODS: Skilled hand therapists managed 37 participants (95% male; mean age 39 years, SD 18) with repaired zones V-VI extensor tendons randomized to RME plus (n = 19) or dynamic WHFO (n = 18). The primary outcome of percentage of total active motion (%TAM) and secondary outcomes of satisfaction, function, and quality of life were measured at week-6 and -12 postoperatively; percentage grip strength (%Grip), complication rates, and cost data at week-12. Following the intention-to-treat principle non-inferiority was assessed using linear regression analysis (5% significance) and adjusted for injury complexity factors with an analysis of costs performed. RESULTS: RME plus was noninferior for %TAM at week-6 (adjusted estimates 2.5; 95% CI -9.0 to 14.0), %TAM at week-12 (0.3; -6.8 to 7.5), therapy satisfaction at week-6 and -12, and orthosis satisfaction, QuickDASH, and %Grip at week-12. Per protocol analysis yielded 2 tendon ruptures in the RME plus orthoses and 1 in the dynamic WHFO. There were no differences in health system and societal cost, or quality-adjusted life years. DISCUSSION: RME plus orthosis wearers had greater injury complexity than those in dynamic WHFOs, with overall rupture rate for both groups comparatively more than reported by others; however, percentage %TAM was comparable. The number of participants needed was underestimated, so risk of chance findings should be considered. CONCLUSIONS: RME plus management of finger zones V-VI extensor tendon repairs is non-inferior to dynamic WHFO in %TAM, therapy and orthotic satisfaction, QuickDASH, and %Grip. Major costs associated with this injury are related to lost work time.

Eficácia das palmilhas customizadas na melhora da distribuição da pressão plantar em pacientes com neuropatia diabética: Protocolo de um ensaio clínico randomizado e controlado / Efficacy of customized insoles in the improvement of plantar pressure in patients with diabetic neuropathy: Protocol of a randomized and controlled clinical trial

OBJETIVO: Avaliar a influência das palmilhas customizadas na pressão plantar de diabéticos com neuropatia em comparação ao grupo sham. MÉTODOS: O método do estudo, devidamente registrado no Registro Brasileiro de Ensaios Clínicos ­ REBEC (Clinical Trial Brazilian Register) (http://www.ensaiosclinicos.gov.br/) RBR-5NQK4K, incluiu um ensaio clínico randomizado, controlado, prospectivo, duplo-cego, com uma amostra de 46 voluntários que serão randomizados aleatoriamente numa razão de 1: 1 para serem direcionados aos grupos intervenção e controle. O grupo intervenção receberá palmilhas customizadas, com barra retrocapital e placa de etil vinil acetato (EVA) no mesmo formato da barra retrocapital, com a finalidade de reduzir a pressão no antepé. No grupo controle, as palmilhas planas serão confeccionadas sem nenhum objetivo terapêutico. Este projeto foi conduzido de acordo com o padrão de protocolo para ensaios clínicos randomizados (SPIRIT). Junto com a avaliação clínica, serão coletados dados demográficos da amostra para identificar e confirmar a presença de neuropatia periférica, em seguida, será avaliada a podobarografia e, por fim, os pacientes responderão ao questionário FAAM para avaliação da funcionalidade do pé. O desfecho primário será a análise dos pontos de pressão em KiloPascal (kPa) no pé dos pacientes com neuropatia diabética por meio da podobarografia nos pacientes do grupo intervenção e controle. O desfecho secundário será a funcionalidade do pé nas atividades de vida diária através do questionário FAAM (Foot and Ankle Ability Measure), considerando os voluntários na avaliação inicial, 3º e 6º meses. CONSIDERAÇÕES FINAIS: os futuros resultados deste estudo nos mostrarão principalmente se há ou não uma alteração estrutural na análise da pressão plantar decorrente do uso contínuo da palmilha, além de avaliar se o uso da palmilha terapêutica é eficaz na funcionalidade do pé nos mesmos portadores quando comparado à palmilha sham.

| OBJECTIVE: To evaluate the influence of customized insoles in the plantar pressure of diabetes patients with neuropathy in comparison to the sham group. METHODS: The work method, duly registered at the Registro Brasileiro de Ensaios Clínicos ­ REBEC (Clinical Trial Brazilian Register) (http://www.ensaiosclinicos.gov.br/) RBR-5NQK4K, includes a randomized, controlled, prospective, doubleblinded clinical trial, with a sample of 46 volunteers that will be randomly randomized in a 1: 1 ratio to be referred to intervention and control groups. The intervention group will receive customized insoles, with a retrocapital bar and an ethyl vinyl acetate plaque (EVA) in the same shape as the retrocapital bar, in order to reduce the pressure on the forefoot. In the control group, flat insoles will be prepared without any therapeutic objective. This project was developed according to the standard protocol for randomized clinical trials (SPIRIT). Along with the clinical evaluation, demographic data of the sample will be collected to identify and confirm the presence of peripheral neuropathy, next, the pedobarographic will be evaluated, and finally, the patients will answer the FAAM questionnaire to assess foot functionality. The primary outcome will be analyzing pressure points in KiloPascal (kPa) in the patients' feet through pedobarographic of the patients in the intervention and control groups. The secondary outcome will be the foot functionality in activities of daily living through the FAAM (Foot and Ankle Ability Measure), considering the volunteers in the initial evaluation, third and sixth months. FINAL CONSIDERATIONS: Mainly, results of this study will show whether there is a structural alteration in the analysis of the plantar pressure due to the continuous use of insoles and present the evaluation of whether the use of therapeutic insoles improves the foot functionality of the same users when compared to sham insoles.

Application of upper-limb dynamic pseudoelastic splinting in the treatment of stroke chronic patient: a pilot assessment.

PURPOSE: The chronic sequelae of stroke are often a strong limitation to patient's quality of life. New non-invasive elective treatments are required to support postural and functional improvements long after the primary insult. This study is an uncontrolled pilot evaluation of pseudoelastic orthotics for post-stroke upper-limb rehabilitation. MATERIALS AND METHODS: Six chronic hemiplegic patients (3.8 ± 1.7 years since stroke) were evaluated with clinical scales, covering the ICF domains of body functions and structures (Modified Ashworth Score [MAS], Medical Research Council Scale for Muscle Strength, Fugl-Meyer [FM], Motricity Index [MI]), activities (Wolf Motor Function Test [WMF], Motor Activity Log [MAL]) and participation (quality of life questionnaires); sensors applied to the orthosis were used to assess changes in the articular and functional domains over a month's treatment. RESULTS: Significant gains were achieved in elbow spasticity (MAS, p = .020), upper-limb motor function (FM, p = .005), reaching task (p = .035), and gait (p = .00046) speed. Most patients improved in functional tasks (WMF), but this did not reflect in daily-life activities as measured with MAL. Some patients reported an improved quality of life, especially the quality of sleep. CONCLUSIONS: Pseudoelastic orthoses could be a comfortable and useful adjunct in the long-term management of stroke. Broader trials will have to confirm these preliminary observations.Implications for rehabilitationUse of new materials in neuromuscular rehabilitation.Customised and adjustable therapeutic action obtained with dynamic personalised orthoses.Non-invasive interventions could be of help for patients with chronic disability.