Metacognitive-Strategy Training in Sub-Acute Stroke

NCT ID: NCT04099511

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-21
• Study Completion Date: 2024-09-12

Brief Summary

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)

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Usual Care Occupational Therapy-Outpatient

Group Type: ACTIVE_COMPARATOR

Usual Care Occupational Therapy-Outpatient

Intervention Type: BEHAVIORAL

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.

Cognitive Orientation to daily Occupational Performance

Group Type: EXPERIMENTAL

Cognitive Orientation to daily Occupational Performance

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: collaborator

University of Missouri-Columbia

OTHER

Sponsor Role: lead

Responsible Party

Timothy J Wolf

Associate Professor and Chair

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Timothy J Wolf, OTD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

University of Missouri: Department of Occupational Therapy

Columbia, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R01HD097283

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2015868

Identifier Type: -

Identifier Source: org_study_id