Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2025-12-29 @ 1:04 PM
Study NCT ID:
NCT06899035
Status:
RECRUITING
Last Update Posted:
2025-03-27
First Post:
2025-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Hydrotherapy 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': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'This is a single blind study, the control group will receive a home exercise program, while the intervention group will receive both a home exercise program and hydrotherapy. Outcome assessments will be conducted by an investigator who is blinded to group allocation.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'two groups: an intervention group and a control group'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-26', 'studyFirstSubmitDate': '2025-03-21', 'studyFirstSubmitQcDate': '2025-03-26', 'lastUpdatePostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Goal Attainment Scaling (GAS)', 'timeFrame': 'six weeks', 'description': "Goal Attainment Scaling is a method of scoring the extent to which patient's individual goals are achieved in the course of intervention. In effect, each patient has their own outcome measure but this is scored in a standardised way as to allow statistical analysis."}, {'measure': 'Pediatric Quality of Life Inventory (PedsQL).', 'timeFrame': 'six weeks', 'description': 'Pediatric Quality of Life Inventory is a standardized tool designed to measure health-related quality of life (HRQoL) in children and adolescents. It assesses the physical, emotional, social, and school functioning of children with various health conditions, including cerebral palsy.'}, {'measure': 'Child and Adolescent Scale of Participation (CASP).', 'timeFrame': 'six weeks', 'description': 'Child and Adolescent Scale of Participation is a standardized assessment tool used to measure the extent of participation of children and adolescents in daily life activities across various settings, such as home, school, and community. It is particularly useful for children with disabilities or developmental disorders, including cerebral palsy.'}, {'measure': 'Pediatric Functional Independence Measure (WeeFIM)', 'timeFrame': 'six weeks', 'description': "Pediatric Functional Independence Measure is a standardized tool used to assess functional independence in children with disabilities, including cerebral palsy. It evaluates a child's ability to perform daily activities and tracks their level of assistance required in different domains."}, {'measure': 'Gross Motor Function Classification System (GMFCS)', 'timeFrame': 'six weeks', 'description': 'The Gross Motor Function Classification System is a standardized tool used to classify gross motor function in children and adolescents with cerebral palsy. It categorizes mobility levels based on self-initiated movement, need for assistive devices, and functional limitations.'}, {'measure': 'Gross Motor Function Measure (GMFM-88)', 'timeFrame': 'six weeks', 'description': 'The Gross Motor Function Measure is a standardized clinical tool used to assess gross motor function in children with cerebral palsy and other motor impairments. It evaluates changes in motor abilities over time and helps guide rehabilitation planning.'}], 'primaryOutcomes': [{'measure': 'Pediatric Balance Scale', 'timeFrame': 'six weeks', 'description': 'The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills during tasks that mimic experiences of everyday living in school-aged children. The scale consists of 14 balance-related test items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.'}], 'secondaryOutcomes': [{'measure': 'Selective Control of Upper Extremity Scale (SCUES)', 'timeFrame': 'six weeks', 'description': 'Selective Control of Upper Extremity Scale is a clinical assessment tool used to evaluate selective motor control (SMC) in the upper extremities of individuals with neurological impairments, such as cerebral palsy. It is adapted from the Selective Control Assessment of the Lower Extremity (SCALE) and focuses on assessing isolated joint movements in the shoulder, elbow, forearm, wrist, and fingers while minimizing synergistic patterns or involuntary movements.'}, {'measure': 'Selective Control Assessment of the Lower Extremity (SCALE)', 'timeFrame': 'six weeks', 'description': 'Selective Control Assessment of the Lower Extremity is a clinical tool used to evaluate selective voluntary motor control (SVMC) in individuals with neuromotor disorders, such as cerebral palsy. It assesses the ability to perform isolated joint movements in the lower extremities without involuntary movements or abnormal muscle synergies.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hydrotherapy', 'rehabilitation', 'balance', 'selective motor control', 'cerebral palsy'], 'conditions': ['Cerebral Palsy Children']}, '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.'}, {'pmid': '19923974', 'type': 'BACKGROUND', 'citation': 'Retarekar R, Fragala-Pinkham MA, Townsend EL. Effects of aquatic aerobic exercise for a child with cerebral palsy: single-subject design. Pediatr Phys Ther. 2009 Winter;21(4):336-44. doi: 10.1097/PEP.0b013e3181beb039.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn the effects of hydrotherapy in children with cerebral palsy. It aims to answer if hydrotherapy is affective on balance and selective motor control of the children with cerebral palsy.', 'detailedDescription': 'Children diagnosed with cerebral palsy by a pediatric neurologist and followed up at the Pediatric Rehabilitation Outpatient Clinic of the Physical Medicine and Rehabilitation Department at Sağlık Bilimleri University Gaziosmanpaşa Training and Research Hospital, aged between 4 and 18 years, with a Gross Motor Function Classification System (GMFCS) level of 1-4, will be included in the study.\n\nPatients scheduled for hydrotherapy treatment will be enrolled in the study. The participants will be randomly assigned into two groups using the envelope randomization method. The first group will be the study group, while the second group will be the control group. The control group will receive hydrotherapy after the study is completed.\n\nDemographic data such as age, height, weight, and body mass index (BMI) of the included children will be recorded. Functional status will be assessed using the Gross Motor Function Classification System (GMFCS) and the Gross Motor Function Measure (GMFM-88) sections D and E. Balance will be evaluated with the Pediatric Balance Scale (PBS), selective motor control for upper and lower extremities with SCUES (Selective Control of Upper Extremity Scale) and SCALE (Selective Control Assessment of the Lower Extremity), activity with the Pediatric Functional Independence Measure (WeeFIM), participation with the Child and Adolescent Scale of Participation (CASP), quality of life with the Pediatric Quality of Life Inventory (PedsQL), and goal achievement with the Goal Attainment Scale (GAS).\n\nPatients in the study group will undergo individualized water-based exercises (including standing, balance, weight shifting, breathing exercises, range of motion, stretching, and strengthening exercises) under the supervision of an experienced physiotherapist, 2-3 times per week for six weeks. Additionally, routine conventional exercises will be continued daily for six weeks.\n\nPatients in the control group will continue passive, active, active-assisted, or resistance-based upper and lower extremity conventional exercises appropriate to their functional level and muscle strength. They will be instructed to perform these exercises 2-3 times per week, with each session lasting no more than 45 minutes, for six weeks.\n\nAssessments conducted at the beginning of the study will be repeated at the end of six weeks and one month after the completion of the intervention. The results will be compared accordingly.\n\n\\* Conventional exercise therapy consists of range of motion, stretching, and strengthening exercises applied to patients diagnosed with cerebral palsy.\n\nThis is a single-center, single-blind, prospective clinical study. A total of 36 patients, including 18 in the study group and 18 in the control group, are planned to be included between January 1, 2024, and September 15, 2025.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with Cerebral Palsy by a specialist physician\n* Aged between 4-18 years\n* Cooperative with physiotherapy applications\n* Gross Motor Function Classification System (GMFCS) levels 1-4\n* Willing to participate in the study and undergo assessments\n\nExclusion Criteria:\n\n* Mental retardation or insufficient cognitive function to comply with study assessments\n* GMFCS level 5\n* Presence of an intrathecal baclofen pump for spasticity treatment or history of soft tissue and/or bone surgery\n* Active infection or localized skin infection at the injection site\n* History of active seizures\n* Presence of contractures\n* Serious systemic disease that may prevent exercise participation\n* Injury and/or surgery within the last 6 months\n* Botulinum toxin injection within the last 6 months\n* Contraindications to hydrotherapy, including severe fear of water, behavioral problems, shortness of breath at rest, infection, incontinence, known chlorine allergy, open wounds, acute systemic illness, epilepsy, tracheostomy, permanent drains, immunodeficiency.'}, 'identificationModule': {'nctId': 'NCT06899035', 'briefTitle': 'Effects of Hydrotherapy in Children With Cerebral Palsy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Gaziosmanpasa Research and Education Hospital'}, 'officialTitle': 'Evaluation of the Effects of Hydrotherapy on Balance and Selective Motor Control in Children With Cerebral Palsy', 'orgStudyIdInfo': {'id': 'GaziosmanpasaTREH-FTR-MGDS-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'Patients in the study group will undergo individualized water-based exercises (including standing, balance, weight shifting, breathing exercises, range of motion, stretching, and strengthening exercises) under the supervision of an experienced physiotherapist, 2-3 times per week for six weeks. Additionally, routine conventional exercises will be continued daily for six weeks.', 'interventionNames': ['Other: Intervention Group (water-based and conventional exercise)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Patients in the control group will continue passive, active, active-assisted, or resistance-based upper and lower extremity conventional exercises appropriate to their functional level and muscle strength. They will be instructed to perform these exercises 2-3 times per week, with each session lasting no more than 45 minutes, for six weeks.', 'interventionNames': ['Other: control group (conventional exercise)']}], 'interventions': [{'name': 'Intervention Group (water-based and conventional exercise)', 'type': 'OTHER', 'description': 'Patients in the study group will undergo individualized water-based exercises (including standing, balance, weight shifting, breathing exercises, range of motion, stretching, and strengthening exercises) under the supervision of an experienced physiotherapist, 2-3 times per week for six weeks. Additionally, routine conventional exercises will be continued daily for six weeks.', 'armGroupLabels': ['Intervention Group']}, {'name': 'control group (conventional exercise)', 'type': 'OTHER', 'description': 'Patients in the control group will continue passive, active, active-assisted, or resistance-based upper and lower extremity conventional exercises appropriate to their functional level and muscle strength. They will be instructed to perform these exercises 2-3 times per week, with each session lasting no more than 45 minutes, for six weeks.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34255', 'city': 'Istanbul', 'state': 'Gaziosmanpasa', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Serap Seringeç Karabulut', 'role': 'CONTACT', 'email': 'serapseringec@hotmail.com', 'phone': '5057242669', 'phoneExt': '+90'}], 'facility': 'GaziosmanpasaTREH', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Melis Gökçe Dağbağ Sağlam', 'role': 'CONTACT', 'email': 'melisiel15@gmail.com', 'phone': '5362602519', 'phoneExt': '+90'}, {'name': 'Serap Seringeç Karabulut', 'role': 'CONTACT', 'email': 'serapseringec@hotmail.com', 'phone': '5057242669', 'phoneExt': '+90'}], 'overallOfficials': [{'name': 'Ebru Yılmaz Yalçınkaya', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gaziosmanpasa Research and Education Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gaziosmanpasa Research and Education Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Melis Gökçe Dağbağ', 'investigatorAffiliation': 'Gaziosmanpasa Research and Education Hospital'}}}}