Ignite Creation Date:
2025-12-24 @ 2:02 PM
Ignite Modification Date:
2025-12-31 @ 11:13 PM
Study NCT ID:
NCT06180395
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2023-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relation Between Bone Mineral Density, Gross Motor Function and Quality of Life In Children With Cerebral Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}], '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'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-05', 'studyFirstSubmitDate': '2023-12-05', 'studyFirstSubmitQcDate': '2023-12-21', 'lastUpdatePostDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dual-energy X-ray absorptiometry (DXA) scans', 'timeFrame': '1 day', 'description': 'Dual-energy X-ray absorptiometry (DXA) scans will be used to assess bone mineral density (BMD).'}, {'measure': 'Gross motor function measurement scale (GMFM)', 'timeFrame': '1 day', 'description': 'Gross motor function measurement scale (GMFM) will be used to assess gross motor function.'}, {'measure': 'Quality of Life Questionnaire for Children (CP QOL-Child)', 'timeFrame': '1 day', 'description': 'Quality of Life Questionnaire for Children (CP QOL-Child) will be used to assess quality of life (QOL).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebral Palsy', 'Bone Density, Low', 'Gross Motor Development Delay']}, 'descriptionModule': {'briefSummary': 'studying the relationship between Bone Mineral Density, Gross Motor Function and, Quality of Life with CP can provide valuable insights into the musculoskeletal consequences of motor impairments and guide interventions to improve bone health.\n\nStatement of the problem Is there a relation between Bone Mineral Density, Gross Motor Function and Quality of Life in children with CP ? Purpose of the study\n\nTo study the relationship between:\n\n1. Bone Mineral Density and Gross Motor Function in ambulant and non-ambulant CP children.\n2. Bone Mineral Density and Quality of Life in ambulant and non-ambulant CP children.\n3. Gross Motor Function and Quality of Life in ambulant and non-ambulant CP children.', 'detailedDescription': 'Cerebral palsy (CP) is primarily a neuromotor disorder that affects the development of movement, muscle tone and posture. The underlying pathophysiology is an injury to the developing brain in the prenatal through neonatal period. Although the initial neuro pathologic lesion is non-progressive, children with cerebral palsy may develop a range of secondary conditions over time that will variably affect their functional abilities. The prevalence of CP varies between 1.5 to more than 4 cases per 1,000 live births worldwide. The motor impairments associated with CP can range from mild to severe, affecting different muscle groups and leading to difficulties in activities of daily living and participation in social and recreational activities.\n\nChildren with CP often experience motor impairments that affect their gross motor function, leading to limitations in activities and participation. These motor impairments can also have a negative impact on bone health, resulting in reduced bone mineral density (BMD) and increased risk of skeletal complications.\n\nGross motor function (GMF) refers to the ability to perform coordinated movements using large muscle groups, such as walking, running, and jumping. It is a key aspect of physical ability and independence in daily activities for children with CP. Previous research has shown that gross motor function is closely associated with bone health in this population. However, further investigation is needed to explore the specific nature of this correlation and its implications for intervention strategies.\n\nGross motor function is commonly assessed using standardized tools such as the Gross Motor Function Classification System (GMFCS) or the Gross Motor Function Measure (GMFM). Quality of life is a multidimensional construct that encompasses physical, psychological, and social well-being. In the context of cerebral palsy, understanding the impact of gross motor function on quality of life is crucial for comprehensive care and intervention planning. Children with CP may face limitations in mobility, participation in activities, and social interactions, which can significantly affect their overall quality of life. Exploring the relationship between gross motor function and quality of life can provide valuable insights into the factors influencing the holistic well-being of children with CP.\n\nThe quality of life in children with CP is not only influenced by their motor function but also by their overall health and well-being. Bone health plays a crucial role in maintaining the physical abilities and independence of individuals, as well as their overall quality of life. Impaired bone health in children with CP can lead to limitations in mobility, increased pain, and reduced participation in activities, which can have a significant impact on their overall well-being.\n\nBone mineral density, on the other hand, is an important measure of bone strength and overall skeletal health. Children with CP often exhibit lower BMD compared to typically developing peers due to factors such as reduced weight-bearing activities, muscle weakness, altered biomechanics, limited mobility, and hormonal imbalances. This reduced BMD increases their susceptibility to fractures and skeletal deformities, further impacting their functional abilities and quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '7 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Seventy- five CP Children will be divided into two groups according to GMFCS:\n\n1. Group 1 (Ambulant ) consisted of 35 children with CP classified to level I, II and III according to GMFCS.\n2. Group 2 (Non-Ambulant ) consisted of 35 children with CP classified to level IV and V according to GMFCS.\n\nAll measured variables will be identified for children of both groups, then correlation between BMD, gross motor function and QoL will be determined.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Children with CP (spastic diplegia and quadriplegia).\n2. Their chronological ages will be ranged from 7 to 10 years.\n3. They will be selected from both genders.\n4. Their motor function will be at any Level according to GMFCS.\n5. Their body mass index (BMI ) will be normal.\n\nExclusion criteria\n\nChildren will be excluded from the study if they have any of the following :\n\n1. Underweight, Overweight or Obese.\n2. Epilepsy , kidney problems that make them taking hormonal treatments or drugs affect bone density or taking calcium, vitamin D, steroids during 6 months prior to the study.\n3. Fracture in the measurement areas.\n4. Hip Flexion deformity more than 30° when posed to measure.\n5. Internal metallic fixations in the measurement areas (neck of femur and lumber vertebra from L1-L4).\n6. Hyperthyroidism or Hypothyroidism.\n7. Hypotonia.'}, 'identificationModule': {'nctId': 'NCT06180395', 'briefTitle': 'Relation Between Bone Mineral Density, Gross Motor Function and Quality of Life In Children With Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Relation Between Bone Mineral Density, Gross Motor Function and Quality of Life In Children With Cerebral Palsy', 'orgStudyIdInfo': {'id': 'CairoU_STE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1 (Ambulant )', 'description': 'consisted of 37 children with CP classified to level I, II and III according to GMFCS., then:\n\n1. Dual-energy X-ray absorptiometry (DXA) scans will be used to assess bone mineral density (BMD).\n2. Gross motor function measurement scale (GMFM) will be used to assess gross motor function.\n3. Quality of Life Questionnaire for Children (CP QOL-Child) will be used to assess quality of life (QOL).', 'interventionNames': ['Other: Group 1']}, {'label': 'Group 2 (Non-Ambulant )', 'description': 'consisted of 38 children with CP classified to level IV and V according to GMFCS.then:\n\n1. Dual-energy X-ray absorptiometry (DXA) scans will be used to assess bone mineral density (BMD).\n2. Gross motor function measurement scale (GMFM) will be used to assess gross motor function.\n3. Quality of Life Questionnaire for Children (CP QOL-Child) will be used to assess quality of life (QOL).', 'interventionNames': ['Other: Group 2']}], 'interventions': [{'name': 'Group 1', 'type': 'OTHER', 'otherNames': ['Ambulant'], 'description': 'consisted of 37 children with CP classified to level I, II and III according to GMFCS., then:\n\nDual-energy X-ray absorptiometry (DXA) scans will be used to assess bone mineral density (BMD).\n\nGross motor function measurement scale (GMFM) will be used to assess gross motor function.\n\nQuality of Life Questionnaire for Children (CP QOL-Child) will be used to assess quality of life (QOL).', 'armGroupLabels': ['Group 1 (Ambulant )']}, {'name': 'Group 2', 'type': 'OTHER', 'otherNames': ['Non-Ambulant'], 'description': 'consisted of 38 children with CP classified to level IV and V according to GMFCS. then:\n\nDual-energy X-ray absorptiometry (DXA) scans will be used to assess bone mineral density (BMD).\n\nGross motor function measurement scale (GMFM) will be used to assess gross motor function.\n\nQuality of Life Questionnaire for Children (CP QOL-Child) will be used to assess quality of life (QOL).', 'armGroupLabels': ['Group 2 (Non-Ambulant )']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'shimaa Emara, M.Sc', 'role': 'CONTACT'}], 'facility': 'faculty of medicine , Cairo University', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'centralContacts': [{'name': 'Shimaa Talaat Emara', 'role': 'CONTACT', 'email': 'shimaaemara2015@gmail.com', 'phone': '01060279269'}, {'name': 'Alaa Fahmy AlNemr, PhD', 'role': 'CONTACT', 'email': 'alaaalnemr28@gmail.com', 'phone': '0 100 372 7467'}], 'overallOfficials': [{'name': 'Elham Elsayed Salem, professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Shimaa Talaat Elsayed Emara', 'investigatorAffiliation': 'Cairo University'}}}}