- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02755805
CO-OPerative Training for Stroke Rehabilitation (CO-OP)
CO-OPerative Training For Stroke Rehabilitation: A Phase II Trial Examining Meta-Cognitive Strategy Training in Acute Stroke Rehabilitation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15260
- University of Pittsburgh
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- primary diagnosis of acute stroke
- admission to acute inpatient rehabilitation
- impairment in cognitive functions (Quick Executive Interview ≥ 3)
Exclusion Criteria:
- dementia diagnosis (as indicated in the medical record)
- severe aphasia as indicated by score ≥ 2 on the Boston Diagnostic Aphasia Examination (3rd Edition) Severity Rating Scale (BDAE-3)
- current major depressive disorder (unless treated and in partial remission), bipolar or any other psychotic disorder (Primary Care Evaluation of Mental Disorders)
- drug or alcohol abuse within 3 months (Mini-International Neuropsychiatric Interview)
- anticipated length of stay less than 5 days
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: CO-OP
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.
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Other Names:
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Placebo Comparator: Attention Control
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.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time
Time Frame: Baseline, rehabilitation discharge, month 3, month 6
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Difference between groups in mean scores (computed from Functional Independence Measure total scores) over time were examined with mixed effects models. The 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. |
Baseline, rehabilitation discharge, month 3, month 6
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in Executive Function- Inhibition, CWI (Color Word Interference Inhibition Scale)
Time Frame: Baseline, 3 months, 6 months
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Difference mean scaled scores (Color Word Interference Inhibition Scale) between groups over time using mixed effects models. The 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. |
Baseline, 3 months, 6 months
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Difference in Executive Function - Cognitive Flexibility, CWI (Color Word Interference Switching Scale)
Time Frame: Baseline, 3 months, 6 months
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Difference between groups in mean scaled scores (Color Word Interference Switching Scale) over time using mixed effects models. The 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. |
Baseline, 3 months, 6 months
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Differences in Apathy Symptoms Between Groups Over Time
Time Frame: Baseline, 3 months, 6 months
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Difference in mean Apathy Evaluation Scale total scores were examined between groups over time using repeated measures fixed effects models. The 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. |
Baseline, 3 months, 6 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Elizabeth R Skidmore, PhD, OTR/L, University of Pittsburgh
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO09010473
- K12HD055931 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on CO-OP
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Federal University of Minas GeraisCompletedAttention Deficit and Disruptive Behavior Disorders | Motor Skills DisordersBrazil
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Hopitaux de Saint-MauriceInstitut National de la Santé Et de la Recherche Médicale, France; Ministry... and other collaboratorsCompleted
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University Hospital, ToulouseTerminatedCerebrovascular AccidentFrance
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Hopitaux de Saint-MauriceCompletedAcquired Brain InjuryFrance
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University of British ColumbiaWaterloo FoundationUnknown
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Sunnybrook Health Sciences CentreUniversity Health Network, Toronto; University of Toronto; West Park Healthcare... and other collaboratorsCompleted
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ZEYNEP KOLİTCompletedCerebral Palsy | Cognitive OrientationTurkey
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Eastern Mediterranean UniversityCompletedDown Syndrome, Trisomy 21Cyprus
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St. John's Rehab HospitalSunnybrook Health Sciences Centre; Washington University School of Medicine; University...CompletedStrokeUnited States, Canada
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Shirley Ryan AbilityLabMidwestern UniversityCompletedCerebral Vascular AccidentUnited States