HypertrophyNCT01519024
Postural Control in Breast Hypertrophy
An observational study of Hypertrophy and Sensation Disorders, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 73 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertrophy, Sensation Disorders
- How many people
- 28 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2010to Sep 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 73 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- For both groups:
- rheumatic, neurological, respiratory and vestibular conditions due to possible balance alterations
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Physical Therapy, Speech and Occupational Therapy Department, School of Medicine: University of São Paulo
São Paulo, São Paulo
About this study
Official title: Poorer Postural Control in Women With Breast Hypertrophy.
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.
Read the detailed description
Up to the moment, changes caused by breast hypertrophy are described based on the alteration of body mass distribution leading to an impact of psychological and physical aspects. However, the investigators hypothesize that due to alterations in postural alignment, sensoriomotor inputs are also impaired and postural or motor control are ultimately compromised.
- Conditions
- Hypertrophy, Sensation Disorders
- Keywords
- hypertrophy, breast, postural balance
- Medical subject headings
- Hypertrophy, Sensation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women with breast hypertrophy | Fourteen women with breast hypertrophy | |
| Women without breast hypertrophy. | Fourteen women without breast hypertrophy for de control group (CG). |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2012 (estimated)
- Study startApr 2010
- Primary completionFeb 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clarice Tanaka, PhD, Principal investigator, Full Professor - Department of Physical Therapy, Communication Science & Disorders, Occupational Therapy, Faculty of Medicine - USP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01519024
- Sponsor's protocol ID
- FRACINI_1
- Status last verified
- Jan 2012
- First submitted
- 23 Jan 2012
- Last updated
- 26 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Poorer Postural Control in Women With Breast Hypertrophy.
- ClinicalTrials.gov ID
- NCT01519024
- Acronym / sponsor ID
- FRACINI_1
- Conditions
- Hypertrophy, Sensation Disorders
- Keywords
- hypertrophy, breast, postural balance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 26 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Up to the moment, changes caused by breast hypertrophy are described based on the alteration of body mass distribution leading to an impact of psychological and physical aspects. However, the investigators hypothesize that due to alterations in postural alignment, sensoriomotor inputs are also impaired and postural or motor control are ultimately compromised.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with breast hypertrophy | – | –Fourteen women with breast hypertrophy |
| Women without breast hypertrophy. | – | –Fourteen women without breast hypertrophy for de control group (CG). |
Who may qualify
- Ages
- 24 to 73 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- For both groups:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clarice Tanaka, PhD principal investigator
Full Professor - Department of Physical Therapy, Communication Science & Disorders, Occupational Therapy, Faculty of Medicine - USP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertrophy and Sensation Disorders, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2012.