Cognitive Oriented Strategy Training Augmented Rehabilitation (COSTAR) Treatment Approach for Stroke (COSTAR)

• ClinicalTrials.gov Identifier: NCT01910454
• Recruitment Status: Completed
• First Posted: July 29, 2013
• Last Update Posted: November 28, 2018
• Sponsor: Washington University School of Medicine
• Information provided by (Responsible Party): Washington University School of Medicine

Study Description

Brief Summary:

Stroke is the most serious disabling condition in the United States and the developed world. Novel stroke rehabilitation approaches, such as task-specific training, have shown promise in improving an individual's recovery in the rehabilitation setting; however, evidence suggests that these improvements are not generalized or transferred to the home, community, or work settings. Thus, these interventions usually do not impact overall health and participation outcomes. This research study seeks to improve task-specific training as a stroke rehabilitation approach by integrating it with evidence-based cognitive-oriented strategies which have shown great promise as a way to address the limitations of task-specific training. The new treatment protocol is called Cognitive-Oriented Strategy Training Augmented Rehabilitation, or COSTAR. The hypothesis of this study is that COSTAR will result in more efficient functional skill acquisition, better long-term retention of skills learned, and generalization and transfer of skills learned to home, community, and work settings.

Condition or disease	Intervention/treatment	Phase
Stroke	Behavioral: Cognitive-Oriented Strategy Augmented Rehabilitation (COSTAR); Behavioral: Task Specific Training (TST)	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 47 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Cognitive Oriented Strategy Training Augmented Rehabilitation (COSTAR) Treatment Approach for Stroke
• Actual Study Start Date: August 2013
• Actual Primary Completion Date: March 2016
• Actual Study Completion Date: March 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Cognitive-Oriented Strategy Augmented Rehabilitation (COSTAR)	Behavioral: Cognitive-Oriented Strategy Augmented Rehabilitation (COSTAR); The protocol for COSTAR is based on the Cognitive-Orientation to daily Occupational Performance Intervention (CO-OP) approach which includes the following components: (1) Guided discovery - a process created by CO-OP to make certain that participants discover the strategies that will solve their own performance problems ; (2) Cognitive strategy use - participants are taught a global problem-solving strategy and are enabled to discover additional domain specific strategies that will support their skill acquisition and performance competence; and (3) Dynamic performance analysis - an observation-based process of identifying performance problems or performance breakdown. These three components from CO-OP are overlaid on the TST intervention protocol described above to address the overall hypothesis of this study: that an evidence-based stroke rehabilitation treatment protocol (task-specific training) can be enhanced when augmented with the catalyst of cognitive-oriented strategy use.
Active Comparator: Task Specific Training (TST)	Behavioral: Task Specific Training (TST); The protocol for task-specific training is based on criteria established by Winstein and Wolf (2008) who define task-specific training (TST) as a top-down approach to rehabilitation that is based on recent integrated models of motor control, motor learning, and behavioral neuroscience and that addresses skill acquisition of performance of meaningful and relevant tasks (Winstein and Wolf, 2008). Winstein and Wolf use current theory to identify three key ingredients for a task-specific training (pg 269): (1) Challenging enough to require new learning, and engagement with attention to solve the motor problem; (2) Progressive and optimally adapted such that over practice, the task-demand is optimally adapted to the patient's capability and the environmental context. The task should not be too simple or too repetitive nor too difficult; and (3) Interesting enough to invoke active participation through engagement in meaningful activity.; Other Names: Task Oriented Training; Specific Task Training

Outcome Measures

Primary Outcome Measures :

1. Canadian Occupational Performance Measure (COPM) [ Time Frame: Change from baseline to post-intervention (12 weeks) ]
2. Performance Quality Rating Scale (PQRS) [ Time Frame: Change from baseline to post-intervention (12 weeks) ]

Secondary Outcome Measures :

1. Reintegration to Normal Living Index (RNLI) [ Time Frame: Change from baseline to post-intervention (12 weeks) ]
2. Patient Reported Outcomes Measurement System (PROMIS-57) [ Time Frame: Change from baseline to post-intervention (12 weeks) ]
3. Stroke Impact Scale (SIS) [ Time Frame: Change from baseline to post-intervention (12 weeks) ]
4. Patient Health Questionnaire (PHQ-9) [ Time Frame: Change from baseline to post-intervention (12 weeks) ]
5. Self-Efficacy Gauge (SEG) [ Time Frame: Change from baseline to post-intervention (12 weeks) ]
6. Activity Card Sort (ACS) [ Time Frame: Change from baseline to post-intervention (12 weeks) ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. age 18 or older;
2. have completed all physician recommended rehabilitation and currently not receiving rehabilitation services;
3. at least one-month post-stroke;
4. have self-reported unmet functional goals; and
5. NIH Stroke Scale (NIHSS) total score of 2-12.

Exclusion Criteria:

1. have sustained a hemorrhagic stroke;
2. NIH Stroke Scale (NIHSS) aphasia rating of 1 or more (impaired speech);
3. MoCA cognitive screen score of less than 21 (impaired general cognitive ability);
4. neurological diagnoses other than stroke;
5. major psychiatric illness (bipolar disorder, OCD, panic disorder, PTSD, and/or borderline personality disorder);
6. no major depressive symptoms (PHQ-9 < 20);
7. a score of 6 or less on the CIHI aphasia screen combined items 64 and 66;
8. terminal illness;
9. blindness; and
10. non-English speaking.

Contacts and Locations

Locations

United States, Missouri

Washington University in St Louis: Program in Occupational Therapy

Saint Louis, Missouri, United States, 63108

Sponsors and Collaborators

Washington University School of Medicine

Investigators

• Principal Investigator: Timothy J Wolf, OTD, MSCI, OTR/L; Washington University School of Medicine

More Information

Publications:

Winstein, Carolee J, & Wolf, Steven L. (2009). Task-oriented training to promote upper extremity recovery. Stroke Recovery & Rehabilitation, 267-290.

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT01910454
• Other Study ID Numbers: R03HD069626 ( U.S. NIH Grant/Contract )
• First Posted: July 29, 2013
• Last Update Posted: November 28, 2018
• Last Verified: November 2018

Keywords provided by Washington University School of Medicine:

Stroke; Occupational Therapy; Cognition

Additional relevant MeSH terms:

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases