Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-04-23 @ 9:36 PM
Study NCT ID:
NCT02358005
Status:
UNKNOWN
Last Update Posted:
2019-02-26
First Post:
2015-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimal Dose of Extracorporeal Shock Wave Therapy After Botulinum Toxin Type A Injection for Post-stroke Spasticity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-25', 'studyFirstSubmitDate': '2015-01-23', 'studyFirstSubmitQcDate': '2015-02-02', 'lastUpdatePostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Range of Motion (ROM) of elbow flexor', 'timeFrame': '5 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Post-Stroke Elbow Spasticity']}, 'descriptionModule': {'briefSummary': 'Recently, It is known that the efficacy of botulinum toxin type A (BTX-A) with extracorporeal shock wave therapy (ESWT) is greater than that of BTX-A with electrical stimulation in the management of post-stroke spasticity of the upper limb. However, it was not determined which dose of ESWT is optimal as a adjuvant therapy after BTX-A injection on the upper limb in patients with stroke. Therefore, the aim of this study is to evaluate the optimal dose of ESWT after botulinum toxin type A injection for post-stroke spasticity'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female\n* Age ≥20 years\n* inpatients\n* Elbow flexor spasticity in patients, confirmed to be mainly due to biceps brachii\n* Modified Ashworth scale (MAS) ≥2,\n* At least a 3-month period from stroke,\n* Written informed consent has been obtained\n\nExclusion Criteria:\n\n* Fixed contractures and/or deformities at the elbow,\n* Previous fractures of the paretic upper limb,\n* Peripheral nervous system disorders/myopathies,\n* Previous BTX-A treatment and/or ESWT,\n* Structural alterations in the soft tissue (e.g., fibrosis),\n* Known allergy or sensitivity to the study medication or its components\n* Presence of an unstable medical condition or uncontrolled systemic disease\n* Any medical condition that may put the patient at increased risk with exposure to botulinum toxin therapy. (ex. Myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interface with neuromuscular function.\n* Bleeding tendency and/or anticoagulation therapy\n* Presence of infection or skin disorder at injection sites\n* Females were are pregnant, nursing, or are planning a pregnancy during the study\n* Females of child-bearing potential (including pre-menstrual woman), not using a reliable means of contraception\n* Participant who should be withdrawn from the study in the opinion of the investigator for any reason'}, 'identificationModule': {'nctId': 'NCT02358005', 'briefTitle': 'Optimal Dose of Extracorporeal Shock Wave Therapy After Botulinum Toxin Type A Injection for Post-stroke Spasticity', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2014-0925'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '60mJ ESWT', 'description': 'ESWT (0.04 mJ/mm2, 1500 shock + sham stimulation 2500) / total dose per treatment : 60mJ', 'interventionNames': ['Procedure: Extracorporeal shock wave therapy 60mj']}, {'type': 'EXPERIMENTAL', 'label': '120mJ ESWT', 'description': 'ESWT (0.04 mJ/mm2, 4000 shock) / total dose per treatment : 160mJ', 'interventionNames': ['Procedure: Extracorporeal shock wave therapy 120mj']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'sham ESWT stimulation', 'description': 'ESWT (0 mJ/mm2, sham stimulation 4000) / total dose per treatment : 0mJ', 'interventionNames': ['Procedure: non extracorporeal shock wave therapy']}], 'interventions': [{'name': 'Extracorporeal shock wave therapy 60mj', 'type': 'PROCEDURE', 'armGroupLabels': ['60mJ ESWT']}, {'name': 'Extracorporeal shock wave therapy 120mj', 'type': 'PROCEDURE', 'armGroupLabels': ['120mJ ESWT']}, {'name': 'non extracorporeal shock wave therapy', 'type': 'PROCEDURE', 'armGroupLabels': ['sham ESWT stimulation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Yong Wook Kim, MD', 'role': 'CONTACT', 'email': 'YWKIM1@yuhs.ac', 'phone': '+82 2-2228-3716'}], 'facility': 'Yonsei University Healthcare System, Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Yong Wook Kim, MD', 'role': 'CONTACT', 'email': 'YWKIM1@yuhs.ac', 'phone': '+82 -2-2228-3716'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}