Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-31 @ 10:17 AM
Study NCT ID:
NCT01662960
Status:
COMPLETED
Last Update Posted:
2020-06-30
First Post:
2012-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010291', 'term': 'Paresis'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central 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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'stevenandrewjax@gmail.com', 'phone': '215-870-0196', 'title': 'Dr. Steven Jax', 'organization': 'Albert Einstein Healthcare Network'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From Baseline screening until 3-month post-treatment follow-up.', 'eventGroups': [{'id': 'EG000', 'title': 'Mirror Therapy: High Functioning', 'description': '4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.\n\nHigh functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Mirror Therapy: Low Functioning', 'description': '4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.\n\nLow functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Divider Therapy: High Functioning', 'description': '4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.\n\nHigh functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Divider Therapy: Low Functioning', 'description': '4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.\n\nLow functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Upper Extremity Fugl-Meyer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Mirror Therapy: High Functioning', 'description': '4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.\n\nHigh functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.'}, {'id': 'OG001', 'title': 'Mirror Therapy: Low Functioning', 'description': '4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.\n\nLow functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.'}, {'id': 'OG002', 'title': 'Divider Therapy: High Functioning', 'description': '4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.\n\nHigh functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.'}, {'id': 'OG003', 'title': 'Divider Therapy: Low Functioning', 'description': '4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.\n\nLow functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.'}], 'classes': [{'categories': [{'measurements': [{'value': '43.8', 'spread': '9.4', 'groupId': 'OG000'}, {'value': '21.4', 'spread': '5.7', 'groupId': 'OG001'}, {'value': '42.8', 'spread': '8.7', 'groupId': 'OG002'}, {'value': '21.5', 'spread': '6.3', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '.443', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '2.2', 'pValueComment': 'ANCOVA analysis with post-treatment score as the dependent variable, therapy type (Mirror therapy or Divider Therapy) as the independent variable, and pre-treatment score as the covariate. P-value reported is for the main effect of therapy type.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Test for the superiority of Mirror therapy over Divider therapy.'}], 'paramType': 'MEAN', 'timeFrame': 'Immediately after 1 month of treatment', 'description': 'This test measures impairment-level ability to move the arm and hand. Scores range from 0 to 66, with higher scores indicating greater ability to move the arm and hand.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started the treatment were included. Data for any participants who failed to complete the treatment were imputed.'}, {'type': 'PRIMARY', 'title': 'Action Research Arm Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Mirror Therapy: High Functioning', 'description': '4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.\n\nHigh functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.'}, {'id': 'OG001', 'title': 'Mirror Therapy: Low Functioning', 'description': '4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.\n\nLow functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.'}, {'id': 'OG002', 'title': 'Divider Therapy: High Functioning', 'description': '4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.\n\nHigh functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.'}, {'id': 'OG003', 'title': 'Divider Therapy: Low Functioning', 'description': '4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.\n\nLow functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.9', 'spread': '11.8', 'groupId': 'OG000'}, {'value': '7.1', 'spread': '5.0', 'groupId': 'OG001'}, {'value': '39.1', 'spread': '13.6', 'groupId': 'OG002'}, {'value': '7.7', 'spread': '5.6', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '.80', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.4', 'pValueComment': 'ANCOVA analysis with post-treatment score as the dependent variable, therapy type (Mirror therapy or Divider Therapy) as the independent variable, and pre-treatment score as the covariate. P-value reported is for the main effect of therapy type.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Test for the superiority of Mirror therapy over Divider therapy.'}], 'paramType': 'MEAN', 'timeFrame': '1 month', 'description': 'The test measures the ability to complete simulated everyday tasks with the arm. Scores range from 0 to 54, with higher scores indicating better performance.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started the treatment were included. Data for any participants who failed to complete the treatment were imputed.'}, {'type': 'PRIMARY', 'title': 'Rivermead Assessment of Somatosensory Performance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Mirror Therapy: High Functioning', 'description': '4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.\n\nHigh functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.'}, {'id': 'OG001', 'title': 'Mirror Therapy: Low Functioning', 'description': '4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.\n\nLow functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.'}, {'id': 'OG002', 'title': 'Divider Therapy: High Functioning', 'description': '4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.\n\nHigh functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.'}, {'id': 'OG003', 'title': 'Divider Therapy: Low Functioning', 'description': '4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.\n\nLow functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.76', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '0.52', 'spread': '0.19', 'groupId': 'OG001'}, {'value': '0.79', 'spread': '0.18', 'groupId': 'OG002'}, {'value': '0.60', 'spread': '0.20', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '.93', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-.002', 'pValueComment': 'ANCOVA analysis with post-treatment score as the dependent variable, therapy type (Mirror therapy or Divider Therapy) as the independent variable, and pre-treatment score as the covariate. P-value reported is for the main effect of therapy type.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Test for the superiority of Mirror therapy over Divider therapy.'}], 'paramType': 'MEAN', 'timeFrame': '1 month', 'description': 'This test measures the integrity of sensory perception of the arm. The score is the proportion of items answered correctly, and ranges from 0 to 1 with higher scores indicating better performance.', 'unitOfMeasure': 'Proportion of items correct.', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started the treatment were included. Data for any participants who failed to complete the treatment were imputed.'}, {'type': 'PRIMARY', 'title': 'Virtual-reality Assessment of Navigation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Mirror Therapy: High Functioning', 'description': '4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.\n\nHigh functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.'}, {'id': 'OG001', 'title': 'Mirror Therapy: Low Functioning', 'description': '4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.\n\nLow functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.'}, {'id': 'OG002', 'title': 'Divider Therapy: High Functioning', 'description': '4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.\n\nHigh functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.'}, {'id': 'OG003', 'title': 'Divider Therapy: Low Functioning', 'description': '4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.\n\nLow functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.'}], 'timeFrame': '1 month', 'description': 'This test measures the ability to detect lateralized attention problems in a simulated navigation test. Evidence for lateralized attentional problems was defined as a 20% difference in item detection between the left and right side.', 'reportingStatus': 'POSTED', 'populationDescription': 'No participants were administered the test in the post-treatment phase because no participant exhibited a baseline 20% difference in item detection between the left and right side.'}, {'type': 'SECONDARY', 'title': 'Stroke Impact Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Mirror Therapy: High Functioning', 'description': '4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.\n\nHigh functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.'}, {'id': 'OG001', 'title': 'Mirror Therapy: Low Functioning', 'description': '4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.\n\nLow functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.'}, {'id': 'OG002', 'title': 'Divider Therapy: High Functioning', 'description': '4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.\n\nHigh functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.'}, {'id': 'OG003', 'title': 'Divider Therapy: Low Functioning', 'description': '4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.\n\nLow functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.'}], 'classes': [{'categories': [{'measurements': [{'value': '221.0', 'spread': '32.5', 'groupId': 'OG000'}, {'value': '231.6', 'spread': '43.7', 'groupId': 'OG001'}, {'value': '237.8', 'spread': '25.7', 'groupId': 'OG002'}, {'value': '217.0', 'spread': '26.7', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '.28', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '10.7', 'pValueComment': 'ANCOVA analysis with post-treatment score as the dependent variable, therapy type (Mirror therapy or Divider Therapy) as the independent variable, and pre-treatment score as the covariate. P-value reported is for the main effect of therapy type.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Test for the superiority of Mirror therapy over Divider therapy.'}], 'paramType': 'MEAN', 'timeFrame': '1 month', 'description': 'This test measures the self-reported ability to complete everyday tasks with the arm. Total scores for all items are reported. The scale ranged from 0 to 300, with higher scores indicating higher self-reported ability.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started the treatment were included. Data for any participants who failed to complete the treatment were imputed.'}, {'type': 'SECONDARY', 'title': 'Wolf Motor Function Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Mirror Therapy: High Functioning', 'description': '4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.\n\nHigh functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.'}, {'id': 'OG001', 'title': 'Mirror Therapy: Low Functioning', 'description': '4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.\n\nLow functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.'}, {'id': 'OG002', 'title': 'Divider Therapy: High Functioning', 'description': '4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.\n\nHigh functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.'}, {'id': 'OG003', 'title': 'Divider Therapy: Low Functioning', 'description': '4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.\n\nLow functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.0', 'spread': '10.0', 'groupId': 'OG000'}, {'value': '22.3', 'spread': '6.0', 'groupId': 'OG001'}, {'value': '50.4', 'spread': '13.8', 'groupId': 'OG002'}, {'value': '24.7', 'spread': '6.7', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '.86', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-.36', 'pValueComment': 'ANCOVA analysis with post-treatment score as the dependent variable, therapy type (Mirror therapy or Divider Therapy) as the independent variable, and pre-treatment score as the covariate. P-value reported is for the main effect of therapy type.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Test for the superiority of Mirror therapy over Divider therapy.'}], 'paramType': 'MEAN', 'timeFrame': '1 months', 'description': 'The test measures the ability to completed simulated everyday tasks with the arm. The scale ranged from 0 to 75, with higher scores indicating better performance.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who started the treatment were included. Data for any participants who failed to complete the treatment were imputed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mirror Therapy: High Functioning', 'description': '4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.\n\nHigh functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.'}, {'id': 'FG001', 'title': 'Mirror Therapy: Low Functioning', 'description': '4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.\n\nLow functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.'}, {'id': 'FG002', 'title': 'Divider Therapy: High Functioning', 'description': '4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.\n\nHigh functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.'}, {'id': 'FG003', 'title': 'Divider Therapy: Low Functioning', 'description': '4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.\n\nLow functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.'}], 'periods': [{'title': 'End of 4 Week Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': '3 Month Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '72', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Mirror Therapy: High Functioning', 'description': '4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.\n\nHigh functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.'}, {'id': 'BG001', 'title': 'Mirror Therapy: Low Functioning', 'description': '4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.\n\nLow functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.'}, {'id': 'BG002', 'title': 'Divider Therapy: High Functioning', 'description': '4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.\n\nHigh functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 30-50.'}, {'id': 'BG003', 'title': 'Divider Therapy: Low Functioning', 'description': '4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.\n\nLow functioning was defined as pre-treatment upper extremity Fugl-Meyer score of 10-29.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.7', 'spread': '12.3', 'groupId': 'BG000'}, {'value': '53.7', 'spread': '14.9', 'groupId': 'BG001'}, {'value': '55.9', 'spread': '9.7', 'groupId': 'BG002'}, {'value': '57.5', 'spread': '12.7', 'groupId': 'BG003'}, {'value': '57.3', 'spread': '13.0', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '47', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '69', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Upper Extremity Fugl-Meyer', 'classes': [{'categories': [{'measurements': [{'value': '39.1', 'spread': '6.1', 'groupId': 'BG000'}, {'value': '17.5', 'spread': '4.2', 'groupId': 'BG001'}, {'value': '39.9', 'spread': '7.8', 'groupId': 'BG002'}, {'value': '18.8', 'spread': '6.1', 'groupId': 'BG003'}, {'value': '28.1', 'spread': '12.1', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'This test measures impairment-level ability to move the arm and hand. Scores range from 0 to 66, with higher scores indicating greater ability to move the arm and hand.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Action Research Arm Test', 'classes': [{'categories': [{'measurements': [{'value': '36.1', 'spread': '9.9', 'groupId': 'BG000'}, {'value': '5.8', 'spread': '4.4', 'groupId': 'BG001'}, {'value': '36.3', 'spread': '13.3', 'groupId': 'BG002'}, {'value': '6.7', 'spread': '4.4', 'groupId': 'BG003'}, {'value': '20.3', 'spread': '17.1', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'The test measures the ability to complete simulated everyday tasks with the arm. Scores range from 0 to 54, with higher scores indicating better performance.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Rivermead Assessment of Somatosensory Performance', 'classes': [{'categories': [{'measurements': [{'value': '0.72', 'spread': '0.17', 'groupId': 'BG000'}, {'value': '0.53', 'spread': '0.19', 'groupId': 'BG001'}, {'value': '0.79', 'spread': '0.20', 'groupId': 'BG002'}, {'value': '0.56', 'spread': '0.21', 'groupId': 'BG003'}, {'value': '0.63', 'spread': '0.21', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'This test measures the integrity of sensory perception of the arm. The score is the proportion of items answered correctly, and ranges from 0 to 1 with higher scores indicating better performance.', 'unitOfMeasure': 'Proportion of items correct', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Stroke Impact Scale', 'classes': [{'categories': [{'measurements': [{'value': '215.9', 'spread': '26.4', 'groupId': 'BG000'}, {'value': '219.9', 'spread': '35.0', 'groupId': 'BG001'}, {'value': '226.3', 'spread': '15.3', 'groupId': 'BG002'}, {'value': '215.7', 'spread': '28.7', 'groupId': 'BG003'}, {'value': '218.4', 'spread': '30.2', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'This test measures the self-reported ability to complete everyday tasks with the arm. Total scores for all items are reported. The scale ranged from 0 to 300, with higher scores indicating higher self-reported ability.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Wolf Motor Function Test', 'classes': [{'categories': [{'measurements': [{'value': '48.8', 'spread': '9.5', 'groupId': 'BG000'}, {'value': '22.7', 'spread': '5.7', 'groupId': 'BG001'}, {'value': '50.8', 'spread': '14.4', 'groupId': 'BG002'}, {'value': '25.1', 'spread': '7.2', 'groupId': 'BG003'}, {'value': '35.8', 'spread': '15.5', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'The test measures the ability to completed simulated everyday tasks with the arm. The scale ranged from 0 to 75, with higher scores indicating better performance.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Virtual-reality Assessment of Navigation', 'classes': [{'categories': [{'measurements': [{'value': '.047', 'spread': '.051', 'groupId': 'BG000'}, {'value': '.056', 'spread': '.059', 'groupId': 'BG001'}, {'value': '.022', 'spread': '.036', 'groupId': 'BG002'}, {'value': '.063', 'spread': '.086', 'groupId': 'BG003'}, {'value': '.050', 'spread': '.062', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'This test measures the ability to detect lateralized attention problems in a simulated navigation test. Evidence for lateralized attentional problems was defined as a 20% difference in item detection between the left and right side.', 'unitOfMeasure': 'proportion difference', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-10-17', 'size': 701142, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-01-18T16:18', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-19', 'studyFirstSubmitDate': '2012-08-08', 'resultsFirstSubmitDate': '2019-02-12', 'studyFirstSubmitQcDate': '2012-08-09', 'lastUpdatePostDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-02-12', 'studyFirstPostDateStruct': {'date': '2012-08-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Upper Extremity Fugl-Meyer', 'timeFrame': 'Immediately after 1 month of treatment', 'description': 'This test measures impairment-level ability to move the arm and hand. Scores range from 0 to 66, with higher scores indicating greater ability to move the arm and hand.'}, {'measure': 'Action Research Arm Test', 'timeFrame': '1 month', 'description': 'The test measures the ability to complete simulated everyday tasks with the arm. Scores range from 0 to 54, with higher scores indicating better performance.'}, {'measure': 'Rivermead Assessment of Somatosensory Performance', 'timeFrame': '1 month', 'description': 'This test measures the integrity of sensory perception of the arm. The score is the proportion of items answered correctly, and ranges from 0 to 1 with higher scores indicating better performance.'}, {'measure': 'Virtual-reality Assessment of Navigation', 'timeFrame': '1 month', 'description': 'This test measures the ability to detect lateralized attention problems in a simulated navigation test. Evidence for lateralized attentional problems was defined as a 20% difference in item detection between the left and right side.'}], 'secondaryOutcomes': [{'measure': 'Stroke Impact Scale', 'timeFrame': '1 month', 'description': 'This test measures the self-reported ability to complete everyday tasks with the arm. Total scores for all items are reported. The scale ranged from 0 to 300, with higher scores indicating higher self-reported ability.'}, {'measure': 'Wolf Motor Function Test', 'timeFrame': '1 months', 'description': 'The test measures the ability to completed simulated everyday tasks with the arm. The scale ranged from 0 to 75, with higher scores indicating better performance.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stroke', 'hemiparesis', 'arm movement', 'sensory functioning'], 'conditions': ['Hemiparesis', 'Stroke']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine whether an existing treatment for problems that participants have with making movements after a stroke can be performed at home.', 'detailedDescription': 'This study will compare two forms of home-based treatment for post-stroke problems making movements with the arms and hands. After initial pre-treatment assessments, participants will complete 4 weeks of treatment, with assessments after each week of treatment and 3 months after the completion of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 6 months or more post-stroke\n* upper extremity Fugl-Meyer score between 10 and 50\n* no longer participating in upper-extremity physical or occupational therapy\n* sufficient comprehension ability to understand instructions\n\nExclusion Criteria:\n\n* previous head trauma, psychiatric illness or chronic exposure to medications that might be expected to have lasting consequences for the central nervous system (e.g., haloperidol, dopaminergics)\n* dementia'}, 'identificationModule': {'nctId': 'NCT01662960', 'briefTitle': 'Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Albert Einstein Healthcare Network'}, 'officialTitle': 'Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke', 'orgStudyIdInfo': {'id': 'HN 4404'}, 'secondaryIdInfos': [{'id': 'NIH R01 HD068565', 'type': 'OTHER', 'domain': 'Einstein Healthcare Network'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mirror therapy', 'description': '4 weeks of home-based mirror therapy. Participants practiced making movements with mirrored visual feedback of the low-functioning arm.', 'interventionNames': ['Behavioral: Mirror therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Divider therapy', 'description': '4 weeks of home-based divider therapy (control therapy to mirror therapy; mirror replaced by a divider). Participants practiced making movements with no visual feedback of the low-functioning arm.', 'interventionNames': ['Behavioral: Divider therapy']}], 'interventions': [{'name': 'Mirror therapy', 'type': 'BEHAVIORAL', 'description': 'A home-based therapy involving mirrored visual feedback', 'armGroupLabels': ['Mirror therapy']}, {'name': 'Divider therapy', 'type': 'BEHAVIORAL', 'description': 'A home-based therapy involving removed visual feedback.', 'armGroupLabels': ['Divider therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19027', 'city': 'Elkins Park', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Einstein Medical Center Elkins Park', 'geoPoint': {'lat': 40.07706, 'lon': -75.12684}}], 'overallOfficials': [{'name': 'Steven Jax, Ph. D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Albert Einstein Healthcare Network'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Albert Einstein Healthcare Network', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Institute Scientist', 'investigatorFullName': 'Steve Jax', 'investigatorAffiliation': 'Albert Einstein Healthcare Network'}}}}