Effect of Plantar Vibration on Static and Dynamic Balance
30 de junho de 2021 atualizado por: Birol Önal, Kırıkkale University
Effect of Plantar Vibration on the Static and Dynamic Balance in Stroke Patients
The aim of this study is to have a positive effect on the static and dynamic balance of vibration applied to the foot base in stroke patients.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
Kırıkkale University Faculty of Medicine Physical Therapy will be hospitalized in the USA clinic and volunteers will be involved in stroke rehabilitation.
The patients who meet the inclusion criteria and who are excluded from the exclusion criteria will be randomized according to the order of arrival and will be divided into two groups as the education group and the control group.
Patients will be taken to the control and study group respectively in order of arrival.
If the next patient falls outside the inclusion criteria of the study, randomization will be applied to the next patient.
Patients in the control group will be given routine conventional physiotherapy in 4-week and 60-minute sessions.
The training group will be given routine conventional physiotherapy in 4-week and 45-minute sessions.In addition, three sessions a week will be applied to the soles of the feet for 15 minutes with a 15-100 Hz vibration device on both sides of the soles of the feet before conventional physical therapy.
Individuals before; age, gender, marital status, nutritional characteristics, habits, smoking and alcohol, auxiliary devices, background information, family history, educational status, social security, previous or current occupation, frequency of fall, cause of fall and drugs used will be questioned.
Static and dynamic equilibrium parameters will be evaluated at the beginning of the study and at the end of the 4th week.
Tipo de estudo
Intervencional
Inscrição (Real)
30
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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-
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Kırıkkale, Peru, 71000
- Kırıkkale University
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
45 anos a 70 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- 45-70 years of age stroke areas
- Cognitive and non-communication problems
- Volunteer to join the work
- Those with less than 150 kilos
- Can walk 10 meters independently (with assistive device if available)
- Patients with a maximum level of 2-3 spasticity according to the Modified Ashworth Scale
- Patients at least 8 weeks after stroke diagnosis
Exclusion Criteria:
- People who are not stable due to vital signs
- Those with coronary heart disease
- Open wounds under the soles of the feet
- Being spastic at the level that will block the base touch
- Pathological conditions affecting lower limb sense (diabetic peripheral neuropathy, post- fracture surgery)
- 20 seconds independent standing
- Mini Mental Test score below 24
- Multiple sclerosis, Parkinson's disease, etc.
- Those with vision problems
- Patients with thoracolumbar surgery
- Patients with spinal canal stenosis
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Plantar Vibration Group
Patients in plantar vibration group will be received 45-minute conventional physiotherapy session for 5-days in a week, over 4-week.
Each physiotherapy sessions will consist of range of motion exercises, strengthening exercises, exercises such as activities of daily living, mobility and transfer activities.
In addition, three sessions a week will be applied to the soles of the feet for 15 minutes with a 15-100 Hz vibration device on both sides of the soles of the feet before conventional physical therapy.
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Patients in plantar vibration group will be received 45-minute conventional physiotherapy session for 5-days in a week, over 4-week.
Each physiotherapy sessions will consist of range of motion exercises, strengthening exercises, exercises such as activities of daily living, mobility and transfer activities.
In addition, three sessions a week will be applied to the soles of the feet for 15 minutes with a 15-100 Hz vibration device on both sides of the soles of the feet before conventional physical therapy.
|
|
Comparador Ativo: Control Group
Patients in the control group will be received 60-minute conventional pysiotherapy session for 5-days in a week, over 4-week.
Each physiotherapy session will consist of range of motion exercises, strengthening exercises, exercises such as activities of daily living, mobility and transfer activities.
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Patients in control group will be received 60-minute conventional physiotherapy session for 5-days in a week, over 4-week.
Each physiotherapy sessions will consist of range of motion exercises, strengthening exercises, exercises such as activities of daily living, mobility and transfer activities.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Mini-Mental State Test
Prazo: 15 minute
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It was used to determine the cognitive state before the training.
The Mini-Mental State Test was first published by Folstein et al.
It consists of eleven items under 5 main headings: orientation, record memory, attention and calculation, recall and language, and the total score is evaluated over 30 points.
The ideal threshold value of the Mini-Mental State Test was found to be 24.
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15 minute
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Time Up and Go Test
Prazo: 5 minute
|
This test is applied to assess the risk of falling and mobility.This test starts with the individual leaving the chair without receiving arm support by giving the go command while sitting in a chair.The distance of 3 meters is asked to return and sit again in the chair.The elapsed time is recorded in seconds.
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5 minute
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Berg Balance Scale
Prazo: 15 minute
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It is a 14-item scale that evaluates the tasks used in daily life activities.Standing up without support, standing without support, sitting without support, standing up, transfers, standing with feet, standing with legs while standing, reaching out while standing, picking up from the ground, looking back, 360 degree rotation, firm side standing on the stool, one foot standstill and standstill functions are evaluated.Each item is planned between 0-4; 0 is unable to fulfill the task, 4 is to fulfill the task successfully.
The total score of the test is between 0-56.0-20
points: wheelchair dependent, 21-40: assisted walking, 41-56: means independent ambulation.
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15 minute
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Trunk Impairment Scale
Prazo: 10 minute
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Evaluate the motor loss in trunk after stroke.It is a scale consisting of 17 items.3
items assess the static sitting balance, dynamic balance with 10 items, coordination with 4 items.The score is 0-23.The highest score is considered the best performance.
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10 minute
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Functional Reach Test
Prazo: 5 minute
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Subjects will asked to stand comfortably, to make a fist, and to raise their arm until it was parallel to the yardstick (position 1).
The placement of the end of the third metacarpal along the yardstick will recorded.
Subjects will then asked to reach as far forward as they could without losing their balance (position 2), and the position of the end of the third metacarpal along the yardstick will again recorded.
No attempt will make to control the subject's method of reach, but if he will touch the wall or took a step during the maneuver, that trial will consider invalid and repeated.
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5 minute
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10 Meter Walk Tests
Prazo: 3 minute
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Walking speed are measure by timing subjects over 10 meters with a stopwatch.
To avoid the effects of acceleration and deceleration, measurements take over the middle 10 meters of a 14-meter walkway.
It is repeated 2 times.
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3 minute
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Birol Onal, Kırıkkale University
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Khalifeloo M, Naghdi S, Ansari NN, Akbari M, Jalaie S, Jannat D, Hasson S. A study on the immediate effects of plantar vibration on balance dysfunction in patients with stroke. J Exerc Rehabil. 2018 Apr 26;14(2):259-266. doi: 10.12965/jer.1836044.022. eCollection 2018 Apr.
- Paoloni M, Mangone M, Scettri P, Procaccianti R, Cometa A, Santilli V. Segmental muscle vibration improves walking in chronic stroke patients with foot drop: a randomized controlled trial. Neurorehabil Neural Repair. 2010 Mar-Apr;24(3):254-62. doi: 10.1177/1545968309349940. Epub 2009 Oct 23.
- Wanderley FS, Alburquerque-Sendin F, Parizotto NA, Rebelatto JR. Effect of plantar vibration stimuli on the balance of older women: a randomized controlled trial. Arch Phys Med Rehabil. 2011 Feb;92(2):199-206. doi: 10.1016/j.apmr.2010.10.014.
- Onal B, Sertel M, Karaca G. Effect of plantar vibration on static and dynamic balance in stroke patients: a randomised controlled study. Physiotherapy. 2022 Sep;116:1-8. doi: 10.1016/j.physio.2022.02.002. Epub 2022 Feb 14.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
26 de dezembro de 2018
Conclusão Primária (Real)
20 de junho de 2019
Conclusão do estudo (Real)
25 de julho de 2019
Datas de inscrição no estudo
Enviado pela primeira vez
18 de dezembro de 2018
Enviado pela primeira vez que atendeu aos critérios de CQ
20 de dezembro de 2018
Primeira postagem (Real)
24 de dezembro de 2018
Atualizações de registro de estudo
Última Atualização Postada (Real)
2 de julho de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
30 de junho de 2021
Última verificação
1 de junho de 2021
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- strokeandvibration
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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