Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-30 @ 3:04 PM
Study NCT ID:
NCT06398756
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Aquatic Therapy on Walking, Balance Functions, and Quality of Life in Children With 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': 'D000088543', 'term': 'Aquatic Therapy'}], 'ancestors': [{'id': 'D006875', 'term': 'Hydrotherapy'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'assignment'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-01', 'studyFirstSubmitDate': '2024-04-29', 'studyFirstSubmitQcDate': '2024-05-01', 'lastUpdatePostDateStruct': {'date': '2024-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified Ashworth Scale (MAS)', 'timeFrame': 'baseline, after 1 month and 3 month changes.', 'description': 'MAS 0: No increase in tone MAS 1: Minimal resistance or a catch and release at the end of the range of motion MAS 1+: Slight increase in tone, with minimal resistance felt in less than half of the range of motion MAS 2: Increased tone throughout most of the range of motion, but the joint can be easily moved MAS 3: Marked increase in tone, making passive movement difficult MAS 4: Rigidity in flexion or extension of the affected part'}, {'measure': 'Gross Motor Function Measurement', 'timeFrame': 'baseline, after 1 month and 3 month changes.', 'description': 'The Gross Motor Function Measurement (GMFM) is an assessment method used to determine the motor development level of children with cerebral palsy. Its purpose is to measure not just the quality of motor performance, but rather how much of the movement the child has accomplished.'}], 'secondaryOutcomes': [{'measure': 'Pediatric Balance Scale', 'timeFrame': 'baseline, after 1 month and 3 month changes.', 'description': 'The Pediatric Balance Scale (PBS)" is a functional balance measure that evaluates postural control while children perform activities they commonly engage in at home, school, and within the community. It consists of a 14-item scale, with each item scored from 0 to 4. The maximum score is 56.'}, {'measure': 'The Functional Reach Test', 'timeFrame': 'baseline, after 1 month and 3 month changes.', 'description': 'The Functional Reach Test is one of the dynamic balance assessment methods. It measures the maximum distance one can reach forward and sideways while standing upright.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['aquatic therapy', 'rehabiltation'], 'conditions': ['Cerebral Palsy']}, 'referencesModule': {'references': [{'pmid': '27967298', 'type': 'BACKGROUND', 'citation': 'Roostaei M, Baharlouei H, Azadi H, Fragala-Pinkham MA. Effects of Aquatic Intervention on Gross Motor Skills in Children with Cerebral Palsy: A Systematic Review. Phys Occup Ther Pediatr. 2017 Oct 20;37(5):496-515. doi: 10.1080/01942638.2016.1247938. Epub 2016 Dec 14.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to contribute to the rehabilitation program by comparing the effects of traditional rehabilitation methods and aquatherapy given in addition to these methods in patients with cerebral palsy. If the superiority of the rehabilitation program including aquatherapy is demonstrated, evidence will be provided for its more widespread use.', 'detailedDescription': 'The participants will be divided into two groups as the study group and the control group. The study group will receive an aquatherapy rehabilitation program in addition to the conventional rehabilitation program, while the control group will only receive the conventional rehabilitation program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Having a diagnosis of Hemiplegic Type or Diplegic Type Cerebral Palsy\n2. Being between the ages of 3 and 16\n3. Being at GMFCS levels I, II, and III\n4. Having sufficient cognitive abilities such as understanding simple instructions, following them, and performing requested tasks\n5. Parents and patients aged ≥ 9 agreeing to participate in the research\n\nExclusion Criteria:\n\n1. Experiencing uncontrolled seizures\n2. Having serious learning difficulties, behavioral problems, skin lesions, visual and/or hearing impairments that could affect function and participation\n3. Active infection\n4. Incontinence'}, 'identificationModule': {'nctId': 'NCT06398756', 'briefTitle': 'The Impact of Aquatic Therapy on Walking, Balance Functions, and Quality of Life in Children With Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'The Impact of Aquatic Therapy on Walking, Balance Functions, and Quality of Life in Children With Cerebral Palsy', 'orgStudyIdInfo': {'id': '10026545'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'conventional rehabilitation', 'description': '17 cerebral palsy patients will be included in the conventional rehabilitation program.', 'interventionNames': ['Other: conventional rehabilitation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional rehabilitation and aquatic therapy', 'description': '17 cerebral palsy patients will be included in the conventional rehabilitation and aquatic therapy program.', 'interventionNames': ['Other: aquatic therapy']}], 'interventions': [{'name': 'conventional rehabilitation', 'type': 'OTHER', 'description': '17 patients with cerebral palsy meeting the criteria will undergo conventional rehabilitation', 'armGroupLabels': ['conventional rehabilitation']}, {'name': 'aquatic therapy', 'type': 'OTHER', 'description': '17 patients with cerebral palsy meeting the criteria will undergo convertional rehabilitation and aquatic therapy', 'armGroupLabels': ['conventional rehabilitation and aquatic therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06800', 'city': 'Ankara', 'state': 'Ankara, Bilkent-Çankaya', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Emel Turgut Varan, Medical Doctor', 'role': 'CONTACT', 'email': 'emeltrgtemel@gmail.com', 'phone': '+905466674562'}], 'facility': 'Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Özlem Yılmaz Taşdelen, Professor Doctor', 'role': 'CONTACT', 'email': 'dr.ozlemyilmaz@gmail.com', 'phone': '05056460390'}, {'name': 'Emel Turgut Varan, Medical Doctor', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Emel Turgut Varan, Medical Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara City Hospital Bilkent'}, {'name': 'Özlem Yılmaz Taşdelen, Professor Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ankara City Hospital Bilkent'}, {'name': 'Evren Yaşar, Professor Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Ankara City Hospital Bilkent'}, {'name': 'Hacer Han, Physical therapist', 'role': 'STUDY_CHAIR', 'affiliation': 'Ankara City Hospital Bilkent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'medical doctor', 'investigatorFullName': 'Emel TURGUT VARAN', 'investigatorAffiliation': 'Ankara City Hospital Bilkent'}}}}