Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT04694118
Status:
UNKNOWN
Last Update Posted:
2021-01-06
First Post:
2021-01-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of the Effectiveness of Walking Back Exercises and Rebound Therapy in Cerebral Palsy Rehabilitation
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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomise controlled clinical trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-05', 'studyFirstSubmitDate': '2021-01-01', 'studyFirstSubmitQcDate': '2021-01-01', 'lastUpdatePostDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in muscle volume', 'timeFrame': 'one measurement at the beginning of the study, second measurement 8 weeks later, 3rd measurement at 12th week following', 'description': 'ultrasonic imaging'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cerebral palsy,', 'neurodevelopmental therapy'], 'conditions': ['Cerebral Palsy, Spastic']}, 'descriptionModule': {'briefSummary': 'Purpose of the study:\n\nTo investigate the effect of walking back exercises and rebound therapy on muscle strength, functionality, balance and aerobic capacity in children with CP Implication for rehabilitation:Determining the effects of rehabilitative interventions (back and forth walking exercises and rebound therapy) to be applied in children with CP with objective measurement methods (muscle US, tetrax balance system) and evaluating the effects of the results on functionality and respiratory parameters', 'detailedDescription': 'Inclusion Criteria:\n\nBeing diagnosed with SP To be in the age range of 6-15 years, where effective communication can be provided in evaluation and treatment processes and when walking begins to mature Having adequate communication skills Being on level I or level II according to GMFM No impairment in visual functions in terms of not affecting postural control responses, Children with family consent\n\nStudy design:\n\nApplication of the evaluation methods specified at the beginning of the study to all 30 patients with CP who were randomly divided into 2 groups.\n\nRe-evaluations were planned 8 weeks after the first evaluation of all cases who were continuing with structured neurodevelopmental treatment programs. In addition to the ongoing structured neurodevelopmental treatment programs; Group 1: 12 weeks / 3 days 20 minutes walking back exercises on normal ground, Group 2: Rebound therapy exercises, which are arranged according to the functional levels of the cases, will be applied in 12 weeks / 3 days for 20 minutes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being diagnosed with hemiparetic SP To be in the age range of 6-15 years, where effective communication can be provided in evaluation and treatment processes and when walking begins to mature Having adequate communication skills Being on level I or level II according to KMFSS No impairment in visual functions in terms of not affecting postural control responses, Children with family consent\n\nExclusion Criteria:\n\n* Orthopedic surgery and / or botulinum toxin-A application for the lower extremity in the last 6 months Being at level III, level IV or level V according to KMFSS Severe convulsion situations that cannot be controlled with drugs Presence of a medical condition that prevents participation in the study Congenital malformation conditions accompanying CP'}, 'identificationModule': {'nctId': 'NCT04694118', 'briefTitle': 'Comparison of the Effectiveness of Walking Back Exercises and Rebound Therapy in Cerebral Palsy Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Medipol University Hospital'}, 'officialTitle': 'Comparison of the Effectiveness of Walking Back Exercises and Rebound Therapy in Cerebral Palsy Rehabilitation', 'orgStudyIdInfo': {'id': '10840098-604.01.01-E.66352'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '15 hemiparetic cerebral palsy,walking back group', 'description': 'GMFM I or II degreed 6-15 age range hemiparetic cerebral palsy', 'interventionNames': ['Other: rebound therapy']}, {'type': 'EXPERIMENTAL', 'label': '15 hemiparetic cerebral palsy,rebound therapy group', 'description': 'GMFM I or II degreed 6-15 age range hemiparetic cerebral palsy', 'interventionNames': ['Other: rebound therapy']}], 'interventions': [{'name': 'rebound therapy', 'type': 'OTHER', 'otherNames': ['walking back exercise'], 'description': '3 days a week in 12 weeks', 'armGroupLabels': ['15 hemiparetic cerebral palsy,rebound therapy group', '15 hemiparetic cerebral palsy,walking back group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'state': 'Uskudar', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'ülkü atasoy, msc.pt', 'role': 'CONTACT', 'email': 'ulkuatasoy2017@gmail.com', 'phone': '+905435796261'}], 'facility': 'Umran medical center', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Istanbul', 'state': 'Ümraniye', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'ulku atasoy, msc.pt', 'role': 'CONTACT', 'email': 'ulkuatasoy2017@gmail.com', 'phone': '+905435796261'}], 'facility': 'Ulku Atasoy', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'devrim tarakcı, assoc.prof.', 'role': 'CONTACT', 'email': 'dtarakci@medipol.edu.tr', 'phone': '4448544', 'phoneExt': '1890'}], 'overallOfficials': [{'name': 'ulku atasoy, msc.pt', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PhD student'}]}, 'ipdSharingStatementModule': {'url': 'https://pubmed.ncbi.nlm.nih.gov/', 'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'starting 6 months after publication).', 'ipdSharing': 'YES', 'description': 'all IPD that underlie results in a publication', 'accessCriteria': 'Users and editors with journal memberships published for pubmed users'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Medipol University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Msc.physiotherapist', 'investigatorFullName': 'ulkuatasoy2017', 'investigatorAffiliation': 'Istanbul Medipol University Hospital'}}}}