Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT06646718
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-10-17
First Post:
2024-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect Of Closed Kinetic Chain On Hip Stability In Spastic Cerebral Palsy Post Selective Dorsal Rhizotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '* The study will include children (age 5-14years) post selective dorsal rhizotomy.\n* Children meeting the inclusion criteria will be randomly assigned to one of two groups:\n\n * Experimental Group: children in this group will receive closed kinetic chain.\n * Control Group: Patients in this group will receive Traditional physical therapy.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-10-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-15', 'studyFirstSubmitDate': '2024-10-14', 'studyFirstSubmitQcDate': '2024-10-15', 'lastUpdatePostDateStruct': {'date': '2024-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Isokinetic dynamometry:', 'timeFrame': '12 weeks', 'description': 'Isokinetic dynamometry testing is a device used within sports and exercise science as well as clinical testing environments that is used to evaluate joint torque. Isokinetic dynamometers are able to test the strength (torque) and power of different muscle groups.\n\nis a safe and reliable method accepted as the "gold standard" in the evaluation of muscle strength.\n\nIt will be used before and after intervention to measure muscle strength'}, {'measure': 'X-ray:', 'timeFrame': '12 weeks', 'description': 'used to assess the alignment of the hip joint, detect any abnormalities, and determine the degree of bone deformities or hip dislocation.\n\nWill be used before and after intervention to determine hip angles'}, {'measure': 'The Pediatric Balance Scale:', 'timeFrame': '12 weeks', 'description': 'The Pediatric Balance Scale (PBS), which is a modification of Berg Balance Scale (BBS) designed for children and adolescents aged 5 to 15 years, to assess functional balance abilities. The scale is composed of 14 items that are scored on a criterion-based 0 to 4 scale. The range of scores in the PBS is 0 to 56. each activity is rated on a five-point scale (0-4) so that the maximum score is 56. Patients who score 41 or higher are considered to be a low fall risk, those who score between 21 and 40 are considered to be moderate fall risks, and those who score below 20 are considered to be high fall risks. It will be completed in 15-20 minutes'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebral Palsy', 'Selective Dorsal Rhizotomy']}, 'descriptionModule': {'briefSummary': 'Purpose of the study:\n\nTo evaluate the effect of closed kinetic chain on hip stability after selective dorsal rhizotomy on spastic cerebral palsy.', 'detailedDescription': '* This is a prospective randomized controlled clinical trial, conducted at Kafr El sheikh Hospital.\n* Sixty-six children of both genders.\n* The study will include children (age 5-14years) post selective dorsal rhizotomy.\n* Children meeting the inclusion criteria will be randomly assigned to one of two groups:\n\n * Experimental Group: children in this group will receive closed kinetic chain.\n * Control Group: Patients in this group will receive Traditional physical therapy.\n* Randomization will be achieved using computer-generated random numbers to ensure an equal distribution of patients between the two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1-Patients will be aged from 5 to 14 years\n\n 2- will be included both genders post selective dorsal rhizotomy.\n\n 3- The GMFCS level I-II spastic diplegia, able to stand up from a chair independently and maintain standing for more than 5 seconds without falling.\n\n 4- Had not received any strength training program in the past 3 months before the study.\n\n 5- Able to attend physical therapy (PT) treatment at least three a week before and during this study.\n\nExclusion Criteria:\n\n* 1-have perceptual, cognitive, visual and auditory disorder.\n\n 2- botulinum toxin injection to the lower extremities within 6 Months.\n\n 3- Medical conditions that prevented children from participating in the exercises.\n\n 4- Previous lower extremity surgery, such as prior hamstring muscle Lengthening. 5- Existence of any orthopedic condition or any static hip, knee or ankle deformities.'}, 'identificationModule': {'nctId': 'NCT06646718', 'briefTitle': 'Effect Of Closed Kinetic Chain On Hip Stability In Spastic Cerebral Palsy Post Selective Dorsal Rhizotomy', 'organization': {'class': 'OTHER', 'fullName': 'Kafrelsheikh University'}, 'officialTitle': 'Effect Of Closed Kinetic Chain On Hip Stability In Spastic Cerebral Palsy Post Selective Dorsal Rhizotomy', 'orgStudyIdInfo': {'id': 'KFSIRB200-171'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '❖ Experimental Group: group A', 'description': 'Group A (study group): will include 33 children after selective dorsal rhizotomy surgery from both gender will be selected from the Outpatient Clinic. Able to attend physical therapy (PT) treatment at least three a week before and during this study. who will receive closed kinetic chain.', 'interventionNames': ['Procedure: Close kinetic chain exercise group']}, {'type': 'OTHER', 'label': '❖ Control Group:Group B', 'description': '●Group B (control group): will include 33 children who will receive Traditional physiotherapy. will include 33 children after selective dorsal rhizotomy surgery from both gender', 'interventionNames': ['Procedure: Traditional physical therapy.']}], 'interventions': [{'name': 'Close kinetic chain exercise group', 'type': 'PROCEDURE', 'otherNames': ['Experimental group intervention'], 'description': '●Close kinetic chain exercise group: group A will receive forward step-ups, lateral step-ups, squats, sit-to-stand, and stoop-and-recover exercises. session will be initiated with a 10 min warm-up period, including stretching of the major muscles and muscle groups, then 40 min different exercises and terminated with a 10 min cool-down period in the form of aerobic exercises.', 'armGroupLabels': ['❖ Experimental Group: group A']}, {'name': 'Traditional physical therapy.', 'type': 'PROCEDURE', 'otherNames': ['Control group intervention'], 'description': '●Traditional physiotherapy: group B will receive stretching for the lower extremity muscles, namely hip flexors and adductors, hamstrings, and calf muscles; and strengthening exercises for core muscles, hip extensors, flexors and abductors, internal and external rotators of the hip, flexors and extensors of the knee, ankle dorsi flexors, kneeling exercises, and standing and gait training', 'armGroupLabels': ['❖ Control Group:Group B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kafr ash Shaykh', 'state': 'Kafr Elsheikh', 'country': 'Egypt', 'facility': 'Faculty of physical therapy, Kafr elsheikh University', 'geoPoint': {'lat': 31.11174, 'lon': 30.93991}}], 'overallOfficials': [{'name': 'Abdelaziz Ali Sherief, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kafr elsheikh University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kafrelsheikh University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Shaza Salah Eldin Ahmed Mostafa Elabd', 'investigatorAffiliation': 'Kafrelsheikh University'}}}}