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临床试验/NCT04303221
NCT04303221Unknown不适用

Effects of the Anchor System in the Postural Stability of Women Submitted to the Treatment of Breast Cancer

Elaine Caldeira de Oliveira Guirro2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
2
主要终点
Functional balance

研究概览

简要总结

Evaluate the effect of a balance rehabilitation program associated or not with the use of the anchor system, on the postural control of women undergoing breast cancer treatment.

详细描述

The aim of this study is to compare the effects of an exercise program associated or not with a non-rigid instrument, called the anchor system, on the postural control of women undergoing breast cancer treatment. For this purpose, 80 women submitted to breast cancer treatment will be invited to participate, divided into four homogeneous groups, determined by the sample calculation: women submitted to breast cancer treatment in the age group of 35 to 59 years (young adult) with lymphedema (GAJL), women in the same age group without lymphedema (GAJ), women in the age group 60 to 80 years (elderly) with lymphedema (GIL), and women in the same age group without lymphedema (GI). Cognitive status will be assessed by the Mini Mental State Examination. To assess the subsystems responsible for maintaining balance, the Balance Evaluation Systems Test (BESTest) will be used, presented in order to guide clinical intervention, in addition to the Falls Efficacy Scale -International (FES-I). The distribution of plantar pressure and balance will be assessed using baropodometry. For data analysis, a normality test and data distribution will be performed, in addition to a statistical test consistent with the appropriate intra and intergroup comparisons, with a significance level of 5%.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
35 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women undergoing treatment for breast cancer, in the 35 to 59 age group with lymphedema, women in the same age group without lymphedema, women in the 60 to 80 age group with lymphedema, and women in the same age group without lymphedema.

排除标准

  • Women diagnosed with rheumatic-orthopedic diseases; with complaints of balance; with injury to the peripheral nervous system of upper or lower limbs.

结局指标

主要结局

Functional balance

时间窗: 5 minutes

Balance evaluation systems test - BESTest

Accidental falls

时间窗: 5 minutes

Falls efficacy scale international - FES-I

Plantar pressure distribution

时间窗: 10 minuntes

Baropodometry system

次要结局

未报告次要终点

研究者

发起方
Elaine Caldeira de Oliveira Guirro
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Elaine Caldeira de Oliveira Guirro

Clinical professor

University of Sao Paulo

研究点 (2)

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