Ignite Creation Date:
2025-12-25 @ 1:01 AM
Ignite Modification Date:
2025-12-25 @ 11:15 PM
Study NCT ID:
NCT01658293
Status:
COMPLETED
Last Update Posted:
2022-01-26
First Post:
2012-08-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Thermal Stimulation for Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D010291', 'term': 'Paresis'}], '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': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2014-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-25', 'studyFirstSubmitDate': '2012-08-01', 'studyFirstSubmitQcDate': '2012-08-06', 'lastUpdatePostDateStruct': {'date': '2022-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fugl-Meyer Assessment Scale for stroke upper limb recovery', 'timeFrame': 'one year', 'description': 'The investigators will use the Fugl-Meyer Assessment Scale as the primary outcome measures in this study evaluating at baseline before TS and six weeks after TS, then at 3, 6 and 12 months for follow-up.'}, {'measure': 'motricity index', 'timeFrame': 'one year', 'description': 'The investigators will use the motricity index as the primary outcome measures in this study evaluating at baseline before TS and six weeks after TS, then at 3, 6 and 12 months for follow-up.'}], 'secondaryOutcomes': [{'measure': 'Semmes-Weinstein monofilaments for sensory functions', 'timeFrame': 'one year', 'description': 'The investigators selected the Semmes-Weinstein monofilaments for sensory functions as our secondary outcome measures evaluating at baseline before TS and six weeks after TS, then at 3, 6 and 12 months for follow-up.'}, {'measure': 'the modified motor assessment scale', 'timeFrame': 'one year', 'description': 'The investigators used the modified motor assessment scale as the primary outcome measures in this study evaluating at baseline before TS and six weeks after TS, then at 3, 6 and 12 months for follow-up.'}, {'measure': 'Barthel index', 'timeFrame': 'one year', 'description': 'The investigators used the Barthel index as the primary outcome measures in this study evaluating at baseline before TS and six weeks after TS, then at 3, 6 and 12 months for follow-up.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stroke', 'follow up', 'upper limb', 'rehabilitation'], 'conditions': ['Stroke', 'Upper Limb Paresis']}, 'referencesModule': {'references': [{'pmid': '38734047', 'type': 'DERIVED', 'citation': 'Chiu YT, Liang CC, Yu Cheng H, Lin CH, Chen JC. Alternating Hot-Cold Water Immersion Facilitates Motor Function Recovery in the Paretic Upper Limb After Stroke: A Pilot Randomized Controlled Trial. Arch Phys Med Rehabil. 2024 Sep;105(9):1642-1648. doi: 10.1016/j.apmr.2024.05.008. Epub 2024 May 10.'}]}, 'descriptionModule': {'briefSummary': 'Sensory and/or motor deficits in upper limb following stroke often have negative impacts on their daily living. Thermal stimulation with hot and cold pack alternatively incorporated into conventional rehabilitation has been reported and proved to be effective for upper limb functional recovery after stroke. However, whether hot- and cold-water stimulation alternatively based on thermal stimulation also has the effect still remains unknown. The aim of present study is to investigate the facilitated effect of hot and cold water stimulation alternatively on upper limb after stroke.', 'detailedDescription': "Stroke patients from department of rehabilitation in Tzu Chi general hospital will be recruited and randomized into two groups, one for experimental group and the other for control group. In addition to receiving routine standard rehabilitation for both groups, the experimental group will receive additional hot- and cold-water stimulation alternatively for five times one session, consecutive four sessions a set, one set for 30 minutes a day and five sets a week for six weeks. The control group will be given ergometer exercises with the similar duration as experimental group. Both groups will be evaluated at baseline before TS and every two weeks till six weeks after TS, then at 3, 6 and 12 months for follow-up. A variety of evaluations used in the present study include Semmes-Weinstein monofilaments for sensory functions; Brunnstrom's stage, Fugl-Meyer Assessment Scale and Motricity Index were used for upper limb motor control and strength; Box and block test for hand dexterity. The modified Motor Assessment Scale and Barthel Index are utilized for evaluating general motor functions and daily activity performance, respectively. The modified Ashworth scale is used for change of muscle tone of upper limb."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* a first-time ischemic or hemorrhagic stroke.\n* no severe diabetes or peripheral vascular disease causing sensory deficits.\n* no cognition problem and follow directions indicated by therapist during experiment.\n* motor deficit of the upper limb under (including) Brunnstrom stage IV, either in the arm or hand.\n\nExclusion Criteria:\n\n* a cardiac disease or orthopedic problem history,\n* medically unstable such as experienced unstable angina, uncontrolled hypertension according to the treating physician, psychological history before stroke.'}, 'identificationModule': {'nctId': 'NCT01658293', 'acronym': 'TSSP', 'briefTitle': 'Thermal Stimulation for Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'Buddhist Tzu Chi General Hospital'}, 'officialTitle': 'Facilitation of Sensory and Motor Recovery by Means of Heat and Cold-water Stimulation on the Paretic Upper Limb of After Stroke: One Year Follow up', 'orgStudyIdInfo': {'id': 'IRB100-25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'thermal stimulation', 'description': 'The experimental group receiving heat and cold-water stimulation, 30 minutes a session, five sessions a week for six weeks.', 'interventionNames': ['Behavioral: thermal stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'The control group receiving the similar intensity of ergometer exercise as the experimental group.', 'interventionNames': ['Behavioral: control group ergometer exercises']}], 'interventions': [{'name': 'thermal stimulation', 'type': 'BEHAVIORAL', 'description': 'The heat and cold-water will be added to the thermal group for 30-40minutes a session daily,five sessions a week for six weeks.', 'armGroupLabels': ['thermal stimulation']}, {'name': 'control group ergometer exercises', 'type': 'BEHAVIORAL', 'description': 'The control group will be given ergometer exercises with the similar duration as experimental group.', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '970', 'city': 'Hualien City', 'country': 'Taiwan', 'facility': 'Tzu Chi Buddhist General Hospital', 'geoPoint': {'lat': 23.97694, 'lon': 121.60444}}], 'overallOfficials': [{'name': 'Jia-Ching Chen, master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tzu Chi Buddhist General Hospital, Hualien, Taiwan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Buddhist Tzu Chi General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Rehabilitation Medicine', 'investigatorFullName': 'Jia-Ching Chen', 'investigatorAffiliation': 'Buddhist Tzu Chi General Hospital'}}}}