Nctid:
NCT06222281
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"CROSS_SECTIONAL", "observationalModel"=>"OTHER"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>35}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-07-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-06", "completionDateStruct"=>{"date"=>"2024-08-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-06-12", "studyFirstSubmitDate"=>"2024-01-04", "studyFirstSubmitQcDate"=>"2024-01-15", "lastUpdatePostDateStruct"=>{"date"=>"2024-06-13", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-24", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-08-15", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"shear wave elastography (SWE)", "timeFrame"=>"Through study completion, an average of 8 weeks", "description"=>"SWE provides an indirect measure of a tissue's mechanical properties by quantifying the speed at which sound waves propagate through soft tissue. Shear wave elastography will be carried out once for both shoulders before the isokinetic tests"}, {"measure"=>"shoulder abduction strength", "timeFrame"=>"Through study completion, an average of 8 weeks", "description"=>"abduction strength of both shoulders will be measured by the isokinetic test method. It will be carried out once for both shoulders for each patient. To measure the muscle strength, the average peak torque (nm) done with four repetitions at a velocity of 60 /sec was determined. It will be carried out once for both shoulders for each patient. Results will be presented in newton metre (nm) unit"}, {"measure"=>"shoulder forward flexion strength", "timeFrame"=>"Through study completion, an average of 8 weeks", "description"=>"forward flexion, strength of both shoulders will be measured by the isokinetic test method. It will be carried out once for both shoulders for each patient. To measure the muscle strength, the average peak torque (nm) done with four repetitions at a velocity of 60 /sec was determined. It will be carried out once for both shoulders for each patient. Results will be presented in newton metre (nm) unit."}, {"measure"=>"shoulder internal rotation strength", "timeFrame"=>"Through study completion, an average of 8 weeks", "description"=>"internal rotation strength of both shoulders will be measured by the isokinetic test method. It will be carried out once for both shoulders for each patient. To measure the muscle strength, the average peak torque (nm) done with four repetitions at a velocity of 60 /sec was determined. It will be carried out once for both shoulders for each patient. Results will be presented in newton metre (nm) unit."}, {"measure"=>"shoulder external rotation strength", "timeFrame"=>"Through study completion, an average of 8 weeks", "description"=>"External rotation strength of both shoulders will be measured by the isokinetic test method. It will be carried out once for both shoulders for each patient. To measure the muscle strength, the average peak torque (nm) done with four repetitions at a velocity of 60 /sec was determined. It will be carried out once for both shoulders for each patient. Results will be presented in newton metre (nm) unit."}, {"measure"=>"Constant-Murley shoulder outcome score", "timeFrame"=>"It will be carried out once for each patient, through study completion, an average of 8 weeks", "description"=>"Patients will fill the constant score questionnaire to evaluate the functional status of operated shoulder. The Constant-Murley score will be used to determine the functionality after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points).The higher the score, the higher the quality of the function"}, {"measure"=>"quick DASH", "timeFrame"=>"It will be carried out once for each patient, through study completion, an average of 8 weeks", "description"=>"Patients will fill the quick disabilities of the arm, shoulder, and hand outcome measure questionnaire (the quick-DASH) to evaluate the functional status of operated shoulder.his questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale.t is a questionnaire that measures an individual's ability to complete tasks, absorb forces, and severity of symptoms.The QuickDASH tool uses a 5-point Likert scale from which the patient can select an appropriate number corresponding to his/her severity/function level."}, {"measure"=>"shoulder abduction endurance", "timeFrame"=>"Through study completion, an average of 8 weeks", "description"=>"to measure the shoulder abduction endurance, total work (nm) done with 15 repetitions at a velocity of 180/sec will be measured by an isokinetic dynomemeter, results will be presented in newton metre (nm) unit"}, {"measure"=>"shoulder forward flexion endurance", "timeFrame"=>"Through study completion, an average of 8 weeks", "description"=>"to measure the shoulder abduction endurance, total work (nm) done with 15 repetitions at a velocity of 180/sec will be measured by an isokinetic dynomemeter, results will be presented in newton metre (nm) unit"}, {"measure"=>"shoulder internal rotation endurance", "timeFrame"=>"Through study completion, an average of 8 weeks", "description"=>"to measure the shoulder abduction endurance, total work (nm) done with 15 repetitions at a velocity of 180/sec will be measured by an isokinetic dynomemeter, results will be presented in newton metre (nm) unit"}, {"measure"=>"shoulder external rotation endurance", "timeFrame"=>"Through study completion, an average of 8 weeks", "description"=>"to measure the shoulder abduction endurance, total work (nm) done with 15 repetitions at a velocity of 180/sec will be measured by an isokinetic dynomemeter, results will be presented in newton metre (nm) unit"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["elastography", "Deltoid", "shoulder strength", "reverse shoulder arthroplasty"], "conditions"=>["Sonoelastography", "Isokinetic Test"]}, "descriptionModule"=>{"briefSummary"=>"The goal of this observational study is to test the strength of the shoulder joint and elasticity of the deltoid muscle of the patients who had a reverse shoulder arthroplasty. The main questions are: • Whether there is a difference between the operated and healthy shoulders in terms of strength and deltoid elasticity of the patients. • Is there any correlation between the functional status, elasticity and strength of the operated shoulder? Participants will be asked to attend the isokinetic shoulder strength tests and shear wawe ultrasound elastography measurements. They will be also asked to fill the quick DASH and Constant score forms.", "detailedDescription"=>"The ultrasound elastography is a measurement method that has become increasingly common recently and can measure some mechanical properties of tissue. Measurements can be made using two different techniques: strain and shear wave elastography (SWEUS). SWEUS provides objective and reproducible data collection about the elasticity of the tissue and is less affected by the user than the strain technique. The mechanical properties of the deltoid muscle are among the main factors affecting surgical results in patients undergoing reverse shoulder replacement surgery. Glenohumeral joint function is affected by the post-operative tension of the deltoid. Excessive tension in the deltoid muscle may cause restriction of movement and pain, as well as conditions such as instability and insufficient force production. Lack of elasticity of deltoid muscle may also lead to functional deficit of shoulder. Previous studies have found a linear correlation between muscle activity and muscle elasticity values measured by MR elastography (MRE). However, MRE is an expensive method that requires large equipment and space, and it is a more difficult method for patients, which may include various difficulties in patient positioning. Ultrasound elastography is a method that is highly investigated for clinical use because it is cheaper and easier to apply than MRE. Isokinetic dynamometer is one of the most objective methods used to measure muscle activity and strength.Thus, it is imperative to reveal the mechanical properties of deltoid muscle, which carries the most of the mechanical load in the shoulder region after the operation, as well as the relationship between them.\n\nThe medical history of patients who had undergone reverse prosthesis surgery in the Department of Orthopedics and Traumatology, and their postoperative files will be screened. Patients who meet the inclusion and exclusion criteria will be invited to the study.\n\nTheir demographic information will be recorded. The visual pain scale (VAS) and will be questioned to evaluate the pain status. Functional status of the patients, and the patients will be asked to complete the Constant score and the quick arm, shoulder and hand problems questionnaire (Q-DASH) under supervision. They will be asked to answer. Shear wave elastographic measurement and isokinetic tests of both shoulders will be carried out in the sports medicine department. Measurement outcomes of both shoulders will be compared."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Patients who were operated in the university hospital, department of orthopedics and traumatology", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Having undergone reverse shoulder arthroplasty surgery due to arthropathy because of unilateral rotator cuff tear\n* Followed for at least 12 months after surgery.\n* The other unoperated shoulder is healthy.\n\nExclusion Criteria:\n\n* Patients with revision reverse shoulder arthroplasty\n* Having inflammatory diseases\n* Not having adequate range of motion to be able to perform isokinetic test"}, "identificationModule"=>{"nctId"=>"NCT06222281", "briefTitle"=>"Evaluation of Shoulder Strength and Deltoid Stiffness After Reverse Shoulder Arthroplasty (RSA)", "organization"=>{"class"=>"OTHER", "fullName"=>"Istanbul University"}, "officialTitle"=>"Evaluation of Shoulder Strength and Deltoid Stiffness After RSA", "orgStudyIdInfo"=>{"id"=>"Elastography RSA"}}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"34093", "city"=>"Istanbul", "country"=>"Turkey", "facility"=>"Şensu Dinçer", "geoPoint"=>{"lat"=>41.01384, "lon"=>28.94966}}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Şensu Dinçer", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR_INVESTIGATOR", "investigatorTitle"=>"medical doctor", "investigatorFullName"=>"Şensu Dinçer", "investigatorAffiliation"=>"Istanbul University"}}}}
