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Clinical Trials/NCT04303221
NCT04303221UnknownNot Applicable

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

Elaine Caldeira de Oliveira Guirro2 sites in 1 country80 target enrollmentStarted: March 1, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
80
Locations
2
Primary Endpoint
Functional balance

Study Overview

Brief Summary

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.

Detailed 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%.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
35 Years to 80 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

Functional balance

Time Frame: 5 minutes

Balance evaluation systems test - BESTest

Accidental falls

Time Frame: 5 minutes

Falls efficacy scale international - FES-I

Plantar pressure distribution

Time Frame: 10 minuntes

Baropodometry system

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Elaine Caldeira de Oliveira Guirro
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Elaine Caldeira de Oliveira Guirro

Clinical professor

University of Sao Paulo

Study Sites (2)

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