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CO-OPerative Training for Stroke Rehabilitation

NCT ID: NCT02755805

Last Updated: 2017-11-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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CO-OP Attention Control

Keywords

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Stroke Rehabilitation Cognition Intervention Strategy training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

CO-OP

Intervention Type BEHAVIORAL

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.

Group Type PLACEBO_COMPARATOR

Attention Control

Intervention Type BEHAVIORAL

Interventions

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CO-OP

Intervention Type BEHAVIORAL

Attention Control

Intervention Type BEHAVIORAL

Other Intervention Names

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Strategy Training Reflective Listening

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Elizabeth R. Skidmore, PhD, OTR/L

Chair and Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elizabeth R Skidmore, PhD, OTR/L

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 29552996 (View on PubMed)

Other Identifiers

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K12HD055931

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PRO09010473

Identifier Type: -

Identifier Source: org_study_id