Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2026-02-25 @ 5:39 PM
Study NCT ID:
NCT02270294
Status:
COMPLETED
Last Update Posted:
2018-04-03
First Post:
2014-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Effects of Thai Traditional Massage on Cerebrovascular Reactivity in Ischemic Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000096262', 'term': 'Medicine, Thai Traditional'}], 'ancestors': [{'id': 'D008519', 'term': 'Medicine, Traditional'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2016-08-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-01', 'studyFirstSubmitDate': '2014-10-14', 'studyFirstSubmitQcDate': '2014-10-20', 'lastUpdatePostDateStruct': {'date': '2018-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in cerebrovascular reactivity', 'timeFrame': 'baseline, Post-test (immediately: 0 min after finish massage intervention, 60 min, 120 min, 24 Hrs.', 'description': '\\- Cerebrovascular reactivity or cerebral CO2 reactivity test will be assessed using the ultrasound equipment (CX50, Philips, USA). Blood flow velocity (BFV) of the middle cerebral artery (MCA) will be measured during normocapnic, hypocapnic, and hypercapnic states. Subjects will be asked to wear nose clips and breathe only through a mouthpiece. Baseline (3 minutes) recordings will be taken during spontaneous breathing of room air and then subjects underwent 1 minute of maximal voluntary hyperventilation with a duty cycle of 1 second. The MCA-BFV will be recorded during the last 20 seconds of hyperventilation. After that, subjects will be asked to breathe air containing a mixture of 5 % CO2 and 21 % O2 balanced with nitrogen spontaneously for 3 minutes and the MCA-BFV will be recorded during the last minute of hypercapnia.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in stress indicators', 'timeFrame': 'Baseline, Post-test (immediately: 0 min after finish massage intervention)', 'description': '\\- Serum cortisol will be measured with cortisol EIA kit (Enzo Life Science, Switzerland).'}, {'measure': 'Change from baseline in stress indicators', 'timeFrame': 'Baseline, Post-test (immediately: 0 min after finish massage intervention, 60 min, 120 min, 24 Hrs.', 'description': '\\- Heart rate variability (HRV) will be measured using the Heart rate monitoring (RS800CX, Polar Electro, Oy, Finland)'}, {'measure': 'Change from baseline in Peripheral arterial stiffness', 'timeFrame': 'Baseline, Post-test (immediately: 0 min after finish massage intervention, 60 min, 120 min, 24 Hrs.', 'description': '\\- Pulse wave velocity measurement will be assessed with MD6 bidirectional transcutaneous Doppler probe (Hokanson, Bellevue, WA, USA). All subjects will be monitored with an EKG and PWV measurements in the computer and used as timing markers for PWV identification.'}, {'measure': 'Change from baseline in blood chemistry', 'timeFrame': 'baseline, Post-test (immediately: 0 min after finish massage intervention)', 'description': '* Nitric oxide (NO) will be measured in plasma samples with Colorimetric nitric oxide assay kit (Biovision, USA).\n* Beta-endorphin will be measured in serum samples with the commercial assay kit (Beta-endorphin \\[bEP\\] BioAssay ELISA kit \\[Human\\], US Biological Life Science).\n* Malondialdehyde (MDA) will be determined using thiobarbituric acid reaction.'}]}, 'conditionsModule': {'keywords': ['Ischemic stroke', 'Thai traditional massage', 'Vascular function', 'Cerebral blood flow', 'Cerebrovascular reactivity'], 'conditions': ['Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that Acute Thai traditional massage will yield beneficial effects on cerebrovascular reactivity in ischemic stroke patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. A single ischemic stroke with Middle cerebral artery (MCA) stenosis\n2. Men or women age 50-80 years\n3. Physician's approvals to participate the study\n4. Stroke experienced at least 7 days of ischemic stroke onset and no more than 6 months before study enrollment\n5. The modified rankin scale level is 2 or 3\n\nExclusion Criteria:\n\n1. History of serious diseases\n\n * Musculoskeletal diseases (Chronic arthritis, Lower spondylosis/spondylolisthesis with radiculopathy, Spinal deformity, Cervical spondylosis, Rheumatoid arthritis)\n * Cardiovascular diseases (Poorly control hypertension, Heart disease class C and D)\n * Neurological disorders (Peripheral neuropathy, Parkinson)\n * Respiratory diseases (Chronic Obstructive Pulmonary Disease)\n * Brain disorders (Cardioembolic, Severe dementia, Alzheimer's disease)\n * Medical condition precluding taking Anticoagulant and Statin drug\n2. Temporal window were not found"}, 'identificationModule': {'nctId': 'NCT02270294', 'briefTitle': 'Acute Effects of Thai Traditional Massage on Cerebrovascular Reactivity in Ischemic Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'Chulalongkorn University'}, 'officialTitle': 'Acute Effects of Thai Traditional Massage on Cerebrovascular Reactivity in Ischemic Stroke Patients', 'orgStudyIdInfo': {'id': 'SPSC-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Thai traditional massage', 'interventionNames': ['Other: Thai traditional massage']}, {'type': 'SHAM_COMPARATOR', 'label': 'No massage', 'interventionNames': ['Other: No massage']}], 'interventions': [{'name': 'Thai traditional massage', 'type': 'OTHER', 'otherNames': ['Thai massage'], 'description': 'Thai traditional massage treatment based on original Thai traditional massage at Wat Po was use in this study. The participants will be assigned to receive one time of Thai traditional massage one time. Thai traditional massage techniques consists of petrissage, friction, and passive stretching on head, neck, shoulders, arms, back and legs for 60 minutes.', 'armGroupLabels': ['Thai traditional massage']}, {'name': 'No massage', 'type': 'OTHER', 'description': 'The participants will be asked to lie down in relaxant position on bed without sleep for 60 minutes.', 'armGroupLabels': ['No massage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10330', 'city': 'Pathumwan', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Faculty of Sports Science, Chulalongkorn University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chulalongkorn University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DSuksom', 'investigatorFullName': 'Assoc. Prof. Dr.Daroonwan Suksom', 'investigatorAffiliation': 'Chulalongkorn University'}}}}