Nctid:
NCT06233136
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000002547", "term"=>"Cerebral Palsy"}], "ancestors"=>[{"id"=>"D000001925", "term"=>"Brain Damage, Chronic"}, {"id"=>"D000001927", "term"=>"Brain Diseases"}, {"id"=>"D000002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}], "browseLeaves"=>[{"id"=>"M13157", "name"=>"Paralysis", "relevance"=>"LOW"}, {"id"=>"M5796", "name"=>"Cerebral Palsy", "asFound"=>"Cerebral Palsy", "relevance"=>"HIGH"}, {"id"=>"M12085", "name"=>"Muscle Spasticity", "relevance"=>"LOW"}, {"id"=>"M5207", "name"=>"Brain Injuries", "relevance"=>"LOW"}, {"id"=>"M5202", "name"=>"Brain Damage, Chronic", "relevance"=>"LOW"}, {"id"=>"M5204", "name"=>"Brain Diseases", "relevance"=>"LOW"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"T5292", "name"=>"Spastic Diplegia Cerebral Palsy", "asFound"=>"Cerebral Palsy Spastic Diplegia", "relevance"=>"HIGH"}, {"id"=>"T1303", "name"=>"Chronic Graft Versus Host Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Musculoskeletal Diseases", "abbrev"=>"BC05"}, {"name"=>"Wounds and Injuries", "abbrev"=>"BC26"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["PARTICIPANT"], "maskingDescription"=>"Single"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>40}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2023-03-13", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2023-08-15", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-01-30", "studyFirstSubmitDate"=>"2023-07-24", "studyFirstSubmitQcDate"=>"2024-01-30", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2023-07-15", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"The gross motor function scale", "timeFrame"=>"2 months for each participant", "description"=>"Assessment of change of functional ability carried out by using gross motor function measures"}, {"measure"=>"Assessment of trunk control", "timeFrame"=>"2 months for each participant", "description"=>"Assessment of change of trunk control carried out by using trunk control measurement scale"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Leg Pedalling"], "conditions"=>["Cerebral Palsy Spastic Diplegia"]}, "descriptionModule"=>{"briefSummary"=>"Statement of the problem:- Does the lower limb pedalling exercise from inclined position improve functional ability and trunk control in children with diplegic cerebral palsy? Null Hypothesis:- There will be no effect of lower limb pedalling exercise from inclined position on functional ability and trunk control in children with diplegic cerebral palsy", "detailedDescription"=>"Subjects A convenient sample of children diagnosed as spastic diplegic cerebral palsy (CP) from both sexes will be recruited based on a pilot study according to the inclusion and exclusion criteria. They will be selected from the out-patient private clinics in Giza and Tenth of Ramadan City.\n\nStudy design:\n\nRandomized controlled clinical trial. Children will receive intervention type randomly, 15 child received the designed physical therapy program and the pedaling exercise from inclined position and the other 15 child receieved the designed physical therapy program only. Children will be assessed by measuring functional ability with Gross Motor Functional measures and trunk control with trunk control measurement scale"}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD"], "maximumAge"=>"9 years", "minimumAge"=>"6 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n.Age ranges from 6-9 years. .Grade 1, 1+ of the Modified Ashworth Scale.\n\n.Level II, III according to Gross MotorFunctional Classification System (GMFCS).\n\n.Able to pedal independently on a static bicycle.\n\n.Ability to follow command.\n\nExclusion Criteria:\n\n.Significant visual or auditory impairments.\n\n.Structural or fixed deformities of lower extremities.\n\n.Perception disorders.\n\n.Botox injection in the lower extremity in the past 6 months.\n\n.Lower extremity surgery within the past 6 months."}, "identificationModule"=>{"nctId"=>"NCT06233136", "briefTitle"=>"Effect of Leg Pedalling Exercise From Inclined Position", "organization"=>{"class"=>"OTHER", "fullName"=>"Cairo University"}, "officialTitle"=>"Effect of Leg Pedalling Exercise From Inclined Position on Functional Ability and Trunk Control in Children With Diplegic Cerebral Palsy", "orgStudyIdInfo"=>{"id"=>"P.T.REC/012/004085"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Leg Pedalling exercise and designed physical therapy program", "description"=>"Each child in the experimental group will be positioned in semi-reclined position with 45 degree trunk flexion during the application of cycling Sessions will be 30 minutes per session, three times per week, for two successive months The designed physical therapy program It will be applied for all participated children in both groups. It includes;\n\n1. Flexibility exercises\n2. Static and dynamic balance exercises\n3. Functional training Sessions will be 45 minutes per session, three times per week, for two successive month", "interventionNames"=>["Device: Leg pedalling exercise", "Other: The designed physical therapy program"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Designed physical therapy program", "description"=>"The designed physical therapy program It will be applied for all participated children in both groups. It includes;\n\n1. Flexibility exercises\n2. Static and dynamic balance exercises\n3. Functional training Sessions will be 45 minutes per session, three times per week, for two successive month", "interventionNames"=>["Other: The designed physical therapy program"]}], "interventions"=>[{"name"=>"Leg pedalling exercise", "type"=>"DEVICE", "otherNames"=>["Leg ergometer"], "description"=>"Each child in the experimental group will be positioned in inclined position and will cycle through the range of motion under the supervision of the researcher", "armGroupLabels"=>["Leg Pedalling exercise and designed physical therapy program"]}, {"name"=>"The designed physical therapy program", "type"=>"OTHER", "otherNames"=>["Traditional physical therapy program"], "description"=>"It applied for all participated children in both groups. It includes;\n\n1. Flexibility exercises\n2. Static and dynamic balance\n3. Functional training exercises", "armGroupLabels"=>["Designed physical therapy program", "Leg Pedalling exercise and designed physical therapy program"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"12613", "city"=>"DOkki", "state"=>"Giza", "country"=>"Egypt", "facility"=>"Faculty of physical therapy cairo University", "geoPoint"=>{"lat"=>30.03823, "lon"=>31.2113}}], "overallOfficials"=>[{"name"=>"NANEES E Mohamed, Phd", "role"=>"STUDY_DIRECTOR", "affiliation"=>"Professor"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Cairo University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Scientific researcher", "investigatorFullName"=>"Alaa Bahgat mahmoud Hasan", "investigatorAffiliation"=>"Cairo University"}}}}
