RESUMO
This study sought to assess the feasibility of design, adherence, satisfaction, safety and changes in outcomes followed by a home-based foot-ankle exercise guided by a booklet in individuals with diabetic peripheral neuropathy (DPN). 20 participants were allocated usual care [control group (CG)] or usual care plus home-based foot-ankle exercises [intervention group (IG)] for 8 weeks. For feasibility, we assessed contact, preliminary screening and recruitment rates, adherence, and using a 5-point Likert scale to satisfaction and safety of the booklet. In the IG, we assessed preliminary changes in DPN symptoms, DPN severity (classified by a fuzzy model) and foot-ankle range of motion between baseline and Week 8. In the first 20 weeks, 1310 individuals were screened for eligibility by phone contact. Contact rate was 89% (contacted participants/20w), preliminary screening success 28% (participants underwent screening/20w), and recruitment rate 1.0 participants/week (eligible participants/20w). The recruitment rate was less than the ideal rate of 5 participants/week. The adherence to the exercises programme was 77%, and the dropout was 11% and 9% for the IG and CG, respectively. In the IG, participants' median level of satisfaction was 4 (IQR: 4-5) and perceived safety was 3 (IQR: 3-5). IG significantly decreased the DPN severity (p = 0.020), increased hallux relative to forefoot (first metatarsal) range of motion (ROM) (p < 0.001) and decreased maximum forefoot relative to hindfoot (midfoot motion) dorsiflexion during gait (p = 0.029). The home-based programme was feasible, satisfactory, safe and showed preliminary positive changes in DPN severity and foot motion during gait.Trial Registration ClinicalTrials.gov, NCT04008745. Registered 02/07/2019. https://clinicaltrials.gov/ct2/show/NCT04008745 .
Assuntos
Tornozelo/fisiopatologia , Neuropatias Diabéticas/reabilitação , Exercício Físico , Pé/fisiopatologia , Serviços de Assistência Domiciliar , Doenças Musculoesqueléticas/fisiopatologia , Modalidades de Fisioterapia , Fenômenos Biomecânicos , Estudos de Viabilidade , Marcha , Humanos , Doenças Musculoesqueléticas/reabilitação , Cooperação do Paciente , Método Simples-CegoRESUMO
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.
Assuntos
Diabetes Mellitus Tipo 2/complicações , Neuropatias Diabéticas/reabilitação , Pé/fisiopatologia , Educação de Pacientes como Assunto/métodos , Autocuidado/métodos , Atividades Cotidianas , Adolescente , Adulto , Idoso , Neuropatias Diabéticas/diagnóstico , Neuropatias Diabéticas/etiologia , Neuropatias Diabéticas/fisiopatologia , Exercício Físico/fisiologia , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Força Muscular/fisiologia , Músculo Esquelético/fisiopatologia , Folhetos , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Índice de Gravidade de Doença , Método Simples-Cego , Resultado do Tratamento , Adulto JovemRESUMO
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.
Assuntos
Pé Diabético/prevenção & controle , Neuropatias Diabéticas/reabilitação , Terapia por Exercício , Pé/inervação , Autocuidado , Adolescente , Adulto , Idoso , Fenômenos Biomecânicos , Brasil , Pé Diabético/diagnóstico , Pé Diabético/fisiopatologia , Neuropatias Diabéticas/diagnóstico , Neuropatias Diabéticas/fisiopatologia , Estudos de Equivalência como Asunto , Feminino , Marcha , Humanos , Masculino , Pessoa de Meia-Idade , Força Muscular , Método Simples-Cego , Fatores de Tempo , Resultado do Tratamento , Adulto JovemRESUMO
Diabetic polyneuropathy is an insidious and long-term complication of this disease. Synergistic treatments and preventive actions are crucial because there are no clear boundaries for determining when health professionals should intervene or what intervention would best avoid the consequences of neuropathy. Until now, most therapies to any diabetic individual were applied only after the patient's limb was ulcerated or amputated. The loss of muscle and joint functions is recognized as the main cause of plantar overloading. However, if foot and ankle exercises are performed following the early diagnosis of diabetes, they can enable the patient to maintain sufficient residual function to interact with the environment. This article summarizes the current knowledge about the musculoskeletal deficits and biomechanical alterations caused by neuropathy. It also describes the potential benefits of foot and ankle exercises for any diabetic patient that is not undergoing the plantar ulcer healing process. We concentrate on the prevention of the long-term deficits of neuropathy. We also discuss the main strategies and protocols of therapeutic exercises for joints and muscles with deficits, which are applicable to all diabetic patients with mild to moderate neuropathy. We describe further efforts in exploiting the applicability of assistive technologies to improve the adherence to an exercise program. Following the contemporary trends towards self-monitoring and self-care, we developed a software to monitor and promote personalized exercises with the aim of improving autonomous performance in daily living tasks. Initiatives to prevent the complications of functional diabetes are highly recommended before it is too late for the patient and there is no longer an opportunity to reverse the tragic consequences of neuropathy progression.
Assuntos
Pé Diabético/prevenção & controle , Neuropatias Diabéticas/terapia , Medicina Baseada em Evidências , Terapia por Exercício , Saúde Global , Polineuropatias/terapia , Medicina de Precisão , Terapia Combinada , Congressos como Assunto , Pé Diabético/fisiopatologia , Pé Diabético/reabilitação , Pé Diabético/terapia , Neuropatias Diabéticas/diagnóstico , Neuropatias Diabéticas/fisiopatologia , Neuropatias Diabéticas/reabilitação , Progressão da Doença , Diagnóstico Precoce , Humanos , Cooperação do Paciente , Polineuropatias/diagnóstico , Polineuropatias/fisiopatologia , Polineuropatias/reabilitação , Tecnologia Assistiva , Índice de Gravidade de Doença , Suporte de Carga , CicatrizaçãoRESUMO
INTRODUCTION: In this study we evaluate the effects of exercise training (10 weeks) on soleus muscle morphology in diabetic nerve regeneration after injury by sciatic nerve crush. METHODS: Wistar rats were assigned to either a non-diabetic (n = 6), non-diabetic injured (n = 6), diabetic (n = 6), diabetic injured (DC; n = 9), or trained diabetic injured group (TDC; n = 7). Muscle transverse sections were used for morphometric and ultrastructural analyses. RESULTS: Higher fiber density and smaller average myofiber area were observed in the DC and TDC (P < 0.05) groups compared with the other groups. This atrophic pattern was partially reversed in TDC. There was misalignment of the sarcomeres and structural alterations in the blood vessels, sarcolemma, nucleus, and mitochondria in the DC animals. The myofibers and blood vessels had a similar normal appearance in the TDC group. In addition, polyribosomes, rough sarcoplasmic reticulum, developed Golgi apparatus, and new myofibrils were observed. CONCLUSIONS: Sciatic nerve injury was found to promote soleus muscle atrophy and ultrastructural alterations in experimental diabetic nerve regeneration, which were partially reversed by exercise training.
Assuntos
Neuropatias Diabéticas , Músculo Esquelético/patologia , Regeneração Nervosa/fisiologia , Condicionamento Físico Animal/métodos , Análise de Variância , Animais , Vasos Sanguíneos/patologia , Vasos Sanguíneos/ultraestrutura , Peso Corporal , Neuropatias Diabéticas/patologia , Neuropatias Diabéticas/fisiopatologia , Neuropatias Diabéticas/reabilitação , Modelos Animais de Doenças , Teste de Esforço/métodos , Jejum/fisiologia , Índice Glicêmico , Masculino , Microscopia Eletrônica de Transmissão , Músculo Esquelético/ultraestrutura , Compressão Nervosa/métodos , Ratos , Ratos Wistar , Nervo Isquiático/lesões , Nervo Isquiático/fisiopatologiaRESUMO
BACKGROUND AND AIMS: We undertook this study to assess the influence of diabetic peripheral neuropathy on self-reported disability and postural control during quiet stance of patients with peripheral vestibular disease, before and after a standardized program of vestibular rehabilitation (Cawthorne & Cooksey exercises). METHODS: Twenty patients with peripheral vestibular disease participated in the study (mean age 56+/-7.8 years), 10 with and 10 without peripheral neuropathy (age matched). The Dizziness Handicap Inventory and static posturography (eyes open/closed and firm/soft surface) were evaluated prior to rehabilitation and at week 7 of follow-up. RESULTS: Compared to patients without neuropathy, patients with neuropathy had more time elapsed since the diabetes was diagnosed, higher glycemia and HbAc level and higher composite scores on the Dizziness Handicap Inventory, but similar results on static posturography. After rehabilitation, although scores on the Dizziness Handicap Inventory decreased in the two groups, the difference between them persisted. In patients with neuropathy, static posturography showed improvement of postural control only with the eyes closed and soft surface, whereas in patients without neuropathy the postural control improved during all sensory conditions (eyes open/closed and firm/soft surface). CONCLUSIONS: In diabetic patients with peripheral vestibular disease, peripheral neuropathy contributes to self-reported disability and may interfere with complete balance recovery.
Assuntos
Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/fisiopatologia , Neuropatias Diabéticas/fisiopatologia , Equilíbrio Postural , Doenças Vestibulares/fisiopatologia , Neuropatias Diabéticas/complicações , Neuropatias Diabéticas/reabilitação , Tontura/etiologia , Tontura/fisiopatologia , Tontura/reabilitação , Feminino , Humanos , Pessoa de Meia-Idade , Inquéritos e Questionários , Doenças Vestibulares/complicações , Doenças Vestibulares/reabilitaçãoRESUMO
O objetivo foi elaborar e aplicar um tratamento fisioterapêutico para diabéticos neuropatas e comparar suas respostas sensoriais, motoras e funcionais pré e pós-intervenção, com um grupo de sujeitos não diabéticos assintomáticos...
The purpose of this study was to elaborate an apply a physical therapy treatment for diabetic neuropathic patients, comparing the sensorial, motor an functional responses before and after treatment to those of a healthy control group. Ten healthy subjetcs (CG) and 10 neuropathic diabetes patients...
Assuntos
Humanos , Masculino , Feminino , Neuropatias Diabéticas/reabilitação , Modalidades de Fisioterapia , Amplitude de Movimento ArticularRESUMO
CONTEXT AND OBJECTIVE: Physiotherapy can contribute towards recovering or preventing physical and sensory alterations in diabetic neuropathy patients. Our objective was to create and apply a protocol for functional assessment of diabetic neuropathy patients' lower limbs, to guide future physiotherapy. DESIGN AND SETTING: Clinical study at the University Hospital and teaching/research center of Universidade de São Paulo. METHODS: An intentional sample of diabetic neuropathy patients was utilized. The protocol was divided into: (1) preliminary investigation with identification of relevant clinical diabetes and neuropathy characteristics; (2) thermal, tactile and proprioceptive sensitivity tests on the feet; (3) evaluations of muscle function, range of motion, lower limb function, foot anthropometry. RESULTS: The patients' mean age was 57 years, and they had had the diagnosis for 13 years on average. Distal numbness and tingling/prickling were present in 62% and 67%, respectively. There were tactile sensitivity alterations above the heel in 50%, with thermal sensitivity in 40% to 60%. The worst muscle function test responses were at the triceps surae and foot intrinsic muscles. Longitudinal plantar arches were lowered in 50%. Decreased thermal and tactile sensitivity of the heels was found. There was a general reduction in range of motion. CONCLUSIONS: The results provided detailed characterization of the patients. This protocol may be easily applied in healthcare services, since it requires little equipment, at low cost, and it is well understood by patients.
Assuntos
Neuropatias Diabéticas/diagnóstico , Músculo Esquelético/fisiopatologia , Exame Neurológico/métodos , Distúrbios Somatossensoriais/diagnóstico , Adulto , Brasil , Protocolos Clínicos , Pé Diabético/diagnóstico , Pé Diabético/prevenção & controle , Neuropatias Diabéticas/complicações , Neuropatias Diabéticas/reabilitação , Feminino , Hospitais Universitários , Humanos , Masculino , Pessoa de Meia-Idade , Reprodutibilidade dos Testes , Distúrbios Somatossensoriais/etiologia , Distúrbios Somatossensoriais/reabilitaçãoRESUMO
CONTEXTO E OBJETIVO: A fisioterapia pode contribuir na recuperação e prevenção nas alterações sensoriais e motoras em pacientes com neuropatia diabética (ND). Este protocolo foi criado e aplicado em diabéticos neuropatas clinicamente diagnosticados, com o objetivo de se avaliar funcionalmente membros inferiores (MMII), para futura indicação de tratamento fisioterapêutico. TIPO DE ESTUDO E LOCAL: Estudo clínico no Hospital Universitário e Centro de Docência e Pesquisa, Universidade de São Paulo.MÉTODOS: Amostragem intencional de diabéticos neuropatas foi utilizada. Protocolo: (1) investigação inicial: identificação de características clínicas relevantes da diabetes e da neuropatia; (2) testes de função muscular, amplitudes articulares, funcionalidade de MMII, antropometria dos pés; (3) avaliação das sensibilidades térmica, tátil e proprioceptiva dos pés. RESULTADOS: A média das idades dos pacientes foi de 57 anos, e eles apresentavam um tempo médio de diagnóstico clínico de diabetes de 13 anos. Adormecimento e agulhadas/formigamento estavam presentes em 62% e 67%, respectivamente. Alterações da sensibilidade tátil nos calcanhares foram percebidas em 50% dos pacientes, e da térmica, em 40% a 60%. As piores respostas dos testes de função muscular foram obtidas nos músculos tríceps sural e intrínsecos do pé. Os arcos longitudinais plantares estavam rebaixados em 50% dos pacientes. Houve redução geral nas amplitudes articulares. CONCLUSÕES: Os resultados possibilitam a caracterização dos pacientes avaliados. Este protocolo pode ser facilmente aplicado nos serviços de saúde, pois requer poucos equipamentos, é de baixo custo e é de fácil entendimento para os pacientes.
Assuntos
Humanos , Masculino , Feminino , Adulto , Pessoa de Meia-Idade , Distúrbios Somatossensoriais , Exame Neurológico/métodos , Músculo Esquelético/fisiopatologia , Neuropatias Diabéticas/diagnóstico , Distúrbios Somatossensoriais , Brasil , Hospitais Universitários , Neuropatias Diabéticas/complicações , Neuropatias Diabéticas/reabilitação , Protocolos Clínicos , Pé Diabético/diagnóstico , Pé Diabético/prevenção & controle , Reprodutibilidade dos TestesRESUMO
The Semmes- Weisnstein pressure aesthesiometer, which measures cutaneous pressure sensation,was used for quantifying sensory loss in diabetic peripheral neuropathy...