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Completed

NCT Number: NCT01910454

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Washington University in St Louis: Program in Occupational Therapy

St Louis, Missouri, 63108, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Other names: Task Oriented Training, Specific Task Training

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Acronym: COSTAR

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jul 29, 2013
Registry last updated
Nov 28, 2018

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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