Effects of the Anchor System in the Postural Stability
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable breast-cancer
Started Mar 2020
Typical duration for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2020
CompletedFirst Submitted
Initial submission to the registry
March 3, 2020
CompletedFirst Posted
Study publicly available on registry
March 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2024
CompletedMarch 11, 2020
March 1, 2020
2 years
March 3, 2020
March 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Functional balance
Balance evaluation systems test - BESTest
5 minutes
Accidental falls
Falls efficacy scale international - FES-I
5 minutes
Plantar pressure distribution
Baropodometry system
10 minuntes
Study Arms (4)
GAJL - Young adult with lymphedema
EXPERIMENTALWomen age 35 to 59 years (young adult) with lymphedema - exercise group
GAJ - Young adult without lymphedema
EXPERIMENTALWomen age 35 to 59 years (young adult) without lymphedema - exercise group
GIL - Elderly with lymphedema
EXPERIMENTALWomen aged 60 to 80 years (elderly) with lymphedema - exercise group
GI - Elderly without lymphedema
EXPERIMENTALWomen aged 60 to 80 years (elderly) without lymphedema - exercise group
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Women diagnosed with rheumatic-orthopedic diseases; with complaints of balance; with injury to the peripheral nervous system of upper or lower limbs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical School of Ribeirão Preto
Ribeirão Preto, São Paulo, 14049-900, Brazil
Related Publications (1)
Rangon FB, Marinho IL, Cuviena CF, de Moraes R, de Jesus Guirro RR, de Oliveira Guirro EC. Effects of the Anchor System on Postural Balance of Women Undergoing Breast Cancer Treatment: A Clinical, Randomized, Controlled, and Crossover Trial. Arch Phys Med Rehabil. 2024 Feb;105(2):258-267. doi: 10.1016/j.apmr.2023.07.005. Epub 2023 Jul 25.
PMID: 37499853DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elaine Guirro, PhD
University of Sao Paulo - Ribeirao Preto - Brazil
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical professor
Study Record Dates
First Submitted
March 3, 2020
First Posted
March 11, 2020
Study Start
March 1, 2020
Primary Completion
March 1, 2022
Study Completion
March 1, 2024
Last Updated
March 11, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share