StrokePhase 1COSTARNCT01910454
Cognitive Oriented Strategy Training Augmented Rehabilitation (COSTAR) Treatment Approach for Stroke
A Phase 1 study testing Cognitive-Oriented Strategy Augmented Rehabilitation (COSTAR) and Task Specific Training (TST) in people with Stroke, run by Washington University School of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Cognitive-Oriented Strategy Augmented Rehabilitation (COSTAR) and Task Specific Training (TST)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Mar 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
Show all 10Show fewer
- a score of 6 or less on the CIHI aphasia screen combined items 64 and 66;
- terminal illness;
- blindness; and
- non-English speaking.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in St Louis: Program in Occupational Therapy
St Louis, Missouri, 63108
About this study
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
- Being tested
- Cognitive-Oriented Strategy Augmented Rehabilitation (COSTAR), Task Specific Training (TST)
- Keywords
- Stroke, Occupational Therapy, Cognition
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Oriented Strategy Augmented Rehabilitation (COSTAR)Behavioural
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)Behavioural
Also called Task Oriented Training, Specific Task Training
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-Oriented Strategy Augmented Rehabilitation (COSTAR) | Experimental | Not described Receives: Behavioral: Cognitive-Oriented Strategy Augmented Rehabilitation (COSTAR) |
| Task Specific Training (TST) | Active comparator | Not described Receives: Behavioral: Task Specific Training (TST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Canadian Occupational Performance Measure (COPM)
Measured: Change from baseline to post-intervention (12 weeks)
Performance Quality Rating Scale (PQRS)
Measured: Change from baseline to post-intervention (12 weeks)
Secondary outcomes (6)
Reintegration to Normal Living Index (RNLI)
Measured: Change from baseline to post-intervention (12 weeks)
Patient Reported Outcomes Measurement System (PROMIS-57)
Measured: Change from baseline to post-intervention (12 weeks)
Stroke Impact Scale (SIS)
Measured: Change from baseline to post-intervention (12 weeks)
Patient Health Questionnaire (PHQ-9)
Measured: Change from baseline to post-intervention (12 weeks)
Self-Efficacy Gauge (SEG)
Measured: Change from baseline to post-intervention (12 weeks)
Activity Card Sort (ACS)
Measured: Change from baseline to post-intervention (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy J Wolf, OTD, MSCI, OTR/L, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01910454
- Sponsor's protocol ID
- R03HD069626
- Acronym
- COSTAR
- Status last verified
- Nov 2018
- First submitted
- 22 Jul 2013
- Last updated
- 28 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Winstein, Carolee J, & Wolf, Steven L. (2009). Task-oriented training to promote upper extremity recovery. Stroke Recovery & Rehabilitation, 267-290.
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Oriented Strategy Training Augmented Rehabilitation (COSTAR) Treatment Approach for Stroke
- ClinicalTrials.gov ID
- NCT01910454
- Acronym / sponsor ID
- COSTAR / R03HD069626
- Conditions
- Stroke
- Keywords
- Stroke, Occupational Therapy, Cognition
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Aug 2013 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 29 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Cognitive-Oriented Strategy Augmented Rehabilitation (COSTAR) |
| Task Specific Training (TST)Also: Task Oriented Training, Specific Task TrainingThe 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. | Behavioural | Task Specific Training (TST) |
Primary outcome
Canadian Occupational Performance Measure (COPM)
Time frame: Change from baseline to post-intervention (12 weeks)
Performance Quality Rating Scale (PQRS)
Time frame: Change from baseline to post-intervention (12 weeks)
6 secondary outcomes
Reintegration to Normal Living Index (RNLI)
Time frame: Change from baseline to post-intervention (12 weeks)
Patient Reported Outcomes Measurement System (PROMIS-57)
Time frame: Change from baseline to post-intervention (12 weeks)
Stroke Impact Scale (SIS)
Time frame: Change from baseline to post-intervention (12 weeks)
Patient Health Questionnaire (PHQ-9)
Time frame: Change from baseline to post-intervention (12 weeks)
Self-Efficacy Gauge (SEG)
Time frame: Change from baseline to post-intervention (12 weeks)
Activity Card Sort (ACS)
Time frame: Change from baseline to post-intervention (12 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2018.
- BackgroundWinstein, Carolee J, & Wolf, Steven L. (2009). Task-oriented training to promote upper extremity recovery. Stroke Recovery & Rehabilitation, 267-290.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy J Wolf, OTD, MSCI, OTR/L principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cognitive-Oriented Strategy Augmented Rehabilitation (COSTAR) and Task Specific Training (TST) in people with Stroke, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Canadian Occupational Performance Measure (COPM) (time frame: Change from baseline to post-intervention (12 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01910454, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2018.