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冷冻疗法对踝关节功能的影响

2026年11月10日 更新者：Flávia Carvalho、São Paulo State University

冷冻疗法对踝关节功能的影响：随机临床试验

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

研究概览

地位

完全的

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (实际的)

80

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 巴西
    • São Paulo
      • Presidente Prudente、São Paulo、巴西、19060-900
        • Unesp - Faculdade de Ciências e Tecnologia (FCT)

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 28年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：交叉作业
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
无干预：Control

20 minutes of rest
实验性的：Cryotherapy

20 minutes of cryotherapy on the dominant ankle with ice bags
其他：Cryotherapy

20 minutes of cryotherapy on the dominant ankle with ice bags

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Ankle balance
大体时间：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
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Thermic Comfort
大体时间：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
大体时间：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
大体时间：Change from baseline to 20 minutes

thermographic camera FLIR E-8 XT (FLIR Systems, Sweden)
Change from baseline to 20 minutes
Skin Temperature
大体时间：Change from baseline to 25 minutes

thermographic camera FLIR E-8 XT (FLIR Systems, Sweden)
Change from baseline to 25 minutes
Skin Temperature
大体时间：Change from baseline to 30 minutes

thermographic camera FLIR E-8 XT (FLIR Systems, Sweden)
Change from baseline to 30 minutes
Skin Temperature
大体时间：Change from baseline to 35 minutes

thermographic camera FLIR E-8 XT (FLIR Systems, Sweden)
Change from baseline to 35 minutes
Skin Temperature
大体时间：Change from baseline to 40 minutes

thermographic camera FLIR E-8 XT (FLIR Systems, Sweden)
Change from baseline to 40 minutes
Balance Perception
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

São Paulo State University

调查人员

  • 研究主任：Carlos M Pastre, PhD、São Paulo State University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年5月30日

初级完成 (实际的)

2023年7月1日

研究完成 (实际的)

2023年7月1日

研究注册日期

首次提交

2022年4月8日

首先提交符合 QC 标准的

2022年4月8日

首次发布 (实际的)

2022年4月15日

研究记录更新

最后更新发布 (实际的)

2026年11月12日

上次提交的符合 QC 标准的更新

2026年11月10日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • EC003

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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