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

NCT01910454 | Completed Phase 1

• 1 other identifier: R03HD069626
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke; Occupational Therapy; Cognition

Outcome Measures

Primary Outcomes (2)

• Canadian Occupational Performance Measure (COPM)

  Change from baseline to post-intervention (12 weeks)

• Performance Quality Rating Scale (PQRS)

  Change from baseline to post-intervention (12 weeks)

Secondary Outcomes (6)

• Reintegration to Normal Living Index (RNLI)

  Change from baseline to post-intervention (12 weeks)

• Patient Reported Outcomes Measurement System (PROMIS-57)

  Change from baseline to post-intervention (12 weeks)

• Stroke Impact Scale (SIS)

  Change from baseline to post-intervention (12 weeks)

• Patient Health Questionnaire (PHQ-9)

  Change from baseline to post-intervention (12 weeks)

• Self-Efficacy Gauge (SEG)

  Change from baseline to post-intervention (12 weeks)

Study Arms (2)

Cognitive-Oriented Strategy Augmented Rehabilitation (COSTAR)

EXPERIMENTAL

Behavioral: Cognitive-Oriented Strategy Augmented Rehabilitation (COSTAR)

Task Specific Training (TST)

ACTIVE COMPARATOR

Behavioral: Task Specific Training (TST)

Interventions

Cognitive-Oriented Strategy Augmented Rehabilitation (COSTAR) BEHAVIORAL

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.

Cognitive-Oriented Strategy Augmented Rehabilitation (COSTAR)

Task Specific Training (TST) BEHAVIORAL

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.

Also known as: Task Oriented Training, Specific Task Training

Task Specific Training (TST)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University in St Louis: Program in Occupational Therapy

St Louis, Missouri, 63108, United States

Location

Related Publications (1)

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

  BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Timothy J Wolf, OTD, MSCI, OTR/L

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2013
• First Posted: July 29, 2013
• Study Start: August 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: November 28, 2018

Record last verified: 2018-11

Locations

US (1)