Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2025-12-28 @ 9:46 PM
Study NCT ID:
NCT05331703
Status:
UNKNOWN
Last Update Posted:
2022-04-18
First Post:
2022-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality Versus Mirror Therapy on Balance and Muscle Strength in Children With Hemiplegic Cerebral Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-22', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2023-12-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-13', 'studyFirstSubmitDate': '2022-03-28', 'studyFirstSubmitQcDate': '2022-04-13', 'lastUpdatePostDateStruct': {'date': '2022-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biodex balance system', 'timeFrame': '3 months', 'description': 'The Biodex balance System to measures postural stability under dynamic stress.'}, {'measure': 'Hand held dynamometer', 'timeFrame': '3 months', 'description': 'The hand held dynamometry to measure muscle strength of non-disabled children'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rehabilitation']}, 'descriptionModule': {'briefSummary': 'Previous research has demonstrated balance deficits ranging from 28%-43% depending on the nature of the balance task in individuals with CP compared to controls (Kenis-Coskun et al., 2016). As balance is critical for underlying normal movement, improvements in static and dynamic balance are important goals in rehabilitation for ambulatory children with CP (Saether et al., 2013).\n\nBalance deficits are among the symptoms that having a more profound impact on motor function and quality of life inn with CP children (Lai et al., 2017). Poor balance reduces the ability to perform gait-related activities and increases the risk of falling, which, in turn, limits participation in daily activities, including sports and physical activities (Usuba et al., 2015).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Their ages will range from 6 to 10 years old.\n* The degree of spasticity will range from 1+ to 2 grades according to Modified Ashworth scale (NUMANO and Günel, 2011) (Appendix II).\n* They will be on level I and II on Gross Motor Function Classification System (GMFCS) (Palisano et al., 2008) (Appendix III).\n* Their heights will be one meter or more.\n* They will be able to follow the verbal commands or instructions.\n\nExclusion Criteria:\n\n* Severe visual or auditory problems.\n* Epilepsy.\n* History of surgical interference in lower limbs.\n* Botulinum toxin injections of the lower limbs during the previous six'}, 'identificationModule': {'nctId': 'NCT05331703', 'briefTitle': 'Virtual Reality Versus Mirror Therapy on Balance and Muscle Strength in Children With Hemiplegic Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'October 6 University'}, 'officialTitle': 'Virtual Reality Versus Mirror Therapy on Balance and Muscle Strength in Children With Hemiplegic Cerebral Palsy', 'orgStudyIdInfo': {'id': 'P.T.REC/012/0035A342'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group A', 'description': 'will receive a designed physical therapy program in addition to program of virtual reality', 'interventionNames': ['Other: designed physical therapy program in addition to program of virtual reality.']}, {'type': 'EXPERIMENTAL', 'label': 'group B', 'description': 'will receive a designed physical therapy program in addition to program of mirror therapy.', 'interventionNames': ['Other: designed physical therapy program in addition to program of mirror therapy.']}], 'interventions': [{'name': 'designed physical therapy program in addition to program of virtual reality.', 'type': 'OTHER', 'description': 'physical therapy program in addition to program of virtual reality.', 'armGroupLabels': ['group A']}, {'name': 'designed physical therapy program in addition to program of mirror therapy.', 'type': 'OTHER', 'description': 'physical therapy program in addition to program of mirror therapy.', 'armGroupLabels': ['group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8124', 'city': 'Cairo', 'state': 'October', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'emad mohamed, phd', 'role': 'CONTACT', 'email': 'omdamohamed9111@gmail.com', 'phone': '01146808839'}], 'facility': 'Emad Eldin', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'October 6 University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor at faculty of physical therapy at October 6 university', 'investigatorFullName': 'samar salem', 'investigatorAffiliation': 'October 6 University'}}}}