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Effects of the Anchor System in the Postural Stability

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04303221
Enrollment
80
Registered
2020-03-11
Start date
2020-03-01
Completion date
2024-03-01
Last updated
2020-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Balance; Distorted, Breast Cancer

Keywords

Breast cancer, Lymphedema, Postural balance, Falls

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%.

Interventions

OTHERExercise

The exercises will be performed three times a week (Mondays, Wednesdays and Fridays), lasting 60 min, 10 minutes of warm-up, 40 min of multisensory exercises, and 10 min of final relaxation, for 12 weeks.

Sponsors

Elaine Caldeira de Oliveira Guirro
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
35 Years to 80 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Functional balance5 minutesBalance evaluation systems test - BESTest
Accidental falls5 minutesFalls efficacy scale international - FES-I
Plantar pressure distribution10 minuntesBaropodometry system

Countries

Brazil

Contacts

Primary ContactElaine C Guirro, PhD
ecguirro@fmrp.usp.br(16)33150215
Backup ContactFlávia B Rangon
flavia.rangon@gmail.com(16)33150215

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026