Nctid:
NCT06226688
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-27"}, "conditionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M5220", "name"=>"Breast Neoplasms", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE", "whoMasked"=>["PARTICIPANT", "INVESTIGATOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"RCT 2 groups One of them control group And the other is study group"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>54}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2023-10-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-07", "completionDateStruct"=>{"date"=>"2024-05-09", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-07-31", "studyFirstSubmitDate"=>"2024-01-14", "studyFirstSubmitQcDate"=>"2024-01-18", "lastUpdatePostDateStruct"=>{"date"=>"2024-08-02", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-05-05", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Measure before and after shoulder muscles strength by hand held dynamometer", "timeFrame"=>"6 wweks", "description"=>"Measuring"}]}, "oversightModule"=>{"isUsExport"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Breast Cancer Female"]}, "descriptionModule"=>{"briefSummary"=>"PURPOSE:The purpose of the study is to evaluate the effect of biofeedback on shoulder muscles strength post mastectomy.\n\nBACKGROUND:\n\n* The most common complications following mastectomy are pain, ipsilateral lymphedema of the upper limb (UL), reduced range of motion (ROM) of the shoulder, flexion and abduction is limited to 90°, and external rotation is limited to 40°, and there are postural changes\n* One of the most common complications after breast cancer surgery is a functional limitation of the upper body. Up to 67% of breast cancer patients experience arm or shoulder impairment, including pain, numbness, loss of strength, and reduced ROM, after surgery\n* Shoulder problems in breast cancer patients affect their daily activities, such as pulling a sweater overhead, fastening a bra, zipping up a back zipper, reaching overhead, and carrying heavy bags.\n* Biofeedback is a mind-body technique in which individuals learn how to modify their physiology for the purpose of improving physical, mental, emotional and spiritual health. Much like physical therapy, biofeedback training requires active participation on the part of patients and often regular practice between training sessions. Clinical biofeedback may be used to manage disease symptoms as well as to improve overall health and wellness through stress management training. Research has shown that biofeedback interventions are efficacious in treating a variety of medical conditions, and many Americans are turning to biofeedback and other less traditional therapies for their (Dana et al., 2010).\n\nHYPOTHESES: null hypothesis\n\nRESEARCH QUESTION: Does biofeedback give effect on shoulder muscles strength post mastectomy?", "detailedDescription"=>"27 patient per group to G power 90% a Inclusion Criteria:\n\nThe subject selection will be according to the following criteria:\n\n* Female patients with age range between 40-60 will participate in the study.\n* All patients with their informed consent.\n* All patients with unilateral mastectomy\n* All patients have shoulder muscle weakness within 2 to 4 months post mastectomy\n* All patients with chemo or radio therapy 1.2.b Exclusion Criteria:\n\nThe potential participants will be excluded if they meet one of the following criteria:\n\n* metastasis\n* Psychological Disorder\n* Lymphedema\n* Neurological or musculoskeletal disorders"}, "eligibilityModule"=>{"sex"=>"FEMALE", "stdAges"=>["ADULT"], "maximumAge"=>"60 years", "minimumAge"=>"40 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* The subject selection will be according to the following criteria:\n* Female patients with age range between 40-60 will participate in the study.\n* All patients with their informed consent.\n* All patients with unilateral mastectomy\n* All patients have shoulder muscle weakness within 2 to 4 months post mastectomy\n* All patients with chemo or radio therapy\n\nExclusion Criteria:\n\n* The potential participants will be excluded if they meet one of the following criteria:\n* metastasis\n* Psychological Disorder\n* Lymphedema\n* Neurological or musculoskeletal disorders"}, "identificationModule"=>{"nctId"=>"NCT06226688", "briefTitle"=>"Biofeedback Training on Shoulder Muscles Strength Post Mastectomy", "organization"=>{"class"=>"OTHER", "fullName"=>"Cairo University"}, "officialTitle"=>"Biofeedback Training on Shoulder Muscles Strength Post Mastectomy", "orgStudyIdInfo"=>{"id"=>"P.T.REC/012/004823"}, "secondaryIdInfos"=>[{"id"=>"202309250044", "type"=>"REGISTRY", "domain"=>"Baheya research center"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Affected arm at the same side of mastectomy", "description"=>"There is 2 arms Arm1:-arm at side of mastectomy without lymphedema trained by biofeedback", "interventionNames"=>["Procedure: Biofeedback device and other group control group", "Procedure: Control group"]}, {"type"=>"EXPERIMENTAL", "label"=>"2 arms one trained by biofeedback and other control without biofeedback", "description"=>"Arm2:-arm at side of mastectomy on other group but not trained with biofeedback Training using shoulder ladder ,shoulder wheel ,shoulder mobilization and IPC", "interventionNames"=>["Procedure: Control group"]}], "interventions"=>[{"name"=>"Biofeedback device and other group control group", "type"=>"PROCEDURE", "otherNames"=>["Expirmental trial by biofeedback device"], "description"=>"Intervention 1 :-Using the biofeedback device with dumble to strength affected arm post mastectomy", "armGroupLabels"=>["Affected arm at the same side of mastectomy"]}, {"name"=>"Control group", "type"=>"PROCEDURE", "otherNames"=>["Intervention 2 :- using traditional PT programme without using biofeedback"], "description"=>"Shoulder mobilization Shoulder ladder ex Shoulder wheel ex Ipc", "armGroupLabels"=>["2 arms one trained by biofeedback and other control without biofeedback", "Affected arm at the same side of mastectomy"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"02", "city"=>"Cairo", "state"=>"Bahyea Foundation For Breast Cancer", "country"=>"Egypt", "facility"=>"Nourhan Souliman", "geoPoint"=>{"lat"=>30.06263, "lon"=>31.24967}}, {"zip"=>"02", "city"=>"Cairo", "country"=>"Egypt", "facility"=>"Nourhan Ahmed mahmoud souliman", "geoPoint"=>{"lat"=>30.06263, "lon"=>31.24967}}], "overallOfficials"=>[{"name"=>"Research ethical commity Physical therapy Cairo university", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Research ethical commity"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Cairo University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Demonstrator", "investigatorFullName"=>"Nourhan Ahmed Mahmoud Souliman", "investigatorAffiliation"=>"Cairo University"}}}}
