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

Primary Purpose

Stroke

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cognitive-Oriented Strategy Augmented Rehabilitation (COSTAR)
Task Specific Training (TST)
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Occupational Therapy, Cognition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Washington University in St Louis: Program in Occupational Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive-Oriented Strategy Augmented Rehabilitation (COSTAR)

Task Specific Training (TST)

Arm Description

Outcomes

Primary Outcome Measures

Canadian Occupational Performance Measure (COPM)
Performance Quality Rating Scale (PQRS)

Secondary Outcome Measures

Reintegration to Normal Living Index (RNLI)
Patient Reported Outcomes Measurement System (PROMIS-57)
Stroke Impact Scale (SIS)
Patient Health Questionnaire (PHQ-9)
Self-Efficacy Gauge (SEG)
Activity Card Sort (ACS)

Full Information

First Posted
July 22, 2013
Last Updated
November 27, 2018
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01910454
Brief Title
Cognitive Oriented Strategy Training Augmented Rehabilitation (COSTAR) Treatment Approach for Stroke
Acronym
COSTAR
Official Title
Cognitive Oriented Strategy Training Augmented Rehabilitation (COSTAR) Treatment Approach for Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
August 2013 (Actual)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Occupational Therapy, Cognition

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive-Oriented Strategy Augmented Rehabilitation (COSTAR)
Arm Type
Experimental
Arm Title
Task Specific Training (TST)
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-Oriented Strategy Augmented Rehabilitation (COSTAR)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Task Specific Training (TST)
Other Intervention Name(s)
Task Oriented Training, Specific Task Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Canadian Occupational Performance Measure (COPM)
Time Frame
Change from baseline to post-intervention (12 weeks)
Title
Performance Quality Rating Scale (PQRS)
Time Frame
Change from baseline to post-intervention (12 weeks)
Secondary Outcome Measure Information:
Title
Reintegration to Normal Living Index (RNLI)
Time Frame
Change from baseline to post-intervention (12 weeks)
Title
Patient Reported Outcomes Measurement System (PROMIS-57)
Time Frame
Change from baseline to post-intervention (12 weeks)
Title
Stroke Impact Scale (SIS)
Time Frame
Change from baseline to post-intervention (12 weeks)
Title
Patient Health Questionnaire (PHQ-9)
Time Frame
Change from baseline to post-intervention (12 weeks)
Title
Self-Efficacy Gauge (SEG)
Time Frame
Change from baseline to post-intervention (12 weeks)
Title
Activity Card Sort (ACS)
Time Frame
Change from baseline to post-intervention (12 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy J Wolf, OTD, MSCI, OTR/L
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University in St Louis: Program in Occupational Therapy
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Winstein, Carolee J, & Wolf, Steven L. (2009). Task-oriented training to promote upper extremity recovery. Stroke Recovery & Rehabilitation, 267-290.
Results Reference
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Cognitive Oriented Strategy Training Augmented Rehabilitation (COSTAR) Treatment Approach for Stroke

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