Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-04-18 @ 6:55 AM
Study NCT ID:
NCT05313633
Status:
COMPLETED
Last Update Posted:
2024-11-18
First Post:
2022-03-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plyometric Exercises Versus Wii Training in Children with Unilateral 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009788', 'term': 'Occupational Therapy'}, {'id': 'D059385', 'term': 'Plyometric Exercise'}], 'ancestors': [{'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': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2024-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-15', 'studyFirstSubmitDate': '2022-03-07', 'studyFirstSubmitQcDate': '2022-03-29', 'lastUpdatePostDateStruct': {'date': '2024-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Upper extremity function', 'timeFrame': 'after 3 months of treatment', 'description': 'The quality of upper extremity skill test is a reliable and valid tool used to measure the motor function in children with cerebral palsy. The total scores for each domain percentage score range from zero to 100%'}, {'measure': 'Hand grip strength', 'timeFrame': 'after 3 months of treatment', 'description': 'The hand held dynamometer (Patterson Medical, Warrenville, IL, USA) is a valid and reliable tool to assess grip strength. Each child performs three trials and the mean will be recorded in kilogram for statistical analysis.'}], 'secondaryOutcomes': [{'measure': 'Range of motion', 'timeFrame': 'after 3 months of treatment', 'description': 'An electronic goniometer will be used for the measurements of ROM of the affected upper limb in order to accurately track progress in a rehabilitation program.\n\nShoulder flexion and abduction, elbow extension, forearm supination and wrist extension will be measured for all children before and after treatment'}, {'measure': 'Selective motor control', 'timeFrame': 'after 3 months of treatment', 'description': 'Test of arm selective control, a valid and reliable tool, will be used to measure selectivity of upper extremity with total score for each upper extremity is 16 and 32 for both tested upper extremities.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cerebral palsy', 'Unilateral Cerebral Palsy', 'hand grip strength', 'upper extremity function', 'range of motion', 'Wii training', 'plyometric exercises'], 'conditions': ['Sports Physical Therapy']}, 'descriptionModule': {'briefSummary': 'Plyometric training includes muscle contraction that moves rapidly from the eccentric to the concentric phase of movement while using proper biomechanics. It is an effective neuromuscular stimulus that can improve motor functions of children with cerebral palsy. In plyometric training, muscles exert maximum force in short intervals of time, with the goal of increasing power.\n\nCommercially available video games have been used for a wide range of clinical populations with generally positive clinical outcomes. They have been shown to be active enough to provide an increase in energy expenditure and physical activity in children with cerebral palsy. Furthermore, an early case study showed improvements in visual-perceptual processing, balance, and mobility in a child with cerebral palsy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 8-12 years;\n* able to understand and follow simple commands.\n\nExclusion Criteria:\n\n\\- severe uncontrolled seizures;'}, 'identificationModule': {'nctId': 'NCT05313633', 'briefTitle': 'Plyometric Exercises Versus Wii Training in Children with Unilateral Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Efficacy of Plyometric Exercises Versus Wii Training on Upper Extremity Function in Children with Unilateral Cerebral Palsy: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'plyometric training'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Wii group', 'description': 'Children in this group will receive a designed physical therapy and occupational therapy programs', 'interventionNames': ['Other: Occupational therapy', 'Other: Wii training']}, {'type': 'EXPERIMENTAL', 'label': 'plyometric group', 'description': 'Children in this group will receive a designed physical therapy and occupational therapy programs and plyometric training', 'interventionNames': ['Other: Occupational therapy', 'Other: Plyometric training']}], 'interventions': [{'name': 'Occupational therapy', 'type': 'OTHER', 'description': 'Both groups received a designed occupational therapy program for 30 minutes', 'armGroupLabels': ['Wii group', 'plyometric group']}, {'name': 'Plyometric training', 'type': 'OTHER', 'description': 'The designed plyometric training program basically focuses on upper extremity strength training and is developed according to the guidelines of the National Strength and Conditioning Association.', 'armGroupLabels': ['plyometric group']}, {'name': 'Wii training', 'type': 'OTHER', 'description': 'The dose of Wii training was 40 minutes, three times a week for 12 weeks which is an interactive motion-based device.', 'armGroupLabels': ['Wii group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'state': 'Giza Governorate', 'country': 'Egypt', 'facility': 'faculty of physical therapy, Cairo university', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'overallOfficials': [{'name': 'walaa A El-nabie, Phd', 'role': 'STUDY_CHAIR', 'affiliation': 'Cairo university, faculty of physical therapy'}, {'name': 'Hazem A Ali, Phd', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo university, faculty of physical therapy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principle investigator', 'investigatorFullName': 'Amira Mahmoud Abd-elmonem', 'investigatorAffiliation': 'Cairo University'}}}}