Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-25 @ 11:47 PM
Study NCT ID:
NCT05162092
Status:
UNKNOWN
Last Update Posted:
2021-12-17
First Post:
2021-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Vestibular Stimulation on Motor Function and Balance in Children With Hypotonic 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': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'double (care provider ,outcome assessor)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'study participants will be randomized in two groups,conventional physiotherapy group and intervention group'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 82}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2022-03-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-16', 'studyFirstSubmitDate': '2021-11-16', 'studyFirstSubmitQcDate': '2021-12-16', 'lastUpdatePostDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gross motor', 'timeFrame': '5 weeks', 'description': 'A motor skill is a function, which involves precise movement of muscles with the intent to perform a specific act. Most purposeful movement requires the ability to "feel" or sense what one\'s muscles are doing as they perform the act. To measure the gross motor, gross motor function classification system is used. Gross motor function measure: The gross motor skill (sitting walking) of children and young people with cerebral palsy can be categorized into different level using a tool called gross motor function classification scale. Gross motor function scale has total of five levels. Level 1 is the lowest while level 5 is the highest. Higher level means worst outcome'}, {'measure': 'Balance:', 'timeFrame': '5 weeks', 'description': 'A biological system that enables us to know where our bodies are in the environment and to maintain a desired position. Normal balance depends on information from the inner ear, other senses (such as sight and touch) and muscle movement. To measure the balance, pediatric balance scale is used. Pediatric Balance Scale: The pediatric balance scale is modified version of Berg Balance that is used to assess functional balance skill in school-aged children they have 14 components and a total of 56 score. The minimum score is 0 and 56 is the maximum score. Higher score means good outcome'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vestibular stimulation', 'motor function', 'balance'], 'conditions': ['Hypotonic Cerebral Palsy']}, 'descriptionModule': {'briefSummary': 'my study base on 2groups with total sample size 68 patients .group A conventional physiotherapy group in which the duration of session is 30 mints with 5 mints rest .include soft tissue elogation of tight muscles,lowerlimb resistance exercise,movement transitions balance board standing walking and stair climbing.for group b (conventional physiotherapy and vestibular stimulation exercises)30 mints with 10 mints rest.same physiotherpy exercise re given with vestibular stimulation exercises include swinging in standing in all diection,trampoline jump,rocking movement in rocking chair gaze stabilization exercises and visual pursuit exercises', 'detailedDescription': 'my study base on 2groups with total sample size 68 patients .group A conventional physiotherapy group in which the duration of session is 30 mints with 5 mints rest .include soft tissue elogation of tight muscles,lowerlimb resistance exercise,movement transitions balance board standing walking and stair climbing.for group b (conventional physiotherapy and vestibular stimulation exercises)30 mints with 10 mints rest.same physiotherpy exercise re given with vestibular stimulation exercises include swinging in standing in all diection,trampoline jump,rocking movement in rocking chair gaze stabilization exercises and visual pursuit exercises under supervisio. and use 2 scales,pediatric balance scale and gross motor scale re used for taking data .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age range from 5-10 years.\n* both male/female\n* have good head control\n* hypotonic cerebral palsy\n* able to maintained ring sitting position\n\nExclusion Criteria:\n\n* children will not respond to visual and auditory stimuli due to blindness or deafness or sever mental retardation\n* children with un controlled convulsion or vp shunt\n* children with severe medical problems children with orthopedic condition'}, 'identificationModule': {'nctId': 'NCT05162092', 'briefTitle': 'Effects of Vestibular Stimulation on Motor Function and Balance in Children With Hypotonic Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'University of Lahore'}, 'officialTitle': 'Effects of Vestibular Stimulation on Motor Function and Balance in Children With Hypotonic Cerebral Palsy', 'orgStudyIdInfo': {'id': '893'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'training duration for each session is 30 mints with 5 mints rest and it includes passive soft tissue elogation of tight muscles,lower limb resistance exercises,movement transition,balance board standing ,walking and stair climbing', 'interventionNames': ['Other: Conventional physiotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'It included passive soft tissue elongation of tight muscles,lower limb resistance exercises,movement transition,balance board standing ,walking and stair climbing and Vestibular Stimulation exercises such as Swinging in standing in all directions, trampoline jumps, rocking movement in rocking chair, gaze stabilization exercises and visual pursuit exercises under supervision.', 'interventionNames': ['Other: Vestibular stimulation with conventional physiotherapy']}], 'interventions': [{'name': 'Conventional physiotherapy', 'type': 'OTHER', 'description': 'Participants will be given Conventional Physiotherapy. It included Passive Soft tissue elongation of tight muscles, Lower limb resistance exercises, Movement transitions, balance board and foam board standing, walking and stair climbing.', 'armGroupLabels': ['Group A']}, {'name': 'Vestibular stimulation with conventional physiotherapy', 'type': 'OTHER', 'description': 'Participants in group B will be given conventional physiotherapy and vestibular stimulation exercises. It included conventional is same as given to the conventional and Vestibular Stimulation', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lahore', 'state': 'Punjab Province', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Mahwish Zulfiqar, MS MSK PT', 'role': 'CONTACT', 'phone': '03355077906'}], 'facility': 'Mahwash Zulfiqar', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'centralContacts': [{'name': 'Mahwash zulfiqar Khan, msptn', 'role': 'CONTACT', 'email': 'zulfiqar1991khan@gmail.com', 'phone': '03355077906'}], 'overallOfficials': [{'name': 'bilal umer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Lahore'}, {'name': 'anam naz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Lahore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Lahore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}