Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT07176858
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-16
First Post:
2025-09-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
BRAIN GYM EXERCISES and 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': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-12', 'studyFirstSubmitDate': '2025-09-04', 'studyFirstSubmitQcDate': '2025-09-12', 'lastUpdatePostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cognitive functions will be measured by computer-based RehaCom software. It is a valid and reliable tool. higher score indicate worse results', 'timeFrame': '3 month'}, {'measure': 'The quality of life of all children will be assessed by pediatric quality of life scale which is a valid and reliable scale to assess quality of life in CP children. higher scores indicate better results. raw scores range from 0 to 100', 'timeFrame': '3 month'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['brain gym exercises', 'cognitive function', 'cerebral palsy'], 'conditions': ['Cerebral Palsy']}, 'descriptionModule': {'briefSummary': 'Brain gym is a series of exercises developed to enhance learning by improving cognitive function and fostering a stronger mind-body connection. It uses physical and mental techniques to stimulate both hemispheres of the brain. This approach is rooted in kinesiology and applied neuroscience, fields that study the relationship between bodily movements and brain activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. A diagnosis of spastic hemiplegic CP\n2. Degree of spasticity ranges from 1 and 1+, according to modified Ashworth scale (MAS)\n3. The age of the selected children will range from 6 to 8 years old.\n4. Children are levels I and II according to GMFCS\n\nExclusion Criteria:\n\n1 - Children with visual or auditory problems. 2. Children with severe intellectual disability (IQ less than 65 according to Stanford Binet intelligence scale).\n\n3\\. Children have been injected with Botox injection or have done surgery in the last 6 months'}, 'identificationModule': {'nctId': 'NCT07176858', 'briefTitle': 'BRAIN GYM EXERCISES and CEREBRAL PALSY', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'EFFECT OF BRAIN GYM EXERCISES ON FUNCTIONAL ABILITIES IN CHILDREN WITH CEREBRAL PALSY', 'orgStudyIdInfo': {'id': 'P.T.REC/012/004633'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'brain gym exercises and designed physical therapy program', 'interventionNames': ['Other: brain gym exercise']}, {'type': 'EXPERIMENTAL', 'label': 'designed physical therapy program', 'interventionNames': ['Other: specially designed pt program']}], 'interventions': [{'name': 'brain gym exercise', 'type': 'OTHER', 'description': 'specially designed physical therapy program in addition to brain gym exercises for 60 min (30 min designed P.T program and other 30 min for brain gym exercises), 3 sessions/ week for 3 successive months. eight Brain Gym exercises will be selected: Cross Crawl, Lazy 8s, Hook-ups, Brain Buttons, The Elephant, The Owl, Neck Rolls, Double Doodle', 'armGroupLabels': ['brain gym exercises and designed physical therapy program']}, {'name': 'specially designed pt program', 'type': 'OTHER', 'description': 'conventional physical therapy program including reinforcement of the normal motor development, reflex inhibiting patterns, postural reaction, stretching, strengthening exercises, and gait training was applied to children in the control group', 'armGroupLabels': ['designed physical therapy program']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Alaa AL-Nemr', 'role': 'CONTACT', 'email': 'alaaalnemr28@gmail.com', 'phone': '+201003727467'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor at faculty of physical therapy, Cairo university', 'investigatorFullName': 'Alaa Fahmy Hassan Al Nemr', 'investigatorAffiliation': 'Cairo University'}}}}