Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 12:27 AM
Study NCT ID:
NCT01655160
Status:
COMPLETED
Last Update Posted:
2015-06-08
First Post:
2012-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects and Mechanisms of Treatment Intensity of Mirror Therapy in Patients With Subacute 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000088762', 'term': 'Mirror Movement Therapy'}], 'ancestors': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-04', 'studyFirstSubmitDate': '2012-07-30', 'studyFirstSubmitQcDate': '2012-07-31', 'lastUpdatePostDateStruct': {'date': '2015-06-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fugl-Meyer Assessment (FMA)', 'timeFrame': 'Baseline, change from baseline in FMA at 2 weeks, and change from baseline in FMA at 4 weeks', 'description': 'The UE subscale of the FMA (max. score 66) uses a 3-point ordinal scale to assess motor impairment.'}, {'measure': 'Action Research Arm Test (ARAT)', 'timeFrame': 'Baseline, change of ARAT at 2 weeks, and change of ARAT at 4 weeks', 'description': 'ARAT will be used to assess the motor function of UE. A total of 19 items are to test the movement of grasp, grip, pinch, and gross motor, with a scale of 0-3 for each item (maximal of 57).'}, {'measure': 'Motor Activity Log (MAL)', 'timeFrame': 'Baseline, change of MAL at 2 weeks, and change of MAL at 4 weeks', 'description': 'The MAL is a semi-structured interview of patients to assess the amount of use (AOU) and quality of movement (QOM) of the affected upper extremity in 30 important daily activities using a 6-point ordinal scale. Higher scores indicate better performance.'}, {'measure': 'ABILHAND Questionnaire', 'timeFrame': 'Baseline, change of ABILHAND Questionnaire at 2 weeks, and change of ABILHAND Questionnaire at 4 weeks', 'description': 'ABILHAND questionnaire is an inventory of 56 manual activities that uses a 3-point ordinal scale to measure subjectively perceived difficulty in performing everyday bimanual activity.'}, {'measure': 'Adelaide Activities Profile (AAP)', 'timeFrame': 'Baseline, change of AAP at 2 weeks, and change of AAP at 4 weeks', 'description': 'AAP will be applied to indicate the level of participation in household and community activities. This profile includes 21 activities in the four areas: domestic chores, household maintenance, service to others, and social activities.'}], 'secondaryOutcomes': [{'measure': 'Functional magnetic resonance imaging (fMRI)', 'timeFrame': 'Baseline and change of fMRI at 4 weeks', 'description': 'uses the blood oxygenation level-dependent (BOLD) response to evaluate the brain reorganization after intervention.'}, {'measure': 'Physiological marker measures', 'timeFrame': 'Baseline and change from baseline in physiological marker measures at 4 weeks', 'description': 'measure inflammatory markers, oxidative stress markers, and erythrocyte deformability.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Stroke rehabilitation', 'Mirror therapy', 'Functional performance', 'Kinematic analysis', 'Functional magnetic resonance image', 'Motor recovery'], 'conditions': ['Cerebrovascular Accident']}, 'descriptionModule': {'briefSummary': 'The purpose of this study will evaluate the long-term benefits, optimal dose and mechanisms of mirror therapy and its effects on physiological markers.', 'detailedDescription': 'This trial is to examine whether (1) the immediate effects of treatment intensity in MT would occur on sensorimotor impairments and functional performance in patients with subacute stroke; (2) the long-term benefits of treatment intensity in MT on functionality can persist for six months after treatment finished; and (3) the MT could result in cortical/movement reorganization as well as the changes in physiological markers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* first episode of stroke in cortical regions\n* time since stroke less than 3 months\n* initial motor part of UE of FMA score ranging from 24 to 52\n* no serious cognitive impairment\n\nExclusion Criteria:\n\n* aphasia\n* visual impairments\n* major health problems or poor physical conditions\n* currently participation in any other'}, 'identificationModule': {'nctId': 'NCT01655160', 'briefTitle': 'Effects and Mechanisms of Treatment Intensity of Mirror Therapy in Patients With Subacute Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Effects and Mechanisms of Treatment Intensity of Mirror Therapy in Patients With Subacute Stroke: Outcomes in Brain and Movement Reorganization, Sensorimotor and Daily Functions, and Measures of Physiological Markers.', 'orgStudyIdInfo': {'id': '100-4548B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mirror therapy treatment', 'description': 'Three groups will be involved in this part of the whole project:MT with low-intensity group (MT-LI), MT with moderate-intensity group (MT-MI), MT with high-intensity group (MT-HI)', 'interventionNames': ['Behavioral: MT with low-intensity group (MT-LI)', 'Behavioral: MT with moderate-intensity group', 'Behavioral: Mirror therapy with high intensity group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control intervention group', 'description': 'The part of this project will involve 1 treatment groups:control intervention group (CI)', 'interventionNames': ['Behavioral: Control intervention group']}], 'interventions': [{'name': 'MT with low-intensity group (MT-LI)', 'type': 'BEHAVIORAL', 'otherNames': ['MT-LI'], 'description': 'The MT-LI group will receive a 30-minute MT per session followed by a 30-minute functional training.', 'armGroupLabels': ['mirror therapy treatment']}, {'name': 'MT with moderate-intensity group', 'type': 'BEHAVIORAL', 'otherNames': ['MT-MI'], 'description': 'The MT-MI group will receive a 60-minute MT per session followed by a 30-minute functional training.', 'armGroupLabels': ['mirror therapy treatment']}, {'name': 'Mirror therapy with high intensity group', 'type': 'BEHAVIORAL', 'otherNames': ['MT-HI'], 'description': 'The MT-HI group will receive a 90-minute MT per session followed by a 30-minute functional training', 'armGroupLabels': ['mirror therapy treatment']}, {'name': 'Control intervention group', 'type': 'BEHAVIORAL', 'otherNames': ['CI'], 'description': 'The CI group will carry out a 30-minute conventional stroke rehabilitation training per session followed by a 30-minute functional training.', 'armGroupLabels': ['control intervention group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kwei-shan', 'state': 'Toayuan County', 'country': 'Taiwan', 'facility': 'Chang Gung Memorial Hospital'}], 'overallOfficials': [{'name': 'Ching-yi Wu, ScD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chang Gung University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Science and Technology Council, Taiwan', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}