Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2025-12-27 @ 11:19 AM
Study NCT ID:
NCT04328168
Status:
COMPLETED
Last Update Posted:
2020-03-31
First Post:
2020-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparision Of The Effectiveness Of Physiotherapy Methods
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': 'D056888', 'term': 'Patient Positioning'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participant'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A total of 28 patients who were followed-up in our clinic and received botulinum toxin injection of lower extremities in the last month were randomized to two groups in the study. Group 1 received conventional physiotherapy and Group 2 received robot-assisted gait training.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2017-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-28', 'studyFirstSubmitDate': '2020-03-21', 'studyFirstSubmitQcDate': '2020-03-28', 'lastUpdatePostDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Gross Motor Function Classification System (GMFCS)', 'timeFrame': '3 weeks', 'description': 'The Gross Motor Function Classification System or GMFCS is a 5 level clinical classification system that describes the gross motor function of people with cerebral palsy on the basis of self-initiated movement abilities.'}, {'measure': 'The Edinburgh Visual Gait Scale (EVGS)', 'timeFrame': '3 weeks', 'description': 'The Edinburgh visual gait score is an evaluative tool that uses software and video cameras to provide 3D video gait analysis as well as onscreen drawing and measurement tools to evaluate each portion of gait. The software will then generate a EVGS report, with illustrative images from the video if desired, in PDF format.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Botulinum-toxin, cerebral-palsy, robot-assisted therapy'], 'conditions': ['Cerebral Palsy']}, 'descriptionModule': {'briefSummary': 'A total of 28 patients who were followed-up in our clinic and received botulinum toxin injection of lower extremities in the last month were randomized to two groups in the study. Group 1 received conventional physiotherapy and Group 2 received robot-assisted gait training. The treatment period was 30 min/day, five sessions in a week, 15 sessions in total, for both groups. The study population was evaluated using range of joint motion evaluation chart, the Modified Ashworth Scale, The Gross Motor Function Classification System, The Berg Balance Scale, the functional independence measure for children, and the Edinburgh Visual Gait Score', 'detailedDescription': 'A total of 28 patients who were followed-up in our clinic and received botulinum toxin injection of lower extremities in the last month were randomized to two groups in the study. Group 1 received conventional physiotherapy and Group 2 received robot-assisted gait training. The treatment period was 30 min/day, five sessions in a week, 15 sessions in total, for both groups. The study population was evaluated using range of joint motion evaluation chart, the Modified Ashworth Scale, The Gross Motor Function Classification System, The Berg Balance Scale, the functional independence measure for children, and the Edinburgh Visual Gait Score.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 4\\>, \\<16 with CP diagnosis\n* Walking diffculties due to the spasticity of lower extremities,\n* Level I-IV on the Gross Motor Function Classification System.\n\nExclusion Criteria:\n\n* MAS Level IV spasticity, contractures, or rigidity in the lower extremities,\n* A limb length inequality of \\>2 cm,\n* Hypotonic CP,\n* Having drug-related refractory epilepsy,\n* Undergoing intrathecal baclofen pump surgery,\n* Surgical interventions in the lower extremities in the last year,\n* Scoliosis angle of \\>30°,\n* Complicated osteoporosis (nontraumatic fracture...),\n* Cardiovascular instability,\n* GMFCS Level V,\n* Metabolic disorder, genetic disease, neurodegenerative and neuromuscular diseases.'}, 'identificationModule': {'nctId': 'NCT04328168', 'briefTitle': 'Comparision Of The Effectiveness Of Physiotherapy Methods', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Kayseri Education and Research Hospital'}, 'officialTitle': 'Comparision Of The Effectiveness Of Conventional Physiotherapy After Botulinum Toxin Injection In Children With Cerebral Palsy', 'orgStudyIdInfo': {'id': '2016/442'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group1', 'description': 'Conventional Physiotherapy', 'interventionNames': ['Procedure: ROM exercises, stretching, positioning, gait training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group2', 'description': 'robot-assisted gait training', 'interventionNames': ['Procedure: by two physiotherapist under the supervision of a doctor']}], 'interventions': [{'name': 'ROM exercises, stretching, positioning, gait training', 'type': 'PROCEDURE', 'armGroupLabels': ['Group1']}, {'name': 'by two physiotherapist under the supervision of a doctor', 'type': 'PROCEDURE', 'armGroupLabels': ['Group2']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'individual participant data (IPD) is not be available to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kayseri Education and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Kayseri Education and Research State Hospital', 'investigatorFullName': 'Dr. Ayşe Güç', 'investigatorAffiliation': 'Kayseri Education and Research Hospital'}}}}