- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT05331092
Efeitos da crioterapia na função do tornozelo
Efeitos da crioterapia na função do tornozelo: ensaio clínico randomizado
The ankle joint is commonly used and also stricken by high loads and injuries in sports. One technique in emphasis is cryotherapy, a physiotherapeutical intervention characterized by the use of low temperatures for tissue trauma's rehabilitation. Several studies analysed the effects of cryotherapy and brought important results related to pain and strength reduction, also to muscle contraction speed reduction. Although, considering the risk-benefit from de intervention it's pertinent to observe the presence of deleterious effects, especially the ones that impact on motor function. This scenario has been brought by scientists and currently the main gap from this theme resides on the repercussions of the technique application on functional answers
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Eighty participants will receive control (rest) and the experimental condition (cryotherapy), with an interval of 48 hours. The intervention group will undergo: i) assessment, ii) 20 minutes of cryotherapy, iii) reassessment, iv) 20 minutes of rest and v) reassessment, while the control group remains at rest for 20 minutes. Assessments will be composed of ankle function by the modified star excursion balance test, muscle tone by the myoton pro, skin temperature by a thermographic camera, thermic comfort, perception of balance and beliefs in cryotherapy. Data will be described using mean and standard deviation and compared by Mixed ANOVA (time x intervention) with post Bonferroni tests, with significance level of 0.05.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
São Paulo
-
Presidente Prudente, São Paulo, Brasil, 19060-900
- Unesp - Faculdade de Ciências e Tecnologia (FCT)
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- 18 to 28 years old
- healthy
- no musculoskeletal complaints
Exclusion Criteria:
- failure to follow protocol
- complaints of injury or pain during the assessments
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Sem intervenção: Control
20 minutes of rest |
|
|
Experimental: Cryotherapy
20 minutes of cryotherapy on the dominant ankle with ice bags |
20 minutes of cryotherapy on the dominant ankle with ice bags |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Ankle balance
Prazo: Change from baseline to 20 minutes
|
The Modified Star Excursion Balance Test will measure lower limb reach distance in centimeters |
Change from baseline to 20 minutes
|
|
Ankle balance
Prazo: Change from baseline to 40 minutes
|
The Modified Star Excursion Balance Test will measure lower limb reach distance in centimeters |
Change from baseline to 40 minutes
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Thermic Comfort
Prazo: Change from baseline to 20 minutes
|
a 10cm scale ranging from 0 "very comfortable" and 10 "very uncomfortable" will be used |
Change from baseline to 20 minutes
|
|
Thermic Comfort
Prazo: Change from baseline to 40 minutes
|
a 10cm scale ranging from 0 "very comfortable" and 10 "very uncomfortable" will be used |
Change from baseline to 40 minutes
|
|
Skin Temperature
Prazo: Change from baseline to 20 minutes
|
thermographic camera FLIR E-8 XT (FLIR Systems, Sweden) |
Change from baseline to 20 minutes
|
|
Skin Temperature
Prazo: Change from baseline to 25 minutes
|
thermographic camera FLIR E-8 XT (FLIR Systems, Sweden) |
Change from baseline to 25 minutes
|
|
Skin Temperature
Prazo: Change from baseline to 30 minutes
|
thermographic camera FLIR E-8 XT (FLIR Systems, Sweden) |
Change from baseline to 30 minutes
|
|
Skin Temperature
Prazo: Change from baseline to 35 minutes
|
thermographic camera FLIR E-8 XT (FLIR Systems, Sweden) |
Change from baseline to 35 minutes
|
|
Skin Temperature
Prazo: Change from baseline to 40 minutes
|
thermographic camera FLIR E-8 XT (FLIR Systems, Sweden) |
Change from baseline to 40 minutes
|
|
Balance Perception
Prazo: Change from baseline to 20 minutes
|
a likert scale will be used to answer the question " How good was your balance over the test?" 1=nothing, 2=a little, 3=moderate, 4= a lot, 5=extremely |
Change from baseline to 20 minutes
|
|
Balance Perception
Prazo: Change from baseline to 40 minutes
|
a likert scale will be used to answer the question " How good was your balance over the test?" 1=nothing, 2=a little, 3=moderate, 4= a lot, 5=extremely |
Change from baseline to 40 minutes
|
|
muscle tone
Prazo: Change from baseline to 20 minutes
|
Muscle tone will be measured in hertz by the MyotonPRO wich has a probe that will be placed perpendicular to the skin surface on the muscle belly previously marked with a pen by the evaluator at the tibialis anterior and soleus |
Change from baseline to 20 minutes
|
|
muscle tone
Prazo: Change from baseline to 25 minutes
|
Muscle tone will be measured in hertz by the MyotonPRO wich has a probe that will be placed perpendicular to the skin surface on the muscle belly previously marked with a pen by the evaluator at the tibialis anterior and soleus |
Change from baseline to 25 minutes
|
|
muscle tone
Prazo: Change from baseline to 30 minutes
|
Muscle tone will be measured in hertz by the MyotonPRO wich has a probe that will be placed perpendicular to the skin surface on the muscle belly previously marked with a pen by the evaluator at the tibialis anterior and soleus |
Change from baseline to 30 minutes
|
|
muscle tone
Prazo: Change from baseline to 35 minutes
|
Muscle tone will be measured in hertz by the MyotonPRO wich has a probe that will be placed perpendicular to the skin surface on the muscle belly previously marked with a pen by the evaluator at the tibialis anterior and soleus |
Change from baseline to 35 minutes
|
|
muscle tone
Prazo: Change from baseline to 40 minutes
|
Muscle tone will be measured in hertz by the MyotonPRO wich has a probe that will be placed perpendicular to the skin surface on the muscle belly previously marked with a pen by the evaluator at the tibialis anterior and soleus |
Change from baseline to 40 minutes
|
|
Beliefs
Prazo: baseline
|
The participants will respond yes or no to the questions "Do you believe that cryotherapy is an effect treatment for acute injuries?" and "Do you believe cryotherapy have deleterious effects on muscle function?" |
baseline
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Carlos M Pastre, PhD, São Paulo State University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- EC003
Plano para dados de participantes individuais (IPD)
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