Metacognitive-Strategy Training in Sub-Acute Stroke

January 5, 2026 updated by: Timothy J Wolf, University of Missouri-Columbia

Efficacy of Metacognitive-Strategy Training to Improve Activity Performance and Reduce Motor Impairment in Sub-Acute Stroke

The long-term goal of this research is to improve activity performance and reduce motor impairment in individuals with stroke. Contemporary stroke rehabilitation focuses on remediation of post-stroke impairments with a false assumption that reduction in impairments will automatically lead to improvements in activity performance. Specifically, stroke rehabilitation is focused primarily on the use of task-specific training (TST), which recent research has found to yield negligible improvement in upper extremity motor function often consistent with or less than control conditions. These protocols are time intensive and often do not lead to transfer of training effects to improvement in activity performance. This is a common issue that has been evidenced in longitudinal studies of individuals with stroke; over half of stroke survivors continue to be dependent on others for the most basic of life activities after rehabilitation. Decreases in activity performance further contribute to lower life satisfaction, quality of life, and participation in daily life. The goal of this proposed project is to evaluate the efficacy of a clinically-feasible metacognitive strategy training (MCST) intervention, the Cognitive Orientation to daily Occupational Performance (CO-OP) approach, to improve activity performance and reduce stroke impairment for individuals with sub-acute stroke.

Recent evidence highlights two primary issues in stroke rehabilitation. 1) Interventions are needed that directly target activity performance. Gains in upper extremity function, even using the most contemporary approaches, are not translating to meaningful gains in activity performance. 2) Interventions need to be clinically feasible for future implementation. In recent stroke rehabilitation clinical trials, participants received an average of over 30 hours of therapy in only one treatment modality. Individuals in stroke rehabilitation receive a median of only 6 outpatient visits across all health care specialties combined (OT, PT, SLP, physiatrist).

Metacognitive strategy training (MCST), specifically the Cognitive Orientation to daily Occupational Performance (CO-OP) approach, is a potential solution to address both of these gaps. CO-OP is a performance-based, problem-solving approach that enables participants to improve task performance through cognitive strategy use. In the exploratory clinical trial for individuals with sub-acute stroke (n=26), the study compared ten, 45-minute sessions of MCST (CO-OP) with dose-matched outpatient usual care outpatient occupational therapy (OT). The MCST (CO-OP) group demonstrated a large effect over usual care on objective measures of trained functional activities (d=1.6) and untrained functional activities (d = 1.1). The MCST group also demonstrated a moderate effect over usual care outpatient OT on improving motor function (r = 0.3).

The goal of this proposed project is to determine the efficacy of MCST to improve activity performance and to reduce motor impairments in individuals with subacute stroke. A single-blind, parallel, randomized clinical trial will be conducted with individuals with sub-acute stroke. Participants will be randomized to a 10-session MCST (CO-OP) treatment group or to a dose matched usual care outpatient OT control group. Data will be collected pre-intervention, post-intervention, and at 3-months post-intervention assessment. Our central research hypothesis is that MCST will produce a significant improvement on objective and subjective measures of activity performance (trained and untrained goals) and reduce motor impairment in comparison to a usual care OT group.

Objective 1: Evaluate the efficacy of MCST to improve subjective and objective activity performance in individuals with subacute stroke.

Primary Endpoint: MCST will have a greater positive effect compared to usual care OT on subjective and objective activity performance of trained goals.

Primary Endpoint: MCST will have a greater positive effect compared to usual care OT on subjective and objective activity performance of untrained activity goals to demonstrate transfer of the treatment effect.

Secondary Endpoint: MCST will have a greater positive effect compared to usual care OT on subjective stroke recovery (participation and role functioning) Objective 2: Evaluate the efficacy of MCST to improve motor function in individuals with subacute stroke.

Primary Endpoint: MCST group will have a greater positive effect compared to usual care OT on reducing motor impairment.

Secondary Endpoint: MCST will have a greater positive effect compared to usual care OT on subjective stroke recovery (physical functioning)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Missouri
      • Columbia, Missouri, United States, 65211
        • University of Missouri: Department of Occupational Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • less than 9 months post-stroke
  • adults age 40-85
  • completed inpatient rehabilitation services (if recommended)
  • living in the community with or without caregiver support (i.e., not living in a skilled nursing facility)
  • ability to read, write, and speak English
  • self-identified activity performance goals per the Canadian Occupational Performance Measure (COPM)
  • upper extremity hemiparesis as indicated by a score of 1-3 on the NIHSS motor arm score, documented in acute therapy evaluation, and/or per self- report of the participant.
  • absence of moderate or severe aphasia as indicated by a National Institutes of Health Stroke Scale (NIHSS) aphasia score of 1 or less or documented in acute therapy evaluation

Exclusion Criteria:

  • inability to provide informed consent
  • severe depressive symptoms as indicated by a score >21 on the Patient Health Questionnaire (PHQ-9)
  • dementia symptoms as indicated by a score of <23 on the Montreal Cognitive Assessment (MoCA)
  • additional neurological diagnoses identified by medical chart review (e.g., brain malignancy)
  • no voluntary movement in affected upper extremity as indicated by a score of 4 on the NIHSS motor arm score or documented in acute therapy evaluation
  • anosognosia as indicated by an inability to identify activity performance problems on the COPM
  • any other condition not otherwise specified that the PI determines would render participation in this study as unsafe
  • any medical condition that the medial monitor determines would render participation in this study as unsafe

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Usual Care Occupational Therapy-Outpatient
Behavioral: Usual Care Occupational Therapy-Outpatient
The control group in the proposed study will receive usual care occupational therapy services. The dosage between the experimental group and usual care will be identical with each group receiving ten 45- minute treatment sessions. The treating therapists will be unfamiliar with the experimental group intervention to avoid contamination. Each therapist will be instructed to provide care in the same manner as they typically provide in day-to-day practice for patients with similar characteristics as those in the study. The therapists will be encouraged to provide home action plans to participants. Usual care services will be monitored through a log of number of sessions, time spent in each session, and what activities were the focus of each session. The therapists will be instructed that they can address any participant goals they wish other than transfer goals identified by the participant.
Experimental: Cognitive Orientation to daily Occupational Performance
Behavioral: Cognitive Orientation to daily Occupational Performance
The Cognitive Orientation to daily Occupational Performance (CO-OP) approach was developed within the field of occupational therapy and is a performance-based, problem-solving approach to address activity performance limitations. Subjects will be taught to use the global problem-solving strategy of Goal-Plan-Do-Check: identifying a specific goal (Goal), outlining a practical plan for reaching that goal (Plan), accurately performing the plan (Do), and analyzing whether the plan led to achievement of the goal and altering the plan accordingly (Check). The Goal-Plan-Do-Check process will be iteratively applied to each of the activity goals. Therapists will use guided discovery to allow the subject to self-identify their own potential solutions within an activity (develop the plan). The therapists will be instructed that they can address any participant goals they wish other than transfer goals identified by the participant.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Performance Quality Rating Scale (PQRS)
Time Frame: Change in baseline to follow-up (12 weeks after post-intervention assessment)
The PQRS is an observational, objective method of scoring subject activity performance of goals set via the COPM. A blind, trained rater external to the research study team will view video recordings of each subject performing goals. Each goal is rated on a scale of 1 (no activity criteria were met) to 10 (all activity criteria were met). The final score used in the analysis will be an average of all 5 goals.
Change in baseline to follow-up (12 weeks after post-intervention assessment)
Canadian Occupational Performance Measure (COPM)
Time Frame: Change in baseline to follow-up average performance score (12 weeks after post-intervention assessment)
The COPM is a semi-structured interview guide for establishing a subject's activity performance levels within self-care, leisure, and productivity. The subject will set a minimum of 5 activity goals, providing a self-rating of 1-10 for level of performance. A higher score indicates a better outcome. An average self-rating score across all 5 activity goals for performance will be used in analysis
Change in baseline to follow-up average performance score (12 weeks after post-intervention assessment)
The Life Space Questionnaire
Time Frame: Change in baseline to follow-up (12 weeks after post-intervention assessment)
The Life Space Questionnaire is a self-reported measure of community mobility and social participation. It is comprised of 9 yes/no questions related to places visited in the previous three days. Total number of "yes" responses (range 0-9) will be used in the analysis. A higher score indicates better performance.
Change in baseline to follow-up (12 weeks after post-intervention assessment)
Fugl-Meyer-Upper Extremity
Time Frame: Change in baseline to follow-up (12 weeks after post-intervention assessment)
The Fugl-Meyer is a well-established measure of upper extremity motor performance in individuals with post-stroke hemiparesis. Each item is scored either a 0 (cannot perform), 1 (performs partially), or 2 (performs fully) with a maximum score of 66. Total range for each item is 0-66. A higher score indicates better performance. In the present study, the upper extremity item will be used in analysis. Only the change score is reported/analyzed. A higher change score represents more improvement on the measure.
Change in baseline to follow-up (12 weeks after post-intervention assessment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire (PHQ-9)
Time Frame: Change in baseline to follow-up (12 weeks after post-intervention assessment)
The PHQ-9 is a self-report measure of depressive symptoms. The subject identifies how often over the previous 2 weeks they have experienced 9 depressive symptoms. The total score reflects the severity of depressive symptoms. A score of 21 or greater indicates severe depressive symptoms and the total range for the measure is 0-27. A higher score indicating more depressive symptoms. The change in total score will be used in analysis. A negative change score means and improvement in depressive symptoms
Change in baseline to follow-up (12 weeks after post-intervention assessment)
NIH Toolbox (NIH-TB)-Cognition Battery
Time Frame: Change in baseline to follow-up (12 weeks after post-intervention assessment)
The NIH-TB will be used to evaluate subjects' crystallized intelligence. In contrast to the primary outcome of fluid intelligence, crystalized intelligence is more dependent upon previous learning experience. A crystalized intelligence composite T-score will be used in analysis. A T score of 50 indicates the population mean with a standard deviation of 10. A higher T score indicates better performance (less impairment). Only the change in T score reported. A higher positive T score indicates more improvement in crystallized intelligence.
Change in baseline to follow-up (12 weeks after post-intervention assessment)
Stroke Impact Scale (SIS)
Time Frame: Change in baseline to follow-up (12 weeks after post-intervention assessment) on the participation overall recovery score
The SIS is a self-report measure of stroke recovery. Specifically, the measure assesses physical, cognitive, psychosocial, community mobility, and general activity performance on a 5 point Likert scale. There is an additional item for overall recovery rated on a scale of 0 (no recovery) to 100 (full recovery). Only the overall recovery score was used in analysis. The change in overall recovery was analyzed and reported. A higher positive change in overall recovery score indicates greater improved change in perceived recovery.
Change in baseline to follow-up (12 weeks after post-intervention assessment) on the participation overall recovery score
Patient-Reported Outcomes Measurement Information System (PROMIS): Satisfaction With Social Roles and Activities (Item Bank v2.0).
Time Frame: Change in baseline to follow-up (12 weeks after post-intervention assessment)
The PROMIS Satisfaction with Social Roles and Activities item bank assesses satisfaction with performing one's usual social roles and activities. The T-score for this assessment will be used in the analysis. A T score of 50 indicates the population mean with a standard deviation of 10. A higher T score indicates higher satisfaction. Only the change in T score reported. A higher positive T score indicates more improvement in satisfaction with social roles and activities.
Change in baseline to follow-up (12 weeks after post-intervention assessment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Missouri-Columbia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Michigan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Timothy J Wolf, OTD, PhD, University of Missouri-Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 21, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 12, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 12, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 19, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2015868
  • R01HD097283 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All de-identified clinical outcome assessment data with accompanying key will be deposited in MOspace Institutional Repository, the University of Missouri's digital institutional repository. MOspace is based on MIT's DSpace technology and is a joint venture of the University of Missouri's Division of Information Technology and the University Libraries. MOspace items will include appropriate metadata and a permanent URL. Items will be freely available via the MOspace web site and will be searchable via Google and other search engines.

IPD Sharing Time Frame

After completion of study and publication of primary results manuscript. The data will be available indefinitely.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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