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Completed

NCT Number: NCT02755805

CO-OPerative Training for 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.

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Key information

Conditions

CO-OP Attention Control Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CO-OP

Behavioral

Other names: Strategy Training

Attention Control

Behavioral

Other names: Reflective Listening

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

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

Acronym: CO-OP

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Apr 29, 2016
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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