Ignite Creation Date:
2025-12-24 @ 12:18 PM
Ignite Modification Date:
2025-12-28 @ 4:58 PM
Study NCT ID:
NCT07188961
Status:
COMPLETED
Last Update Posted:
2025-09-23
First Post:
2025-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Kinesiologic Taping on Trunk Control and Balance in Children With Cerebral Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}, {'id': 'D009128', 'term': 'Muscle Spasticity'}], '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': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009122', 'term': 'Muscle Hypertonia'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-08-01', 'size': 1714580, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-09-16T07:04', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-05-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2025-08-16', 'studyFirstSubmitQcDate': '2025-09-16', 'lastUpdatePostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional Independence Measure for children (WeeFIM)', 'timeFrame': 'The study continued for 5 months. But we assessed Children in 0. week and 4. week.', 'description': 'There are a total of 18 questions. Scoring ranges from 1 to 7.a high score indicates increased independence'}, {'measure': 'Paediatric Berg Balance Scale (PBS)', 'timeFrame': 'The study continued for 5 months. But we assessed Children in 0. week and 4. week.', 'description': 'This scale consists of 14 sections. Each section is scored from 0 to 4. A high score indicates increased balance.'}, {'measure': 'Sitting Assessment Scale (SAS)', 'timeFrame': 'The study continued for 5 months. But we assessed Children in 0. week and 4. week.', 'description': 'It uses a scale of 1 (none), 2 (poor), 3 (moderate), and 4 (good) for children with cerebral palsy (CP). A high score indicates increased sitting balance.'}], 'secondaryOutcomes': [{'measure': 'Spastisity', 'timeFrame': 'The study continued for 5 months. But we assessed Children in 0. week and 4. week.', 'description': 'Spastisity was evaluated with Modified Ashworth Scale. Each section is scored from 0 to 4. A high score indicates hih spasticity.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cerebral palsy', 'balance', 'trunk'], 'conditions': ['Cerebral Palsy (CP)', 'Balance', 'Kinesiology Taping', 'Spasticity']}, 'descriptionModule': {'briefSummary': 'Title: Effects of Kinesiology Taping on Motor Function, Balance, and Spasticity in Children with Hemiplegic and Diplegic Cerebral Palsy: A Four-Week Study Study Type: Interventional (Clinical Trial) Study Design: Single-group, pre-post design Condition: Cerebral Palsy (Hemiplegic and Diplegic) Intervention: Kinesiology taping applied to trunk and extremity muscles over four weeks\n\nPrimary Outcome Measures:\n\nTrunk and joint range of motion (ROM) Manual muscle testing (MMT) of the trunk Spasticity assessment using the Modified Ashworth Scale (MAS)\n\nSecondary Outcome Measures:\n\nGross Motor Function Classification System (GMFCS) Functional Independence Measure for children (WeeFIM) Paediatric Berg Balance Scale (PBS) Sitting Assessment Scale (SAS) Study Duration: 4 weeks Sample Size: 30 children (aged X-Y years) with hemiplegic or diplegic cerebral palsy Pre- and post-intervention assessments were conducted. The study evaluates the short-term effects of kinesiology taping on motor function, spasticity, balance, and trunk control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children diagnosed with diparetic or hemiparetic cerebral palsy by a specialist physician;\n* Regular participation in physiotherapy sessions\n* Gross Motor Function Classification System (GMFCS) level 1, 2, or 3; Age between 2 and 18 years\n\nExclusion Criteria:\n\n* Children who have not attended physiotherapy sessions in the past six months,\n* Use of a trunk brace,\n* GMFCS level 4 or 5,\n* History of allergic reaction to kinesiology tape,\n* History of surgery within the past three months'}, 'identificationModule': {'nctId': 'NCT07188961', 'briefTitle': 'The Effect of Kinesiologic Taping on Trunk Control and Balance in Children With Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Rumeli University'}, 'officialTitle': 'The Effect of Kinesiologic Taping on Trunk Control and Balance in Children With Cerebral Palsy', 'orgStudyIdInfo': {'id': 'E-53938333-050-45047'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gruop 1', 'description': 'Kinesiologic taping was performed a total of four times, once a week.', 'interventionNames': ['Other: kinesiologic taping']}], 'interventions': [{'name': 'kinesiologic taping', 'type': 'OTHER', 'description': 'This intervention is distinguished from other studies by its combined assessment of trunk and extremity kinesiology taping in children with both hemiplegic and diplegic cerebral palsy over a four-week period.', 'armGroupLabels': ['Gruop 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Ozden Baskan', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Rumeli University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Ozden Baskan', 'investigatorAffiliation': 'Istanbul Rumeli University'}}}}