{ "FullStudy":{ "Rank":217684, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01518179", "OrgStudyIdInfo":{ "OrgStudyId":"K-11-0131-CTIL" }, "Organization":{ "OrgFullName":"Clalit Health Services", "OrgClass":"OTHER" }, "BriefTitle":"Compression Gloves for Distal Radius Fracture", "OfficialTitle":"The Effect of Wearing Made-to-Measure Compression Gloves on Rehabilitation Following DRF." }, "StatusModule":{ "StatusVerifiedDate":"January 2019", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"April 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"December 31, 2018", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"December 31, 2018", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 21, 2012", "StudyFirstSubmitQCDate":"January 21, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 29, 2019", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 31, 2019", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Uzi Milman", "ResponsiblePartyInvestigatorTitle":"Director, clinical research unit, Clalit Health Services, Haifa", "ResponsiblePartyInvestigatorAffiliation":"Clalit Health Services" }, "LeadSponsor":{ "LeadSponsorName":"Clalit Health Services", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"University of Haifa", "CollaboratorClass":"OTHER" } ] } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"Distal Radius Fractures are among the most common orthopedic injuries. Rehabilitation may be characterized by pain, stiffness, swelling, and decreased range of motion (hand and fingers), and grip strength.\n\nCompression gloves are used to enhance rehabilitation after various clinical conditions and injuries. However, there are no reports on the effect of compression gloves following Distal Radius Fracture (DRF).\n\nThis study aims to assess the incremental effect of wearing Made-to-Measure Compression Gloves on rehabilitation following DRF.\n\nWorking Hypothesis: The addition of Made-to-Measure Compression Gloves to routine follow up and treatment will enhance rehabilitation, when compared with routine follow up and treatment, in patients following Distal Radius Fracture.\n\nICD 10, Version 2010, conditions to be included in the study (defined jointly as Distal Radius Fractures):\n\nS52.5 Fracture of lower end of radius (Colles' fracture, Smith's fracture) S52.6 Fracture of lower end of both ulna and radius S52.7 Multiple fractures of forearm Excl.: fractures of both ulna and radius: lower end (S52.6), shafts (S52.4).\n\nS52.8 Fracture of other parts of forearm (Lower end of ulna, Head of ulna)", "DetailedDescription":"Individuals referred for rehabilitation following DRF will be invited to participate in the study. After obtaining an informed consent individuals will be randomized to receive routine follow up and treatment with or without compression glove. Individuals randomized to made to measure compression gloves will receive them within a week of enrolment. All participating individuals will be assessed by an occupational therapist at enrolment and 2, 4, and 8 week after enrolment. Additional telephone interview, to assess long term effect, will be conducted at 3, 6 and 12 months." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Distal Radius Fractures", "Fracture of Lower End of Radius", "Colles' Fracture", "Smith's Fracture" ] }, "KeywordList":{ "Keyword":[ "Colles' Fracture", "Compression Bandages", "Occupational therapy", "Rehabilitation", "Smith's fracture" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"35", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Made-to-Measure Compression Gloves", "ArmGroupType":"Experimental", "ArmGroupDescription":"Made-to-Measure Compression Gloves in addition to routine follow up and treatment.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Device: Made-to-Measure Compression Gloves" ] } },{ "ArmGroupLabel":"Control", "ArmGroupType":"Other", "ArmGroupDescription":"Routine follow up and treatment", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Other: Routine follow up and treatment" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Device", "InterventionName":"Made-to-Measure Compression Gloves", "InterventionDescription":"Made-to-Measure Compression Gloves in addition to routine follow up and treatment.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Made-to-Measure Compression Gloves" ] } },{ "InterventionType":"Other", "InterventionName":"Routine follow up and treatment", "InterventionDescription":"Control", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Control" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Functional Activities of Daily Living (ADL) by self reported assessment using the Patient Rating Wrist Evaluation (PRWE).", "PrimaryOutcomeDescription":"Functional Activities of Daily Living (ADL) by self reported assessment using the Patient Rating Wrist Evaluation (PRWE).", "PrimaryOutcomeTimeFrame":"1 year" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Swelling of the hand and fingers (using CM ribbon)", "SecondaryOutcomeDescription":"Swelling of the hand and fingers (using CM ribbon)", "SecondaryOutcomeTimeFrame":"10 week" },{ "SecondaryOutcomeMeasure":"Range of motion of the fingers and wrist (using Goniomater)", "SecondaryOutcomeDescription":"Range of motion of the fingers and wrist (using Goniomater)", "SecondaryOutcomeTimeFrame":"10 weeks" },{ "SecondaryOutcomeMeasure":"Strength of the hand (using the Gamar Dynamometer in KG).", "SecondaryOutcomeDescription":"Strength of the hand (using the Gamar Dynamometer in KG).", "SecondaryOutcomeTimeFrame":"10 weeks" },{ "SecondaryOutcomeMeasure":"Pain (using VAS as part of PRWE)", "SecondaryOutcomeDescription":"Pain (using VAS as part of PRWE)", "SecondaryOutcomeTimeFrame":"10 weeks" },{ "SecondaryOutcomeMeasure":"Overall satisfaction of using the compression gloves (using self reported questionnaire).", "SecondaryOutcomeDescription":"Overall satisfaction of using the compression gloves (using self reported questionnaire).", "SecondaryOutcomeTimeFrame":"10 weeks" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\n4-6 weeks following either surgical or conservative treatment for distal Radius fractures, with or without the involvement of the Ulna.\n\nPatients who demonstrate at enrolment at least two of the following:\n\nPain,\nlimited range of motion of the fingers and the wrist,\nlimited strength (weakness of the hand/fingers),\nswelling /edema,\nLimited hand functions during performance of Activities of Daily Living (ADL).\n\nExclusion Criteria:\n\nNeuropathy\nPeripheral vascular disease\nEnd stage renal disease\nPrevious impairment of fingers/wrist range of motion.\nPrevious Lymphedema of the injured hand\nReceiving any additional treatments which is not included in the routine follow up and treatment (i.e. acupuncture, steroids).\nPregnancy", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"85 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Benny Brnfeld, MD", "OverallOfficialAffiliation":"Clalit Health Services", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"Uzi Milman, MD", "OverallOfficialAffiliation":"Clalit Health Services", "OverallOfficialRole":"Study Director" },{ "OverallOfficialName":"Naomi Schreuer, Ph.D., OTR", "OverallOfficialAffiliation":"Faculty of Social Welfare & Health Sciences, University of Haifa, Haifa, ISRAEL", "OverallOfficialRole":"Study Chair" },{ "OverallOfficialName":"Inbar Miler, OCT", "OverallOfficialAffiliation":"Clalit Health Services", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Clalit Health Services, Haifa and Western Galilee District", "LocationCity":"Haifa", "LocationCountry":"Israel" },{ "LocationFacility":"Clalit Health Services", "LocationCity":"Haifa", "LocationCountry":"Israel" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"29994792", "ReferenceType":"result", "ReferenceCitation":"Miller-Shahabar I, Schreuer N, Katsevman H, Bernfeld B, Cons A, Raisman Y, Milman U. Efficacy of Compression Gloves in the Rehabilitation of Distal Radius Fractures: Randomized Controlled Study. Am J Phys Med Rehabil. 2018 Dec;97(12):904-910. doi: 10.1097/PHM.0000000000000998." } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000003100", "ConditionMeshTerm":"Colles' Fracture" },{ "ConditionMeshId":"D000050723", "ConditionMeshTerm":"Fractures, Bone" },{ "ConditionMeshId":"D000011885", "ConditionMeshTerm":"Radius Fractures" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000014947", "ConditionAncestorTerm":"Wounds and Injuries" },{ "ConditionAncestorId":"D000005543", "ConditionAncestorTerm":"Forearm Injuries" },{ "ConditionAncestorId":"D000001134", "ConditionAncestorTerm":"Arm Injuries" },{ "ConditionAncestorId":"D000072039", "ConditionAncestorTerm":"Fracture Dislocation" },{ "ConditionAncestorId":"D000004204", "ConditionAncestorTerm":"Joint Dislocations" },{ "ConditionAncestorId":"D000007592", "ConditionAncestorTerm":"Joint Diseases" },{ "ConditionAncestorId":"D000009140", "ConditionAncestorTerm":"Musculoskeletal Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M24957", "ConditionBrowseLeafName":"Fractures, Bone", "ConditionBrowseLeafAsFound":"Fracture", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M13314", "ConditionBrowseLeafName":"Radius Fractures", "ConditionBrowseLeafAsFound":"Radius Fractures", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M4911", "ConditionBrowseLeafName":"Colles' Fracture", "ConditionBrowseLeafAsFound":"Colles' Fracture", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M16268", "ConditionBrowseLeafName":"Wounds and Injuries", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M7250", "ConditionBrowseLeafName":"Forearm Injuries", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3025", "ConditionBrowseLeafName":"Arm Injuries", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M5968", "ConditionBrowseLeafName":"Joint Dislocations", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M909", "ConditionBrowseLeafName":"Fracture Dislocation", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M9204", "ConditionBrowseLeafName":"Joint Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10680", "ConditionBrowseLeafName":"Musculoskeletal Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC26", "ConditionBrowseBranchName":"Wounds and Injuries" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC05", "ConditionBrowseBranchName":"Muscle, Bone, and Cartilage Diseases" } ] } } } } } }