Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2025-12-25 @ 7:17 PM
Study NCT ID:
NCT05787132
Status:
UNKNOWN
Last Update Posted:
2023-04-03
First Post:
2023-03-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of the Balance Board and Perceptual Motor Therapy in Children With 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'], 'maskingDescription': 'This will be single blinded study. The data will be coded and the analyst will also be blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 88}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-31', 'studyFirstSubmitDate': '2023-03-15', 'studyFirstSubmitQcDate': '2023-03-15', 'lastUpdatePostDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gross Motor Function Measure Scale (GMFM 88)', 'timeFrame': 'Baseline', 'description': 'The GMFM is standardized tool for measuring the change in gross motor function in children with cerebral palsy. GMFM-88 is four-point ordinal scale (0-3) with 88 items categorized in to 5 dimensions such as: lying and rolling (17 items), sitting (20 items), crawling and kneeling (14 items), standing (13 items), and walking, running and jumping (24 items). the average score ranges from 0-100. Higher scores indicate better capacity. The GMFM-88 reliability values range from 0.87 to 0.99'}, {'measure': 'Gross Motor Function Measure Scale (GMFM 88)', 'timeFrame': '4th week', 'description': 'The GMFM is standardized tool for measuring the change in gross motor function in children with cerebral palsy. GMFM-88 is four-point ordinal scale (0-3) with 88 items categorized in to 5 dimensions such as: lying and rolling (17 items), sitting (20 items), crawling and kneeling (14 items), standing (13 items), and walking, running and jumping (24 items). the average score ranges from 0-100. Higher scores indicate better capacity. The GMFM-88 reliability values range from 0.87 to 0.99'}, {'measure': 'Gross Motor Function Measure Scale (GMFM 88)', 'timeFrame': '8th week', 'description': 'The GMFM is standardized tool for measuring the change in gross motor function in children with cerebral palsy. GMFM-88 is four-point ordinal scale (0-3) with 88 items categorized in to 5 dimensions such as: lying and rolling (17 items), sitting (20 items), crawling and kneeling (14 items), standing (13 items), and walking, running and jumping (24 items). the average score ranges from 0-100. Higher scores indicate better capacity. The GMFM-88 reliability values range from 0.87 to 0.99'}, {'measure': 'Gross Motor Function Measure Scale (GMFM 88)', 'timeFrame': '12th week', 'description': 'The GMFM is standardized tool for measuring the change in gross motor function in children with cerebral palsy. GMFM-88 is four-point ordinal scale (0-3) with 88 items categorized in to 5 dimensions such as: lying and rolling (17 items), sitting (20 items), crawling and kneeling (14 items), standing (13 items), and walking, running and jumping (24 items). the average score ranges from 0-100. Higher scores indicate better capacity. The GMFM-88 reliability values range from 0.87 to 0.99'}, {'measure': 'Trunk Control Motor Scale (TCMS)', 'timeFrame': 'Baseline', 'description': 'Trunk control motor scale consist of 15 items which are used to assess the sitting balance of trunk control during functional activities such as: (a) while static condition (b) while dynamic condition. TCMS is two, three and four-point ordinal scale with the total score ranges from 0 to 58'}, {'measure': 'Trunk Control Motor Scale (TCMS)', 'timeFrame': '4th week', 'description': 'Trunk control motor scale consist of 15 items which are used to assess the sitting balance of trunk control during functional activities such as: (a) while static condition (b) while dynamic condition. TCMS is two, three and four-point ordinal scale with the total score ranges from 0 to 58'}, {'measure': 'Trunk Control Motor Scale (TCMS)', 'timeFrame': '8th week', 'description': 'Trunk control motor scale consist of 15 items which are used to assess the sitting balance of trunk control during functional activities such as: (a) while static condition (b) while dynamic condition. TCMS is two, three and four-point ordinal scale with the total score ranges from 0 to 58'}, {'measure': 'Trunk Control Motor Scale (TCMS)', 'timeFrame': '12th week', 'description': 'Trunk control motor scale consist of 15 items which are used to assess the sitting balance of trunk control during functional activities such as: (a) while static condition (b) while dynamic condition. TCMS is two, three and four-point ordinal scale with the total score ranges from 0 to 58'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cerebral palsy', 'GMFC IV', 'GMFC V', 'Balance board', 'Perceptual motor therapy'], 'conditions': ['Cerebral Palsy']}, 'descriptionModule': {'briefSummary': 'Various studies have worked on the sitting balance of cerebral palsy (CP) with Gross Motor Function Classification System (GMFCS) level I-III with a sample greater than 30, there is no data available to compare the effect of a balance board and perceptual motor therapy to improve sitting in GMFCS level IV and V with a sample greater than 30. This study will add the authenticity to literature with a large sample size and affect the severity of the condition.', 'detailedDescription': 'This study will compare the effect of balance board therapy and Perceptual motor therapy to improve sitting in children with Cerebral palsy. Previous studies have worked on the sitting balance of cerebral palsy (CP) with Gross Motor Function Classification System (GMFCS) level I-III with a sample greater than 30, there is no data available to compare the effect of a balance board and perceptual motor therapy to improve sitting in GMFC level IV and V with a sample greater than 30. This study will add the authenticity to literature with large sample size and affect the severity of the condition. In addition, the patients with diagnosed Cerebral Palsy with GMFCS levels IV and V will be benefited from this study; an exercise program will help them to improve their sitting ability. A total of 88 Cerebral palsy patients will be included by dividing them into two groups (A, B). 1 hour of exercise session will be performed three times per week for 12 weeks with a total of 36 sessions. Both groups will receive 30 minutes of conventional physical therapy. In addition, group A will receive balance board therapy in the remaining 30 minutes while Group B will receive Perceptual motor therapy in the remaining 30 minutes. Data will be collected at baseline, at 4 weeks, at 8 weeks and at 12 weeks after intervention from both groups. The sitting balance will be measured by using Gross Motor Function Measure Scale (GMFM 88) and Trunk Control Motor Scale (TCMS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have been diagnosed with CP GMFC level IV and V\n* Both Male/Female\n* Participants with the age ranges from 1.5 years to 5 years\n\nExclusion Criteria:\n\n* Patients diagnosed with GMFC level I, II and III\n* Participants taking botulinum toxin\n* Participants diagnosed with auditory and visual impairments\n* Participants diagnosed with mental impairments/ unable to understand the commands\n* Participants diagnosed with any other comorbid conditions like (obesity, cardiovascular impairments)\n* Participants who are not willing to participate'}, 'identificationModule': {'nctId': 'NCT05787132', 'briefTitle': 'Comparison of the Balance Board and Perceptual Motor Therapy in Children With Cerebral Palsy.', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Comparison of the Balance Board and Perceptual Motor Therapy in Children With Cerebral Palsy.', 'orgStudyIdInfo': {'id': 'REC/ 01347 Bakhtawar Samejo'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A (Balance Board Therapy)', 'description': '30 minutes of Balance board therapy along with conventional physical therapy', 'interventionNames': ['Other: Balance Board therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Group B (Perceptual Motor Therapy)', 'description': '30 minutes of Perceptual Motor therapy along with conventional physical therapy', 'interventionNames': ['Other: Perceptual Motor therapy']}], 'interventions': [{'name': 'Balance Board therapy', 'type': 'OTHER', 'description': 'Balance board therapy will be performed. balance board therapy has been shown to improve the sitting balance in children with cerebral palsy', 'armGroupLabels': ['Group A (Balance Board Therapy)']}, {'name': 'Perceptual Motor therapy', 'type': 'OTHER', 'description': 'Perceptual motor therapy will be performed, it has been shown to improve dynamic sitting in children with cerebral palsy.', 'armGroupLabels': ['Group B (Perceptual Motor Therapy)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Karachi', 'state': 'Sindh', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Bakhtawar Samejo, DPT', 'role': 'CONTACT', 'email': 'bakhtawer.samejo@gmail.com', 'phone': '+923042923429'}], 'facility': 'Al-Umeed Rehabilitation Association', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'centralContacts': [{'name': 'Bakhtawar Samejo, MS-NMPT', 'role': 'CONTACT', 'email': 'bakhtawer.samejo@gmail.com', 'phone': '+923042923429'}], 'overallOfficials': [{'name': 'Imran Amjad, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}