Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2026-01-13 @ 5:22 PM
Study NCT ID:
NCT01668420
Status:
COMPLETED
Last Update Posted:
2012-11-09
First Post:
2012-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Thermal Stimulation for Lower Extremity Movement and Function in Patients With Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-07', 'studyFirstSubmitDate': '2012-08-12', 'studyFirstSubmitQcDate': '2012-08-14', 'lastUpdatePostDateStruct': {'date': '2012-11-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change score from baseline to post-treatment and baseline to 1M follow-up in the lower-limb subscale of the Stroke Rehabilitation Assessment of Movement(LE-STREAM)', 'timeFrame': 'pre, post, 1M follow-up', 'description': 'The lower-limb subscale of the Stroke Rehabilitation Assessment of Movement (LE-STREAM) was assessed at the time before the first intervention (pre-assessment), the time after the 24th TS (post-assessment). The whole intervention was finished within 10 weeks. The third assessment was at 1M follow-up.'}, {'measure': 'The change score from baseline to post-treatment and baseline to 1M follow-up in the mobility subscale of the Stroke Rehabilitation Assessment of Movement STREAM (Mob-STREAM)', 'timeFrame': 'pre, post, 1M follow-up', 'description': 'The mobility subscale of the Stroke Rehabilitation Assessment of Movement STREAM (Mob-STREAM) was assessed at the time before the first intervention (pre-assessment), the time after the 24th TS (post-assessment). The whole intervention was finished within 10 weeks. The third assessment was at 1M follow-up.'}, {'measure': 'The change score from baseline to post-treatment and baseline to 1M follow-up in the Functional Ambulation Category (FAC)', 'timeFrame': 'pre, post, 1M follow-up', 'description': 'Functional Ambulation Category (FAC) was assessed at the time before the first intervention (pre-assessment), the time after the 24th TS (post-assessment). The whole intervention was finished within 10 weeks. The third assessment was at 1M follow-up.'}, {'measure': 'The change score from baseline to post-treatment and baseline to 1M follow-up in the Barthel Index', 'timeFrame': 'pre, post, 1M follow-up', 'description': 'Barthel Index (BI) was assessed at the time before the first intervention (pre-assessment), the time after the 24th TS (post-assessment). The whole intervention was finished within 10 weeks. The third assessment was at 1M follow-up.'}], 'secondaryOutcomes': [{'measure': 'The change score from baseline to post-treatment and baseline to 1M follow-up in the Postural Assessment Scale for Stroke Patients (PASS)', 'timeFrame': 'pre, post, 1M follow-up', 'description': 'Postural Assessment Scale for Stroke Patients (PASS) was assessed at the time before the first intervention (pre-assessment), the time after the 24th TS (post-assessment). The whole intervention was finished within 10 weeks. The third assessment was at 1M follow-up.'}, {'measure': 'The change score from baseline to post-treatment and baseline to 1M follow-up in the Modified Ashworth Scale', 'timeFrame': 'pre, post, 1M follow-up', 'description': 'Modified Ashworth Scale (MAS) was assessed at the time before the first intervention (pre-assessment), the time after the 24th TS (post-assessment). The whole intervention was finished within 10 weeks. The third assessment was at 1M follow-up.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['thermal stimulation', 'lower extremity', 'temperature', 'efficacy'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'The thermal stimulation have been proven effective in upper extremity of stroke patients. Therefore, this study explored the efficacy of thermal stimulation in lower extremity of stroke patients.', 'detailedDescription': 'There are two groups of stroke patients (onset \\> 3 months) in this study. The independent factor is temperature of the alternated heat and cold applying.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'The inclusive criteria:\n\n* first-ever stroke\n* stroke onset \\> 3 months and \\< 3 years before the study enrollment\n* unilateral hemiplegia\n* ability to sit on a chair \\> 30 minutes independently\n* able to follow verbal instructions\n* age between 18 y/o and 80 y/o\n* be willing to participate in this study and gave their informed consent\n\nThe exclusive criteria:\n\n* skin disease, skin injuries, burns, or fresh scars over the TS application area\n* contraindication of ice or heat application\n* speech disorder or global aphasia\n* musculoskeletal or cardiac disorders that could potentially interfere\n* diabetic history or sensory impairment attributable to neuropathy.'}, 'identificationModule': {'nctId': 'NCT01668420', 'briefTitle': 'Effect of Thermal Stimulation for Lower Extremity Movement and Function in Patients With Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}, 'officialTitle': 'Effect of Thermal Stimulation for Lower Extremity Movement and Function in Patients With Stroke', 'orgStudyIdInfo': {'id': 'KMUH-IRB-980332'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'noxious thermal stimulation', 'description': 'Heat-pain:46-47°C and Cold-pain:2-3°C alternately (intervention) 3 times /week and total 24 TS while conventional rehabilitation program was given', 'interventionNames': ['Other: thermal stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'thermal stimulation (innocuous)', 'description': 'Heat:40-41°C and Cold:23-24°C alternately (intervention) 3 times /week and total 24 TS while conventional rehabilitation program was given', 'interventionNames': ['Other: thermal stimulation']}], 'interventions': [{'name': 'thermal stimulation', 'type': 'OTHER', 'otherNames': ['Thermal stimulation (FIRSTEK, Model-B401L,local company).'], 'description': 'hot and cold/warm and cool pads applying.', 'armGroupLabels': ['noxious thermal stimulation', 'thermal stimulation (innocuous)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '807', 'city': 'Kaohsiung City', 'state': 'Taiwan', 'country': 'Taiwan', 'facility': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}], 'overallOfficials': [{'name': 'Hsin-Wen Hsin, graduated', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hsin-Wen Hsu', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'physical therapist (graduated student)', 'investigatorFullName': 'Hsin-Wen Hsu', 'investigatorAffiliation': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}}}}