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

The Washington University

Status and phase: Completed; Phase 1

Conditions: Stroke

Treatments: Behavioral: Cognitive-Oriented Strategy Augmented Rehabilitation (COSTAR); Behavioral: Task Specific Training (TST)

Study type: Interventional

Funder types: Other

Identifiers

NCT01910454

R03HD069626

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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47 participants in 2 patient groups

Cognitive-Oriented Strategy Augmented Rehabilitation (COSTAR)

Experimental group

Treatment:

Behavioral: Cognitive-Oriented Strategy Augmented Rehabilitation (COSTAR)

Task Specific Training (TST)

Active Comparator group

Treatment:

Behavioral: Task Specific Training (TST)