{
  "FullStudy":{
    "Rank":218172,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01511796",
          "OrgStudyIdInfo":{
            "OrgStudyId":"BTul Rehab"
          },
          "Organization":{
            "OrgFullName":"Toronto Rehabilitation Institute",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Examining the Effectiveness of Combined Rehabilitation and Botulinum Toxin Injection on Functional Improvement of the Upper Limb After Stroke",
          "OfficialTitle":"Effectiveness of Botulinum Toxin Combined With Upper Limb Rehabilitation on Arm Function"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2012",
          "OverallStatus":"Unknown status",
          "LastKnownStatus":"Enrolling by invitation",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"April 2013",
            "PrimaryCompletionDateType":"Anticipated"
          },
          "CompletionDateStruct":{
            "CompletionDate":"April 2014",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"January 6, 2012",
          "StudyFirstSubmitQCDate":"January 17, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 19, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 17, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 19, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Parvin Eftekhar",
            "ResponsiblePartyInvestigatorTitle":"principal inverstigator",
            "ResponsiblePartyInvestigatorAffiliation":"Toronto Rehabilitation Institute"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Toronto Rehabilitation Institute",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"University of Toronto",
                "CollaboratorClass":"OTHER"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of this study is to examine the effects of a combination of \"Botulinum Toxin (BT) and Upper Limb (UL) rehabilitation\" compared to \"BT only\" on UL motor function in adults with spasticity after stroke using a pre-post design. The research question is whether combination of BT and UL rehabilitation compared to BT only is more effective in improving the UL function, range of motion and pain."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Stroke"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "stroke",
              "upper limb rehabilitation function"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 3"
            ]
          },
          "DesignInfo":{
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"38",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"upper limb rehabilitation for total of 6 months",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"upper limb rehabiliation",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Other: upper limb rehabiliation"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Other",
                "InterventionName":"upper limb rehabiliation",
                "InterventionDescription":"3 months upper rehabilation (twice a week) and then 3 more months upper limb rehabitation ( twice a week)",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "upper limb rehabilitation for total of 6 months"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Modified Ashworth",
                "PrimaryOutcomeTimeFrame":"up tp 2013"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Goal attaiment Scale",
                "SecondaryOutcomeTimeFrame":"up tp 2013"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nover 18 years of age\nat least 4 months post stroke\npresent with UL spasticity (MAS >1 in elbow and/or spasticity of the hand, wrist or shoulder)\npresent with at lease a stage 3 of CMSA\nable to comply with the requirements of the protocol and UL therapy programme.\n\nExclusion Criteria:\n\nsignificant cognitive and speech impairments\nother upper limb impairments such as frozen shoulder\nanother diagnosis which could contribute to upper limb spasticity .",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"75 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Toronto Rehabiliation institute",
                "LocationCity":"Toronto",
                "LocationState":"Ontario",
                "LocationZip":"M5G 2A2",
                "LocationCountry":"Canada"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000020521",
                "ConditionMeshTerm":"Stroke"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000002561",
                "ConditionAncestorTerm":"Cerebrovascular Disorders"
              },{
                "ConditionAncestorId":"D000001927",
                "ConditionAncestorTerm":"Brain Diseases"
              },{
                "ConditionAncestorId":"D000002493",
                "ConditionAncestorTerm":"Central Nervous System Diseases"
              },{
                "ConditionAncestorId":"D000009422",
                "ConditionAncestorTerm":"Nervous System Diseases"
              },{
                "ConditionAncestorId":"D000014652",
                "ConditionAncestorTerm":"Vascular Diseases"
              },{
                "ConditionAncestorId":"D000002318",
                "ConditionAncestorTerm":"Cardiovascular Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M20890",
                "ConditionBrowseLeafName":"Stroke",
                "ConditionBrowseLeafAsFound":"Stroke",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M4393",
                "ConditionBrowseLeafName":"Cerebrovascular Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3786",
                "ConditionBrowseLeafName":"Brain Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M4325",
                "ConditionBrowseLeafName":"Central Nervous System Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M15983",
                "ConditionBrowseLeafName":"Vascular Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC10",
                "ConditionBrowseBranchName":"Nervous System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC14",
                "ConditionBrowseBranchName":"Heart and Blood Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}