Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2025-12-25 @ 7:48 PM
Study NCT ID:
NCT05348135
Status:
COMPLETED
Last Update Posted:
2022-04-27
First Post:
2022-03-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combined Cognitive and Functional Strength Training in Children With cp
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000091942', 'term': 'Cognitive Training'}], 'ancestors': [{'id': 'D000066530', 'term': 'Neurological Rehabilitation'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-03-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-20', 'studyFirstSubmitDate': '2022-03-12', 'studyFirstSubmitQcDate': '2022-04-20', 'lastUpdatePostDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in GMFM-88 measures', 'timeFrame': 'The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up', 'description': 'criterion-referenced scale that measure gross motor function in children with CP.'}, {'measure': 'change in attention / concentration measures', 'timeFrame': 'The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up', 'description': '* Computer based RehaCom software used to assess attention / concentration cognitive domain of function. It is clinically proven and evidence-based software.\n* minimum reaction time ( in seconds) of attention / concentration program was assessed'}, {'measure': 'change in figural memory measures', 'timeFrame': 'The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up', 'description': '* Computer based RehaCom software used to assess figural memory cognitive domain of function.It is clinically proven and evidence-based software.\n* minimum reaction time ( in seconds) of figural memory program was assessed'}, {'measure': 'change in reaction behavior measures', 'timeFrame': 'The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up', 'description': 'Computer based RehaCom software used to assess reaction behavior cognitive domain of function. It is clinically proven and evidence-based software.\n\n\\- minimum reaction time ( in seconds) of reaction behavior program was assessed'}, {'measure': 'change in logical reasoning measures', 'timeFrame': 'The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up', 'description': 'Computer based RehaCom software used to assess logical reasoning cognitive domain of function. It is clinically proven and evidence-based software.\n\n\\- minimum reaction time ( in seconds) of logical reasoning program was assessed'}], 'secondaryOutcomes': [{'measure': 'change in Five times sit to stand test (FTSST) measure', 'timeFrame': 'The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up', 'description': 'measure the time spent for completing five sequential sit to stand to sit cycles. It is a reliable and valid measure of functional muscle strength and balance in CP children.'}, {'measure': 'change in Timed up and go test (TUG)measure', 'timeFrame': 'The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up', 'description': 'A reliable and valid test used for assessing dynamic balance and functional mobility in the children.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diplegic Cerebral Palsy']}, 'descriptionModule': {'briefSummary': 'Cerebral palsy is primarily a disorder of movement and posture however; it often involves disorder of different aspects of cognitive function.', 'detailedDescription': 'This study evaluated the effect of FST and cognitive intervention and their combined effect on motor and cognitive functions in children with spastic diplegia. A convenient sample of spastic diplegic CP children, with their age ranging from 8 to 12 years were assigned randomly into four treatment groups'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronological age ranged from 8 to 12 years,\n* spasticity grade in affected lower limbs ranged between 1 + and 2 according to MAS\n* can follow instructions given to them,\n* their intelligence level ranged from 65 to 80 according to Stanford Binet intelligence scale, - -- their motor function ranged between Level II \\& III according to Gross Motor Functional Classification System Expanded and Revised (GMFCS E\\&R).\n\nExclusion Criteria:\n\n* children who had visual or auditory problems\n* children who took any medicine affecting alertness\n* fixed deformities in the joints of upper \\& lower limbs\n* any orthopedic surgery in lower limbs within 6 months before study\n* epileptic children.'}, 'identificationModule': {'nctId': 'NCT05348135', 'briefTitle': 'Combined Cognitive and Functional Strength Training in Children With cp', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Synergistic Effect of Functional Strength Training and Cognitive Intervention on Motor and Cognitive Functions in Children With Cerebral Palsy', 'orgStudyIdInfo': {'id': 'No:P.T.REC/012/003398'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Functional strength training', 'interventionNames': ['Other: functional strength training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cognitive training', 'interventionNames': ['Other: cognitive training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Combined treatment', 'interventionNames': ['Other: functional strength training', 'Other: cognitive training']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Conventional physical therapy', 'interventionNames': ['Other: conventional physical therapy']}], 'interventions': [{'name': 'functional strength training', 'type': 'OTHER', 'description': 'children in this group received FST. Each training session started with 10 minutes dynamic warm-up period and ended with 5 minutes cool down in the form of muscle stretching and aerobics. The warm up was followed by gait training in addition to 4 functional lower limb exercises; sit to stand exercise, forward/ lateral step-up exercise, half knee rise exercise, and bridging exercise.', 'armGroupLabels': ['Combined treatment', 'Functional strength training']}, {'name': 'cognitive training', 'type': 'OTHER', 'description': 'Children in this group received cognitive training by RehaCom cognitive rehabilitation software. Training was applied for four cognitive domains of function; attention / concentration, figural memory, reaction behavior and logical reasoning.', 'armGroupLabels': ['Cognitive training', 'Combined treatment']}, {'name': 'conventional physical therapy', 'type': 'OTHER', 'description': 'including reinforcement of normal motor development, reflex inhibiting patterns, balance exercises, stretching exercises and gait training', 'armGroupLabels': ['Conventional physical therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty Of Physical Therapy', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Alaa Fahmy Hassan Al Nemr', 'investigatorAffiliation': 'Cairo University'}}}}