Nctid:
NCT06233175
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000010003", "term"=>"Osteoarthritis"}, {"id"=>"D000020370", "term"=>"Osteoarthritis, Knee"}], "ancestors"=>[{"id"=>"D000001168", "term"=>"Arthritis"}, {"id"=>"D000007592", "term"=>"Joint Diseases"}, {"id"=>"D000009140", "term"=>"Musculoskeletal Diseases"}, {"id"=>"D000012216", "term"=>"Rheumatic Diseases"}], "browseLeaves"=>[{"id"=>"M12926", "name"=>"Osteoarthritis", "asFound"=>"Osteoarthritis", "relevance"=>"HIGH"}, {"id"=>"M22168", "name"=>"Osteoarthritis, Knee", "asFound"=>"Knee Osteoarthritis", "relevance"=>"HIGH"}, {"id"=>"M4476", "name"=>"Arthritis", "relevance"=>"LOW"}, {"id"=>"M10621", "name"=>"Joint Diseases", "relevance"=>"LOW"}, {"id"=>"M12097", "name"=>"Musculoskeletal Diseases", "relevance"=>"LOW"}, {"id"=>"M15045", "name"=>"Rheumatic Diseases", "relevance"=>"LOW"}, {"id"=>"M6323", "name"=>"Collagen Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Musculoskeletal Diseases", "abbrev"=>"BC05"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE", "whoMasked"=>["PARTICIPANT", "OUTCOMES_ASSESSOR"], "maskingDescription"=>"I will assess the patient before and after end of intervention programme"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>34}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-04-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-29", "studyFirstSubmitDate"=>"2024-01-20", "studyFirstSubmitQcDate"=>"2024-01-29", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-03-30", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"static quadriceps strength", "timeFrame"=>"Evaluation will be performed prior to the first treatment session ;as a baseline measure,and at last treatment session (after 4 weeks) as a post -treatment measure", "description"=>"measuring static quadriceps from sitting position at angle 60 and 90"}, {"measure"=>"static hamstring strength", "timeFrame"=>"Evaluation will be performed prior to the first treatment session ;as a baseline measure,and at last treatment session (after 4 weeks) as a post -treatment measure", "description"=>"measuring static hamstring strength from sitting position at angle 60 and 90"}, {"measure"=>"dynamic quadriceps strength", "timeFrame"=>"Evaluation will be performed prior to the first treatment session ;as a baseline measure,and at last treatment session (after 4 weeks) as a post -treatment measure", "description"=>"measuring dynamic quadriceps strength from sitting position by randomised free weight and Brzycki formula"}, {"measure"=>"dynamic hamstring strength", "timeFrame"=>"Evaluation will be performed prior to the first treatment session ;as a baseline measure,and at last treatment session (after 4 weeks) as a post -treatment measure", "description"=>"measuring dynamic hamstring strength from prone position by randomised free weight and Brzycki formula"}, {"measure"=>"Hamstring /Quadriceps ((H/Q) ratio", "timeFrame"=>"Evaluation will be performed prior to the first treatment session ;as a baseline measure,and at last treatment session (after 4 weeks) as a post -treatment measure", "description"=>"dividing static hamstring on static quadriceps strength and dynamic hamstring on dynamic quadriceps strength"}], "secondaryOutcomes"=>[{"measure"=>"change in neck pain", "timeFrame"=>"Evaluation will be performed prior to the first treatment session ;as a baseline measure,and at last treatment session (after 4 weeks) as a post -treatment measure", "description"=>"by Visual Analog Scale (VAS) , (0=no pain ) and (10=worst pain)"}, {"measure"=>"function", "timeFrame"=>"Evaluation will be performed prior to the first treatment session ;as a baseline measure,and at last treatment session (after 4 weeks) as a post -treatment measure", "description"=>"BYWestern Ontario and McMaster Universities Osteoarthritis Index questionnaire ,Lower score indicate patient gets better"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["static knee strength,", "dynamic knee strength", "combined kinetic chain exercises", "osteoarthritis"], "conditions"=>["Knee Osteoarthritis"]}, "descriptionModule"=>{"briefSummary"=>"study will be conducted at faculty of physical therapy cairo university to investigate the effect of combined kinetic chain exercises on static and dynamic hamstring and quadriceps strength in knee osteoarthritis patients", "detailedDescription"=>"the study will be conducted at faculty of physical therapy cairo university to investigate the effect of combined kinetic chain exercises on static and dynamic hamstring and quadriceps strength ,knee pain ,function ,H/Q ratio in knee osteoarthritis patients .using lafayette hand held dynamometer to measuring static strength of hamstring and quadriceps ,and free weight by Brzycki formula for measuring dynamic hamstring and quadriceps strength by determining 1 repetition maximum ,and pain measured by visual analogue scale (VAS) rating from (0 = no pain ) to (10= worst pain ) ,and function by Western Ontario and McMaster Universities Osteoarthritis Index questionnaire lower score indicate patient get better ,number of patients will be 34 divided into 2 groups ,each group will include 17 patient ,with 2 drop out according to sample size calculation ,each group will receive conventional tens for 20 min. and hot back for 15 min. and stretching exercises for hamstring,quadriceps,calf muscles ,while the experimental group will be increased by combined kinetic chain exercises"}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"65 years", "minimumAge"=>"38 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* the patients age from38 to 65\n* recent radiographs confirming grade 2 and 3 (mild to moderate ) osteoarthritis\n* primary and secondary Osteoarthritis\n* both gender\n* unilateral knee osteoarthritis\n* pain in the knee for most days of prior month\n* morning stiffness less than 30 min. in duration\n* patient body mass index (BMI) between 18.5 and 29.9 kg/m2\n\nExclusion Criteria:\n\n* neurological disorders\n* wheelchair bound\n* significant cognitive impairment\n* present systemic inflammatory arthritis\n* history of hip and knee arthroplasty\n\n * history of trauma or surgical arthroscopy of either knee in the last 6 months\n* received knee intra-articular injection within the last 3 months\n* under anticoagulant therapy ,recent or imminent surgery (within 3 months)"}, "identificationModule"=>{"nctId"=>"NCT06233175", "briefTitle"=>"Combined Kinetic Chain Exercises on Knee Osteoarthritis", "organization"=>{"class"=>"OTHER", "fullName"=>"Cairo University"}, "officialTitle"=>"Combined Open And Closed Kinetic Chain Exercises On Static And Dynamic Strength Of Hamstring And Quadriceps In Knee Osteoarthritis Patients", "orgStudyIdInfo"=>{"id"=>"P.T.REC/012/004731"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"conventional group", "description"=>"patients take conventional trans cutaneous electrical stimulation (tens) with a frequency of 100 Hz , a pulse duration of 60 micro seconds for 20 min. ,hot backs for 15 min,stretching exercises for hamstring ,quadriceps ,calf muscles", "interventionNames"=>["Other: conventional"]}, {"type"=>"EXPERIMENTAL", "label"=>"interventional group", "description"=>"patients take conventional tens with a frequency of 100 Hz , a pulse duration of 60 micro seconds for 20 min. ,hot backs for 15 min,stretching exercises for hamstring ,quadriceps ,calf muscles with combined kinetic chain exercises (terminal knee extension,semi squat (wall slide) ,foreword step up and down ,straight leg raise ,seated knee extension )", "interventionNames"=>["Other: combined kinetic chain exercises"]}], "interventions"=>[{"name"=>"combined kinetic chain exercises", "type"=>"OTHER", "otherNames"=>["experimental"], "description"=>"combined kinetic chain exercises in form of wall slide ,terminal knee extension ,forward step up and down ,side step up and down ,straight leg raise ,seated knee extension ,stretching exercises , hot back and trans cutaneous electrical stimulation,", "armGroupLabels"=>["interventional group"]}, {"name"=>"conventional", "type"=>"OTHER", "otherNames"=>["control"], "description"=>"stretching exercises and hot back and trans cutaneous electrical stimulation,with out combined kinetic chain exercises", "armGroupLabels"=>["conventional group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Cairo", "status"=>"RECRUITING", "country"=>"Egypt", "contacts"=>[{"name"=>"hadeer a el sayaad, bachelor's", "role"=>"CONTACT"}], "facility"=>"Faculty of Physical Therapy", "geoPoint"=>{"lat"=>30.06263, "lon"=>31.24967}}], "centralContacts"=>[{"name"=>"hadeer a el sayaad", "role"=>"CONTACT", "email"=>"hadirelsayaad95@gmail.com", "phone"=>"01064125662"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Cairo University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"principal investigator", "investigatorFullName"=>"hadeer Ali El sayaad", "investigatorAffiliation"=>"Cairo University"}}}}
