CO-OPerative Training for Stroke Rehabilitation (CO-OP)

October 5, 2017 updated by: Elizabeth R. Skidmore, PhD, OTR/L, University of Pittsburgh

CO-OPerative Training For Stroke Rehabilitation: A Phase II Trial Examining Meta-Cognitive Strategy Training in Acute Stroke Rehabilitation

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.

Study Overview

Status

Completed

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15260
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.
Other Names:
  • Strategy Training
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.
Other Names:
  • Reflective Listening

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

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

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

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
Difference in Executive Function - Cognitive Flexibility, CWI (Color Word Interference Switching Scale)
Time Frame: Baseline, 3 months, 6 months

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
Differences in Apathy Symptoms Between Groups Over Time
Time Frame: Baseline, 3 months, 6 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Elizabeth R Skidmore, PhD, OTR/L, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

April 25, 2016

First Submitted That Met QC Criteria

April 26, 2016

First Posted (Estimate)

April 29, 2016

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

October 5, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There is no current plan to share individual participant data at this time.

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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