Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2026-03-04 @ 8:38 PM
Study NCT ID:
NCT03136432
Status:
UNKNOWN
Last Update Posted:
2018-09-28
First Post:
2017-04-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Determinants of the 6 Minute Walk Test in Cerebral Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2019-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-27', 'studyFirstSubmitDate': '2017-04-25', 'studyFirstSubmitQcDate': '2017-04-27', 'lastUpdatePostDateStruct': {'date': '2018-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional exercise capacity', 'timeFrame': '20 minutes', 'description': '6 minute walk test'}], 'secondaryOutcomes': [{'measure': 'Respiratory muscle strength', 'timeFrame': '20 minutes', 'description': 'Mouth pressure device'}, {'measure': 'Activities of daily living using with Pediatric Evaluation of Disability Inventory', 'timeFrame': '30 minutes', 'description': 'PEDI scale'}, {'measure': 'Quality of life', 'timeFrame': '30 minutes', 'description': 'CPQOL scale'}, {'measure': 'Change in trunk control over time assessed with Trunk Control Measurement Scale', 'timeFrame': '20 minutes', 'description': 'Assessing change in trunk control'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cerebral Palsy', 'Functional Exercise Capacity', 'Quality of Life'], 'conditions': ['Cerebral Palsy', 'Exercise']}, 'descriptionModule': {'briefSummary': 'Cerebral Palsy (CP) is a group of permanent disorders of movement and posture, generally accompanied by secondary musculoskeletal problems. Studies in literature showed taht children with CP supports a link between the levels of impairment and walking ability. The 6 Minute walk test is a standardized, self-placed walking test commonly used to access functional ability in children with cerebral palsy. While decreased exercise capacity has been identified in children with cerebral palsy, the clinical determinants of the 6MWT in this population have not been investigated yet. Thus the aim of this study is to investigate the relationship between 6 Minute walk test, quality of life, respiratory muscle strength,activities of daily living using with Pediatric Evaluation of Disability Inventory and trunk control.', 'detailedDescription': 'A convenience of children with hemiparetic and diplegia CP, 7-14 years, is going to recruited from Gazi University, Faculty of Health Science, Department of Physiotherapy and Rehabilitation. Every each of patients respiratory muscle strength will be evaluated using with electronic mouth pressure device, trunk control with using trunk control measurement scale, activities of daily living using with Pediatric Evaluation of Disability Inventory (PEDI), functional exercise capacity usin with six minute walk test (6MWT) and quality of life using with Cerebral Palsy Quality of Life Questionnaire (CPQOL).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '7 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children with cerebral palsy who can walk independently continuously for 6 minutes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 7-14 years\n* Diagnosed to spastic cerebral palsy\n* Gross Motor Function Classification System levels I or II.\n* Have no earlier interventions in the form of orthopaedic surgery or injection with botulinum toxin type A in the 6 month prior to baseline assessments\n* Child are able to demonstrate sufficient co-operation and cognitive understanding participating\n\nExclusion Criteria:\n\n* Active medical condition impairment (pneumonia etc.)\n* Do not accommodate the study\n* Do not want to attempt the study'}, 'identificationModule': {'nctId': 'NCT03136432', 'briefTitle': 'Clinical Determinants of the 6 Minute Walk Test in Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Gazi University'}, 'officialTitle': 'Clinical Determinants of the 6 Minute Walk Test in Children With Cerebral Palsy', 'orgStudyIdInfo': {'id': '8888'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children with cerebral palsy', 'description': 'Children with cerebral palsy, who can walking dependently and continuously for 6 minutes.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06500', 'city': 'Ankara', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Turkey (Türkiye)', 'facility': 'Gazi University, Faculty of Health and Sciences, Department of Physiotherapy and Rehabilitation Recruiting Ankara, Turkey, 06500', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '06500', 'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Muserref Nur Keles, Phd', 'role': 'CONTACT', 'email': 'muserref-1@hotmail.com', 'phone': '+905426622464'}], 'facility': 'Gazi University, Faculty of Health and Sciences, Department of Physiotherapy and Rehabilitation', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Muserref KELES, Msc', 'role': 'CONTACT', 'email': 'muserref-1@hotmail.com', 'phone': '+905426622464'}], 'overallOfficials': [{'name': 'Bulent Elbasan, Phd', 'role': 'STUDY_CHAIR', 'affiliation': 'Gazi University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'we have not decided yet'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gazi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant', 'investigatorFullName': 'Muserrefe Nur Keles', 'investigatorAffiliation': 'Gazi University'}}}}