Effects of the Anchor System in the Postural Stability

Elaine Caldeira de Oliveira Guirro

Status: Unknown

Conditions: Breast Cancer; Balance; Distorted

Treatments: Other: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT04303221

3474028/2019

Details and patient eligibility

About

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.

Full description

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%.

Enrollment: 80 estimated patients

Sex: Female

Ages: 35 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 4 patient groups

GAJL - Young adult with lymphedema

Experimental group

Description:

Women age 35 to 59 years (young adult) with lymphedema - exercise group

Treatment:

Other: Exercise

GAJ - Young adult without lymphedema

Experimental group

Description:

Women age 35 to 59 years (young adult) without lymphedema - exercise group

Treatment:

Other: Exercise

GIL - Elderly with lymphedema

Experimental group

Description:

Women aged 60 to 80 years (elderly) with lymphedema - exercise group

Treatment:

Other: Exercise

GI - Elderly without lymphedema

Experimental group

Description:

Women aged 60 to 80 years (elderly) without lymphedema - exercise group

Treatment:

Other: Exercise