{
  "FullStudy":{
    "Rank":217620,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01519024",
          "OrgStudyIdInfo":{
            "OrgStudyId":"FRACINI_1"
          },
          "Organization":{
            "OrgFullName":"University of Sao Paulo General Hospital",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Postural Control in Breast Hypertrophy",
          "OfficialTitle":"Poorer Postural Control in Women With Breast Hypertrophy."
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"April 2010"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"February 2011",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"September 2011",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 23, 2012",
          "StudyFirstSubmitQCDate":"January 25, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 26, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 25, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 26, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"University of Sao Paulo General Hospital",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"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.",
          "DetailedDescription":"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."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Hypertrophy",
              "Sensation Disorders"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "hypertrophy",
              "breast",
              "postural balance"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Case Control"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Cross-Sectional"
              ]
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"28",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Women with breast hypertrophy",
                "ArmGroupDescription":"Fourteen women with breast hypertrophy"
              },{
                "ArmGroupLabel":"Women without breast hypertrophy.",
                "ArmGroupDescription":"Fourteen women without breast hypertrophy for de control group (CG)."
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nFor the breast hypertrophy group, the women had to be in attendance in the Department of Plastic Surgery and Department of Gynecology of Clinical Hospital.\n\nExclusion Criteria:\n\nFor both groups:\n\nrheumatic, neurological, respiratory and vestibular conditions due to possible balance alterations",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"Female",
          "MinimumAge":"24 Years",
          "MaximumAge":"73 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          },
          "StudyPopulation":"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.",
          "SamplingMethod":"Non-Probability Sample"
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Clarice Tanaka, PhD",
                "OverallOfficialAffiliation":"Full Professor - Department of Physical Therapy, Communication Science & Disorders, Occupational Therapy, Faculty of Medicine - USP",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Physical Therapy, Speech and Occupational Therapy Department, School of Medicine: University of São Paulo",
                "LocationCity":"São Paulo",
                "LocationCountry":"Brazil"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000012678",
                "ConditionMeshTerm":"Sensation Disorders"
              },{
                "ConditionMeshId":"D000006984",
                "ConditionMeshTerm":"Hypertrophy"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000020763",
                "ConditionAncestorTerm":"Pathological Conditions, Anatomical"
              },{
                "ConditionAncestorId":"D000009461",
                "ConditionAncestorTerm":"Neurologic Manifestations"
              },{
                "ConditionAncestorId":"D000009422",
                "ConditionAncestorTerm":"Nervous System Diseases"
              },{
                "ConditionAncestorId":"D000012816",
                "ConditionAncestorTerm":"Signs and Symptoms"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M8618",
                "ConditionBrowseLeafName":"Hypertrophy",
                "ConditionBrowseLeafAsFound":"Hypertrophy",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M14073",
                "ConditionBrowseLeafName":"Sensation Disorders",
                "ConditionBrowseLeafAsFound":"Sensation Disorders",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M21103",
                "ConditionBrowseLeafName":"Pathological Conditions, Anatomical",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M10987",
                "ConditionBrowseLeafName":"Neurologic Manifestations",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC10",
                "ConditionBrowseBranchName":"Nervous System Diseases"
              }
            ]
          }
        }
      }
    }
  }
}

