Ignite Creation Date:
2025-12-25 @ 1:07 AM
Ignite Modification Date:
2026-01-01 @ 5:45 AM
Study NCT ID:
NCT04550793
Status:
UNKNOWN
Last Update Posted:
2020-09-16
First Post:
2020-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Shear Wave Ultrasound Elastography for Follow up After Anti-spastic Intervention Among Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D009128', 'term': 'Muscle Spasticity'}, {'id': 'D001906', 'term': 'Botulism'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular 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'}, {'id': 'D003015', 'term': 'Clostridium Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D020511', 'term': 'Neuromuscular Junction Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D020258', 'term': 'Neurotoxicity Syndromes'}, {'id': 'D005517', 'term': 'Foodborne Diseases'}, {'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001905', 'term': 'Botulinum Toxins'}], 'ancestors': [{'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '12 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-09', 'studyFirstSubmitDate': '2020-09-09', 'studyFirstSubmitQcDate': '2020-09-09', 'lastUpdatePostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Shear Wave Ultrasound Elastography', 'timeFrame': 'During each follow up visit within 12 weeks time frame', 'description': 'Shear wave ultrasound elastography measurement of spastic upper limb muscles, including biceps brachii and brachialis'}], 'secondaryOutcomes': [{'measure': "Barthel Index (Wade's version)", 'timeFrame': 'During each follow up visit within 12 weeks time frame', 'description': 'Barthel Index assessing activities of daily livings'}, {'measure': 'Revised Nottingham Extended Activities of Daily Livings Scale', 'timeFrame': 'During each follow up visit within 12 weeks time frame', 'description': 'Revised Nottingham Extended Scale assessing activities of daily livings'}, {'measure': 'Stroke Rehabilitation Assessment of Movement (STREAM), brief version', 'timeFrame': 'During each follow up visit within 12 weeks time frame', 'description': 'STREAM assessing movement condition'}, {'measure': 'Modified Ashworth Scale (MAS)', 'timeFrame': 'During each follow up visit within 12 weeks time frame', 'description': 'MAS scale for assessing spasticity'}, {'measure': 'Tone Assessment Scale (TAS)', 'timeFrame': 'During each follow up visit within 12 weeks time frame', 'description': 'TAS scale for assessing spasticity'}, {'measure': 'Global improvement scale', 'timeFrame': 'During each follow up visit within 12 weeks time frame', 'description': 'Global improvement scale for assessing symptoms related to stroke'}, {'measure': 'Self-report spasticity symptoms', 'timeFrame': 'During each follow up visit within 12 weeks time frame', 'description': 'Self-report spasticity symptoms for assessing spasticity'}, {'measure': 'EuroQol', 'timeFrame': 'During each follow up visit within 12 weeks time frame', 'description': 'EuroQol for evaluating quality of life'}, {'measure': 'Extended Activities of Daily Living', 'timeFrame': 'During each follow up visit within 12 weeks time frame', 'description': 'Extended Activities of Daily Living scale for evaluating activity of daily living'}, {'measure': 'Postural Assessment Scale for Stroke Patients (PASS), brief version', 'timeFrame': 'During each follow up visit within 12 weeks time frame', 'description': 'PASS for evaluating symptoms related to stroke'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke', 'Spasticity, Muscle', 'Botulism', 'Ultrasound', 'Activity of Daily Living']}, 'descriptionModule': {'briefSummary': 'Spasticity of stroke patient, a very common complication in clinical practice, affects performance of hand function and gait pattern. It also interferes with quality of life of patients severely. Currently first line clinical approach to spasticity consist of physical therapy and pharmacological management. However, there are still some refractory cases that needed local intervention such as Botox injection.\n\nSo far, we only can use subjective methods to measure muscle tension, such as modified Ashworth scale and Tone Assessment Scale. In our previous study, we found that ultrasound shear wave image could correlate with muscle stiffness caused by poststroke spasticity. With this new method, we aim to establish a more objective method in measuring abnormal poststroke muscle tension before and after treatments and further monitor therapeutic effect. We also include several assessment scales to evaluate the correlation between measured muscle spasm and activity of daily living.\n\nWe hypothesize that the rheological changes in muscles muscle spasm after Botox injection can be detected by ultrasound shear wave image. Therapeutic effect can also be seen in its effect on daily functions.\n\nIn this project, we will use shear wave imaging of ultrasound to investigate the elasticity (and hardness) of the biceps brachii and brachialis muscle in stroke patients with unilateral hemiplegia before and after Botox injection. The findings of this project will provide the objective evaluation of muscle spasticity and its correlation with functional status, which will provide new points of view toward treatment of spasticity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Stroke patient aged above 20 years old with unilateral involvement.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n\\[Intervention group\\]\n\n* Stroke patients with unilateral involvement\n* Patient's spasticity over affected upper extremities scored at least 1+ with Modified Ashworth Scale\n* Patient required botulinum toxin injection at affected upper limb muscle per primary care physician.\n\n\\[Control group\\]\n\n* Stroke patients with unilateral involvement\n* Patient's spasticity over affected upper extremities scored at least 1+ with Modified Ashworth Scale\n\nExclusion Criteria:\n\n* Patients ever diagnosed with cerebral diseases other than stroke, such as traumatic brain injury, encephalitis and brain tumor\n* Patients failed to cooperated due to cognition, consciousness or speech problem\n* Patients with illness that could affect muscle stiffness, such as spinal cord injury and Parkinson's disease\n* Patients with upper limb contracture\n* Patients receiving botulinum toxin injection or shock wave therapy over upper extremities during past three months"}, 'identificationModule': {'nctId': 'NCT04550793', 'briefTitle': 'Using Shear Wave Ultrasound Elastography for Follow up After Anti-spastic Intervention Among Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Using Shear Wave Ultrasound Elastography for Follow up After Anti-spastic Intervention Among Stroke Patients', 'orgStudyIdInfo': {'id': '202006138RINB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Intervention', 'description': 'The stroke patients who receive botulinum toxin injection at affected brachialis and/or biceps brachials.', 'interventionNames': ['Drug: Botulinum toxin injection']}, {'label': 'Control', 'description': 'The stroke patients who do not receive botulinum toxin injection at affected brachialis and/or biceps brachials in the past 3 months.'}], 'interventions': [{'name': 'Botulinum toxin injection', 'type': 'DRUG', 'description': 'Botulinum toxin injection at affected brachialis and/or biceps brachials.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Huey-Wen Liang, MD PHD', 'role': 'CONTACT', 'email': 'ntuhpmr.4124@gmail.com', 'phone': '886-2-23123456', 'phoneExt': '66697'}], 'overallOfficials': [{'name': 'Huey-Wen Liang, MD PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}