Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-25 @ 9:01 PM
Study NCT ID:
NCT05878756
Status:
COMPLETED
Last Update Posted:
2023-05-30
First Post:
2023-05-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Additional Functional Strength Training on Mobility in Children With Hemiplegic Cerebral Palsy
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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-26', 'studyFirstSubmitDate': '2023-05-19', 'studyFirstSubmitQcDate': '2023-05-19', 'lastUpdatePostDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gross Motor Function Measure (GMFM)', 'timeFrame': 'Data was collected at Baseline and after 4 weeks', 'description': 'GMFM is used to evaluate change that occurs over time in the gross motor function of children with cerebral palsy.'}, {'measure': 'Gross Motor Function Classification System (GMFCS)', 'timeFrame': 'Data was collected at Baseline and after 4 weeks', 'description': "The GMFCS, or Gross Motor Function Classification System, is a five-level classification that differentiates children with cerebral palsy based on the child's current gross motor abilities, limitations in gross motor function, and need for assistive technology and wheeled mobility."}], 'secondaryOutcomes': [{'measure': 'Five time sit to stand (FTSST).', 'timeFrame': 'Data was collected at Baseline and after 4 weeks', 'description': 'Used to asses functional lower extremity strength, transitional movements, balance, and fall risk'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cerebral palsy', 'Functional strength training', 'Mobility', 'GMFC', 'GMFM'], 'conditions': ['Hemiplegic Cerebral Palsy', 'Mobility']}, 'descriptionModule': {'briefSummary': 'The randomized control trail was to determine the effects of additional functional Strength Training on mobility in Children with Hemiplegic Cerebral Palsy.', 'detailedDescription': 'The aim of functional physiotherapy is to train the child by emphasizing him to learn motor abilities. These motor abilities are those that are thought to be though either by children with cerebral palsy or their parents. Functional activities are learned by the repetitive practice of goal-oriented tasks in a given functional situation. This approach instead of focusing on normality, it focuses on functionality. In this way, it is very necessary for the child to practice a given task functionally rather than normally.No studies have been done to improve mobility and strength in lower limb in children with hemiplegia cerebral palsy. So for this reason, this study is conducted to investigate the effects of additional functional Strength Training on mobility in Children with Hemiplegic Cerebral Palsy.In this way we can make these children an active participant of the society.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nchildren who didnot use the assistive device children who follow the commands children who did not treated in any other rehabilitation center\n\nExclusion Criteria:\n\nchildren with any other diagnosis other than CP children with fixed contractures children underwent surgery children who received Botulinum Toxin'}, 'identificationModule': {'nctId': 'NCT05878756', 'briefTitle': 'Effects of Additional Functional Strength Training on Mobility in Children With Hemiplegic Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Health Education Research Foundation (HERF)'}, 'officialTitle': 'Effects of Additional Functional Strength Training on Mobility in Children With Hemiplegic Cerebral Palsy,A Randomized Control Trail', 'orgStudyIdInfo': {'id': 'YIRS/1666'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Functional strength training', 'description': 'With conventional therapy,the ten tasks were STS, one leg standing, weight shifting(from one side of body to other), step-ups, lateral step-ups, squatting against wall, picking an object from standing position, walking forward, walking backward and kicking the ball preform from the patient 5 days per week for 4 weeks.', 'interventionNames': ['Other: Functional Strength Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional therapy', 'description': 'passive and active range of motion exercises,Stretching and strengthening exercise 5 days per week for 4 weeks.', 'interventionNames': ['Other: Functional Strength Training']}], 'interventions': [{'name': 'Functional Strength Training', 'type': 'OTHER', 'otherNames': ['conventional therapy'], 'description': 'In addition to conventional therapy, experimental group was also given functional strength training program. Functional strength training was given as home program consisting of ten tasks.The ten tasks were STS, one leg standing, weight shifting(from one side of body to other), step-ups, lateral step-ups, squatting against wall, picking an object from standing position, walking forward, walking backward and kicking the ball.', 'armGroupLabels': ['Conventional therapy', 'Functional strength training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45400', 'city': 'Islamabad', 'country': 'Pakistan', 'facility': 'Yusra Institute of Rehablitation Science', 'geoPoint': {'lat': 33.72148, 'lon': 73.04329}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Health Education Research Foundation (HERF)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Mamoona Tasleem Afzal', 'investigatorFullName': 'Mamoona Tasleem Afzal', 'investigatorAffiliation': 'Health Education Research Foundation (HERF)'}}}}