Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-02-20 @ 6:24 PM
Study NCT ID:
NCT02755805
Status:
COMPLETED
Last Update Posted:
2017-11-06
First Post:
2016-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
CO-OPerative Training for Stroke Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'skidmore@pitt.edu', 'phone': '(412) 383-6617', 'title': 'Elizabeth R. Skidmore, PhD, OTR/L, FAOTA', 'organization': 'University of Pittsburgh'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'CO-OP', 'description': 'Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.\n\nCO-OP', 'otherNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Attention Control', 'description': "The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.\n\nAttention Control", 'otherNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Difference in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CO-OP', 'description': 'Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.\n\nCO-OP'}, {'id': 'OG001', 'title': 'Attention Control', 'description': "The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.\n\nAttention Control"}], 'classes': [{'title': 'Baseline Scores', 'categories': [{'measurements': [{'value': '65.27', 'spread': '2.80', 'groupId': 'OG000'}, {'value': '62.60', 'spread': '4.28', 'groupId': 'OG001'}]}]}, {'title': 'Discharge Scores', 'categories': [{'measurements': [{'value': '86.80', 'spread': '3.27', 'groupId': 'OG000'}, {'value': '80.53', 'spread': '5.73', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '109.69', 'spread': '2.61', 'groupId': 'OG000'}, {'value': '91.23', 'spread': '7.48', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '113.31', 'spread': '2.48', 'groupId': 'OG000'}, {'value': '95.27', 'spread': '7.60', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'paramType': "Cohen's d effect size at month 6", 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.11', 'pValueComment': 'a priori threshold set at p\\<0.05', 'estimateComment': 'Effect size was calculated using mean change scores (baseline to month 6) and standard error of change (baseline to month 6) for each group.', 'groupDescription': 'All analyses were performed using the intent-to-treat principle so that comparisons were made according to the assigned intervention group regardless of study completion.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'F(3,74)=4.37\n\nP-values were calculated using mixed model analyses and controlled for stoke severity as a covariate.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, rehabilitation discharge, month 3, month 6', 'description': 'Difference between groups in mean scores (computed from Functional Independence Measure total scores) over time were examined with mixed effects models.\n\nThe Functional Independence Measure contains 18 items with a total score ranging from 18-126 is obtained (18=complete dependence/total assistance with basic self-care and mobility activities; 126=complete independence with basic self-care and mobility activities). Total scores were calculated at baseline, rehabilitation discharge, month 3, and month 6 for each participant, and mean total scores were calculated fro each group at each time point.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Difference in Executive Function- Inhibition, CWI (Color Word Interference Inhibition Scale)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CO-OP', 'description': 'Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.\n\nCO-OP'}, {'id': 'OG001', 'title': 'Attention Control', 'description': "The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.\n\nAttention Control"}], 'classes': [{'title': 'Baseline Scores', 'categories': [{'measurements': [{'value': '4.85', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '4.00', 'spread': '0.77', 'groupId': 'OG001'}]}]}, {'title': 'Month 3 Scores', 'categories': [{'measurements': [{'value': '8.73', 'spread': '3.00', 'groupId': 'OG000'}, {'value': '4.40', 'spread': '1.37', 'groupId': 'OG001'}]}]}, {'title': 'Month 6 Scores', 'categories': [{'measurements': [{'value': '8.20', 'spread': '1.13', 'groupId': 'OG000'}, {'value': '3.67', 'spread': '1.11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.09', 'groupIds': ['OG000', 'OG001'], 'paramType': "Cohen's d effect size at month 6", 'ciNumSides': 'TWO_SIDED', 'paramValue': '.76', 'pValueComment': 'a priori threshold set at p\\<0.05', 'estimateComment': 'Effect size was calculated using mean change scores (baseline to month 6) and standard error of change (baseline to month 6) for each group.', 'groupDescription': 'All analyses were performed using the intent-to-treat principle so that comparisons were made according to the assigned intervention group regardless of study completion.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'F(2,34)=2.55'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'Difference mean scaled scores (Color Word Interference Inhibition Scale) between groups over time using mixed effects models.\n\nThe Color Word Interference Inhibition Scale raw scores are converted to norm-referenced scaled scores adjusted for age and education. These scores are aligned with a population mean of 10, and standard deviation of 3. Higher scores indicate better executive function. Scaled scores were generated at baseline, month 3, and month 6 for each participant, and mean scaled scores were computed for each group at each time point.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Difference in Executive Function - Cognitive Flexibility, CWI (Color Word Interference Switching Scale)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CO-OP', 'description': 'Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.\n\nCO-OP'}, {'id': 'OG001', 'title': 'Attention Control', 'description': "The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.\n\nAttention Control"}], 'classes': [{'title': 'Baseline Scores', 'categories': [{'measurements': [{'value': '3.69', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '2.73', 'spread': '0.61', 'groupId': 'OG001'}]}]}, {'title': 'Month 3 Scores', 'categories': [{'measurements': [{'value': '8.82', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '3.00', 'spread': '0.93', 'groupId': 'OG001'}]}]}, {'title': 'Month 6 Scores', 'categories': [{'measurements': [{'value': '8.20', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '2.78', 'spread': '0.93', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.002', 'groupIds': ['OG000', 'OG001'], 'paramType': "Cohen's d effect size at month 6", 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.23', 'pValueComment': 'a priori threshold set at p\\<0.05', 'estimateComment': 'Effect size was calculated using mean change scores (baseline to month 6) and standard error of change (baseline to month 6) for each group.', 'groupDescription': 'All analyses were performed using the intent-to-treat principle so that comparisons were made according to assigned intervention group regardless of study completion.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'F(2,34)=7.83'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'Difference between groups in mean scaled scores (Color Word Interference Switching Scale) over time using mixed effects models.\n\nThe Cognitive Flexibility Scale raw scores were converted to norm-referenced scaled scores adjusted for age and education. These scores are aligned with a population mean of 10, and standard deviation of 3. Higher scores indicate better executive function. Scaled scores were generated at baseline, month 3, and month 6 for each participant, and mean scaled scores were computed for each group at each time point.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Differences in Apathy Symptoms Between Groups Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CO-OP', 'description': 'Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.\n\nCO-OP'}, {'id': 'OG001', 'title': 'Attention Control', 'description': "The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.\n\nAttention Control"}], 'classes': [{'title': 'Baseline Scores', 'categories': [{'measurements': [{'value': '25.79', 'spread': '2.04', 'groupId': 'OG000'}, {'value': '25.18', 'spread': '1.32', 'groupId': 'OG001'}]}]}, {'title': 'Month 3 Scores', 'categories': [{'measurements': [{'value': '25.18', 'spread': '1.65', 'groupId': 'OG000'}, {'value': '34.13', 'spread': '4.70', 'groupId': 'OG001'}]}]}, {'title': 'Month 6 Scores', 'categories': [{'measurements': [{'value': '21.38', 'spread': '1.34', 'groupId': 'OG000'}, {'value': '29.00', 'spread': '4.82', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.04', 'groupIds': ['OG000', 'OG001'], 'paramType': "Cohen's d effect size at month 6", 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.70', 'pValueComment': 'a priori threshold set at \\<0.05', 'estimateComment': 'Effect size was calculated using mean change scores (baseline to month 6) and standard error of change (baseline to month 6) for each group.', 'groupDescription': 'All analyses were performed using the intent-to-treat principle so that comparisons were made according to the assigned intervention group regardless of study completion.', 'statisticalMethod': 'repeated measures fixed effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'F(2,28)=3.61'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'Difference in mean Apathy Evaluation Scale total scores were examined between groups over time using repeated measures fixed effects models.\n\nThe Apathy Evaluation Scale measures lack of motivation or interest in goal-directed activities. The scale has 18 items yielding a total score of 18 (indicating absence of apathy) to 72 (indicating severe apathy). Total scores were generated for each participant at each time, and mean scores were computed for each group at each time point.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CO-OP', 'description': 'Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.\n\nCO-OP'}, {'id': 'FG001', 'title': 'Attention Control', 'description': "The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.\n\nAttention Control"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Refused assessments', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Recruitment period: July 2009 to June 2012. Participants with acute stroke were enrolled in inpatient rehabilitation at Mercy and Montefiore Hospital.', 'preAssignmentDetails': 'Excluded (n=30):\n\n* Insufficient cognitive impairment (n=15)\n* Mood/psychotic disorder (n=5)\n* Aphasia (n=3)\n* Recent drug/alcohol abuse (n=2)\n* Primary diagnosis not stroke (n=2)\n\nWithdrew prior to randomization (n=3)\n\n* Changed mind (n=1)\n* Family reasons (n=1)\n* Unexpected discharge (n=1)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CO-OP', 'description': 'Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.\n\nCO-OP'}, {'id': 'BG001', 'title': 'Attention Control', 'description': "The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.\n\nAttention Control"}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.87', 'spread': '16.59', 'groupId': 'BG000'}, {'value': '71.80', 'spread': '13.19', 'groupId': 'BG001'}, {'value': '67.33', 'spread': '15.41', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'African American', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Stroke onset', 'classes': [{'categories': [{'measurements': [{'value': '16.80', 'spread': '15.58', 'groupId': 'BG000'}, {'value': '18.47', 'spread': '21.29', 'groupId': 'BG001'}, {'value': '17.63', 'spread': '18.35', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Stroke onset is calculated from date of stroke to date of study admission.', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Stroke type', 'classes': [{'title': 'ischemic', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'hemorrhagic', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Hemisphere', 'classes': [{'title': 'right', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'left', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Stroke severity, NIHSS (National Institutes of Health Stroke Scale)', 'classes': [{'categories': [{'measurements': [{'value': '8.87', 'spread': '2.77', 'groupId': 'BG000'}, {'value': '5.87', 'spread': '2.72', 'groupId': 'BG001'}, {'value': '7.37', 'spread': '3.10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The NIHSS is composed of 11 items that are summed to yield a total score. Total scores range from 0 to 42; 0=no neurological impairment, 42=severe neurological impairment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Medical burden, CIRS (Cumulative Illness Rating Scale)', 'classes': [{'categories': [{'measurements': [{'value': '2.37', 'spread': '.47', 'groupId': 'BG000'}, {'value': '2.36', 'spread': '.57', 'groupId': 'BG001'}, {'value': '2.37', 'spread': '0.53', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Cumulative Illness Rating Scale records medical problems for 14 organ systems. The severity index is computed by averaging the impairment severity for each organ system (0=no impairment, 4=severe impairment), yielding an average severity index of 0 (no medical problems) to 4 (severe medical problems).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Cognitive status, EXIT (Quick Executive Interview)', 'classes': [{'categories': [{'measurements': [{'value': '8.13', 'spread': '3.00', 'groupId': 'BG000'}, {'value': '9.31', 'spread': '3.54', 'groupId': 'BG001'}, {'value': '8.72', 'spread': '3.28', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The EXIT is composed of 14 items that are summed to yield a total score ranging from 0 to 28. A total score of 0 typically indicates no executive impairment, while a total score of 28 indicates severe executive impairment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Communication status, BDAE (Boston Diagnositic Aphasia Examination Severity Index)', 'classes': [{'categories': [{'measurements': [{'value': '4.27', 'spread': '1.03', 'groupId': 'BG000'}, {'value': '4.67', 'spread': '.62', 'groupId': 'BG001'}, {'value': '4.47', 'spread': '0.86', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Boston Diagnostic Aphasia Examination is an aphasia severity rating scale ranging from 0-5, with 0 representing no usable speech or auditory comprehension and 5 representing minimal discernible speech impairments.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Functional Independence Measure', 'classes': [{'categories': [{'measurements': [{'value': '65.27', 'spread': '10.85', 'groupId': 'BG000'}, {'value': '62.60', 'spread': '16.56', 'groupId': 'BG001'}, {'value': '63.93', 'spread': '13.82', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Functional Independence Measure contains 18 items composed of 13 motor tasks and 5 cognitive tasks. A total scores is obtained (18-126), 18 represents complete dependence/total assistance and 126 represents complete independence with daily activities.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Inhibition, CWI (Color Word Interference)', 'classes': [{'categories': [{'measurements': [{'value': '4.85', 'spread': '4.10', 'groupId': 'BG000'}, {'value': '4.00', 'spread': '2.98', 'groupId': 'BG001'}, {'value': '4.39', 'spread': '3.50', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Inhibition Scale raw scores are converted to norm-referenced scaled scores adjusted for age and education. These scores are aligned with a population mean of 10, and standard deviation of 3. Higher scores indicate better executive function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Cognitive flexibility, CWI (Color Word Interference)', 'classes': [{'categories': [{'measurements': [{'value': '3.69', 'spread': '2.36', 'groupId': 'BG000'}, {'value': '2.73', 'spread': '2.34', 'groupId': 'BG001'}, {'value': '3.18', 'spread': '2.36', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Cognitive Flexibility Scale raw scores are converted to norm-referenced scaled scores adjusted for age and education. These scores are aligned with a population mean of 10, and standard deviation of 3. Higher scores indicate better executive function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Depressive symptoms, HamD (Hamilton Rating Scale for Depression)', 'classes': [{'categories': [{'measurements': [{'value': '6.71', 'spread': '4.36', 'groupId': 'BG000'}, {'value': '6.75', 'spread': '4.53', 'groupId': 'BG001'}, {'value': '6.73', 'spread': '4.35', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Hamilton Depression Rating Scale is composed of 17 items that are summed to yield a total score ranging from 0 to 52. A total score of 0 typically indicates no depressive symptoms; 52 indicates severe depressive symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Apathy, AES', 'classes': [{'categories': [{'measurements': [{'value': '25.79', 'spread': '7.62', 'groupId': 'BG000'}, {'value': '25.18', 'spread': '4.40', 'groupId': 'BG001'}, {'value': '25.52', 'spread': '6.29', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Apathy Evaluation Scale measures motivation or interest in goal-directed activities. The scale has 18 items with a total score of 18 (absence of apathy) to 72 (severe apathy).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-05', 'studyFirstSubmitDate': '2016-04-25', 'resultsFirstSubmitDate': '2016-07-08', 'studyFirstSubmitQcDate': '2016-04-26', 'lastUpdatePostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-08-27', 'studyFirstPostDateStruct': {'date': '2016-04-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time', 'timeFrame': 'Baseline, rehabilitation discharge, month 3, month 6', 'description': 'Difference between groups in mean scores (computed from Functional Independence Measure total scores) over time were examined with mixed effects models.\n\nThe Functional Independence Measure contains 18 items with a total score ranging from 18-126 is obtained (18=complete dependence/total assistance with basic self-care and mobility activities; 126=complete independence with basic self-care and mobility activities). Total scores were calculated at baseline, rehabilitation discharge, month 3, and month 6 for each participant, and mean total scores were calculated fro each group at each time point.'}], 'secondaryOutcomes': [{'measure': 'Difference in Executive Function- Inhibition, CWI (Color Word Interference Inhibition Scale)', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'Difference mean scaled scores (Color Word Interference Inhibition Scale) between groups over time using mixed effects models.\n\nThe Color Word Interference Inhibition Scale raw scores are converted to norm-referenced scaled scores adjusted for age and education. These scores are aligned with a population mean of 10, and standard deviation of 3. Higher scores indicate better executive function. Scaled scores were generated at baseline, month 3, and month 6 for each participant, and mean scaled scores were computed for each group at each time point.'}, {'measure': 'Difference in Executive Function - Cognitive Flexibility, CWI (Color Word Interference Switching Scale)', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'Difference between groups in mean scaled scores (Color Word Interference Switching Scale) over time using mixed effects models.\n\nThe Cognitive Flexibility Scale raw scores were converted to norm-referenced scaled scores adjusted for age and education. These scores are aligned with a population mean of 10, and standard deviation of 3. Higher scores indicate better executive function. Scaled scores were generated at baseline, month 3, and month 6 for each participant, and mean scaled scores were computed for each group at each time point.'}, {'measure': 'Differences in Apathy Symptoms Between Groups Over Time', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'Difference in mean Apathy Evaluation Scale total scores were examined between groups over time using repeated measures fixed effects models.\n\nThe Apathy Evaluation Scale measures lack of motivation or interest in goal-directed activities. The scale has 18 items yielding a total score of 18 (indicating absence of apathy) to 72 (indicating severe apathy). Total scores were generated for each participant at each time, and mean scores were computed for each group at each time point.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Stroke', 'Rehabilitation', 'Cognition', 'Intervention', 'Strategy training'], 'conditions': ['CO-OP', 'Attention Control']}, 'referencesModule': {'references': [{'pmid': '29552996', 'type': 'DERIVED', 'citation': 'Kringle EA, Terhorst L, Butters MA, Skidmore ER. Clinical Predictors of Engagement in Inpatient Rehabilitation Among Stroke Survivors With Cognitive Deficits: An Exploratory Study. J Int Neuropsychol Soc. 2018 Jul;24(6):572-583. doi: 10.1017/S1355617718000085. Epub 2018 Mar 19.'}]}, 'descriptionModule': {'briefSummary': 'Cognitive impairments occur frequently after stroke, and are associated with significant long-term activities of daily living (ADL) disability and poor quality of life. This research study will undertake an innovative approach addressing cognitive impairments, by examining a new patient-centered functionally-relevant rehabilitation intervention that teaches individuals with cognitive impairments to manage their deficits to reduce ADL disability.', 'detailedDescription': 'Cognitive impairments are characterized by problems sustaining attention in distracting conditions, shifting attention between different task demands, and using working memory to consistently execute intended actions, and as a result limit the ability to execute routine ADLs. Presently there are no interventions that have demonstrated robust effectiveness in reducing disability among individuals with cognitive impairments after stroke. Recent findings suggest that individuals with cognitive impairments may experience ADL disability in part because they have difficulty engaging in, and benefiting from rehabilitation programs as they are currently delivered. In other words, individuals with cognitive impairment, due to the nature of their impairments, have difficulty learning and applying adaptive strategies as they are currently provided during traditional rehabilitation training. Therefore, interventions that train individuals with cognitive impairments a new way to learn and apply adaptive strategies may help them benefit from rehabilitation programs and reduce long-term disability. Cognitive Orientation to daily Occupation Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Therefore, CO-OP teaches individuals to "take charge" of their rehabilitation, and develop adaptive behaviors to "work around" cognitive impairments to meet their goals. The proposed project examines whether CO-OP facilitates reductions in ADL disability and improvements in rehabilitation engagement among individuals with cognitive impairments after acute stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primary diagnosis of acute stroke\n* admission to acute inpatient rehabilitation\n* impairment in cognitive functions (Quick Executive Interview ≥ 3)\n\nExclusion Criteria:\n\n* dementia diagnosis (as indicated in the medical record)\n* severe aphasia as indicated by score ≥ 2 on the Boston Diagnostic Aphasia Examination (3rd Edition) Severity Rating Scale (BDAE-3)\n* current major depressive disorder (unless treated and in partial remission), bipolar or any other psychotic disorder (Primary Care Evaluation of Mental Disorders)\n* drug or alcohol abuse within 3 months (Mini-International Neuropsychiatric Interview)\n* anticipated length of stay less than 5 days'}, 'identificationModule': {'nctId': 'NCT02755805', 'acronym': 'CO-OP', 'briefTitle': 'CO-OPerative Training for Stroke Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'CO-OPerative Training For Stroke Rehabilitation: A Phase II Trial Examining Meta-Cognitive Strategy Training in Acute Stroke Rehabilitation', 'orgStudyIdInfo': {'id': 'PRO09010473'}, 'secondaryIdInfos': [{'id': 'K12HD055931', 'link': 'https://reporter.nih.gov/quickSearch/K12HD055931', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CO-OP', 'description': 'Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.', 'interventionNames': ['Behavioral: CO-OP']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Attention Control', 'description': "The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.", 'interventionNames': ['Behavioral: Attention Control']}], 'interventions': [{'name': 'CO-OP', 'type': 'BEHAVIORAL', 'otherNames': ['Strategy Training'], 'armGroupLabels': ['CO-OP']}, {'name': 'Attention Control', 'type': 'BEHAVIORAL', 'otherNames': ['Reflective Listening'], 'armGroupLabels': ['Attention Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15260', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Elizabeth R Skidmore, PhD, OTR/L', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no current plan to share individual participant data at this time.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chair and Associate Professor', 'investigatorFullName': 'Elizabeth R. Skidmore, PhD, OTR/L', 'investigatorAffiliation': 'University of Pittsburgh'}}}}