Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-30 @ 10:13 PM
Study NCT ID:
NCT05251532
Status:
COMPLETED
Last Update Posted:
2022-09-01
First Post:
2022-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Distortion Banding on Outcome Measures 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised Controlled Trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-08-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-27', 'studyFirstSubmitDate': '2022-01-31', 'studyFirstSubmitQcDate': '2022-02-13', 'lastUpdatePostDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TUG', 'timeFrame': 'Change from Baseline TUG at 3 days', 'description': 'Patients are asked to get up from a standard chair, walk 3 meters at a safe and comfortable pace, and return without stopping to sit back in the chair safely. The elapsed time is calculated. There is no score range in TUG.'}, {'measure': 'SLS', 'timeFrame': 'Change from Baseline SLS at 3 days', 'description': 'The one-leg standing test measures the time one is able to stand on one lower limb without support. There is no score range in SLS.'}, {'measure': 'Modified Ashworth Scale (MAS)', 'timeFrame': 'Change from Baseline MAS at 3 days', 'description': 'The Modified Ashworth Scale is a 6-point rating scale for gauging muscle resistance to passive movement. MAS is scored from 0 to 4, where lower scores represent normal muscle tone and higher scores represent spasticity.'}, {'measure': 'WGS', 'timeFrame': 'Change from Baseline WGS at 3 days', 'description': 'The scale allows for a multifactorial gait analysis, takes in to account 14 observable gait parameters divided into four sub-scales referring to particular phases of gait, i.e. stance phase, toe off, swing phase, andheel strike. WGS is scored from 13.35 to 42.0. Higher scores indicate higher impairment.'}, {'measure': 'CHQ', 'timeFrame': 'Change from Baseline CHQ at 3 days', 'description': 'The CHQ is a validated multidimensional instrument that measures the functional health and well-being of children and young people. CHQ is scored from 0 to 100. Higher scores indicate better health status.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cerebral palsy', 'Kinesio taping'], 'conditions': ['Cerebral Palsy, Spastic']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare the conventional rehabilitation program and the distortion taping applied with Kinesio Tex tape in addition to conventional rehabilitation in children with hemiplegic or monoplegic cerebral palsy with ankle varus deformity.', 'detailedDescription': "Conventional rehabilitation practices will be applied to the control group. In addition to Kinesio Tex tape distortion taping, conventional rehabilitation will be applied to the intervention group. It is aimed to evaluate the patients' balance, quality of life, performance test, spasticity level and gait quality."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children with cerebral palsy aged 4-12 years with unilateral involvement who are hemiplegic or monoplegic\n* Cases with Gross Motor Function Classification (GMFCS) level 1 or 2\n* Understanding simple commands and signing the consent form\n\nExclusion Criteria:\n\n* Presence of equinus deformity\n* Situations that may prevent assessments or communication\n* Lack of cooperation during work\n* Presence of surgery that may affect assessments, such as joint freezing\n* Presence of botulinum toxin administration in the last 6 months\n* Development of an allergic reaction on the skin to the tape'}, 'identificationModule': {'nctId': 'NCT05251532', 'briefTitle': 'The Efficacy of Distortion Banding on Outcome Measures in Children With Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Muğla Sıtkı Koçman University'}, 'officialTitle': 'The Efficacy of Distortion Taping on Balance, Performance, Gait, Spasticity and Quality of Life in Ankle Varus Deformity in Children With Cerebral Palsy', 'orgStudyIdInfo': {'id': 'CPKT2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Kinesio Taping Group (KTG)', 'description': 'Distortion taping with Kinesio Tex will be applied to the patients in addition to conventional rehabilitation through a pediatric physiotherapist.', 'interventionNames': ['Other: Kinesio Taping']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Rehabilitation Group (CRG)', 'description': 'Conventional rehabilitation program will be applied to the patients through a pediatric physiotherapist.', 'interventionNames': ['Other: Conventional Rehabilitation']}], 'interventions': [{'name': 'Kinesio Taping', 'type': 'OTHER', 'description': 'In addition to Kinesio Tex tape distortion taping, conventional rehabilitation is applied.', 'armGroupLabels': ['Kinesio Taping Group (KTG)']}, {'name': 'Conventional Rehabilitation', 'type': 'OTHER', 'description': 'Conventional rehabilitation practices are carried out', 'armGroupLabels': ['Conventional Rehabilitation Group (CRG)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48300', 'city': 'Muğla', 'state': 'Fethiye', 'country': 'Turkey (Türkiye)', 'facility': 'Fethiye Private Son Atılım Special Education and Rehabilitation Center', 'geoPoint': {'lat': 37.21807, 'lon': 28.3665}}], 'overallOfficials': [{'name': 'Ahmet İmerci, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Muğla Sıtkı Koçman University'}, {'name': 'İsmet Tümtürk, BSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ege University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Muğla Sıtkı Koçman University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Fatih Ozden', 'investigatorAffiliation': 'Muğla Sıtkı Koçman University'}}}}