NCT01519024

Brief Summary

Principles of motor control suggest that breast hypertrophy can lead to sensoriomotor alterations and impairment in body balance due to postural misalignment. The investigators conducted this study to evaluate the postural control with different sensorial information condition in women with breast hypertrophy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 26, 2012

Completed
Last Updated

January 26, 2012

Status Verified

January 1, 2012

Enrollment Period

10 months

First QC Date

January 23, 2012

Last Update Submit

January 25, 2012

Conditions

HypertrophySensation Disorders

Keywords

hypertrophybreastpostural balance

Study Arms (2)

Women with breast hypertrophy

Fourteen women with breast hypertrophy

Women without breast hypertrophy.

Fourteen women without breast hypertrophy for de control group (CG).

Eligibility Criteria

Age24 Years - 73 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The fourteen women for breast hypertropy group were recruited from the Department of Plastic Surgery and Department of Gynecology of Clinical Hospital, Faculty of Medicine, University of São Paulo, and the fourteen women of control group (without breast hypertrophy)was compound by women dwelling community.

You may qualify if:

  • For the breast hypertrophy group, the women had to be in attendance in the Department of Plastic Surgery and Department of Gynecology of Clinical Hospital.

You may not qualify if:

  • For both groups:
  • rheumatic, neurological, respiratory and vestibular conditions due to possible balance alterations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physical Therapy, Speech and Occupational Therapy Department, School of Medicine: University of São Paulo

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

HypertrophySensation Disorders

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsNeurologic ManifestationsNervous System DiseasesSigns and Symptoms

Study Officials

  • Clarice Tanaka, PhD

    Full Professor - Department of Physical Therapy, Communication Science & Disorders, Occupational Therapy, Faculty of Medicine - USP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2012

First Posted

January 26, 2012

Study Start

April 1, 2010

Primary Completion

February 1, 2011

Study Completion

September 1, 2011

Last Updated

January 26, 2012

Record last verified: 2012-01

Locations

BR(1)