Clinical trial NCT04099511: Metacognitive-Strategy Training in Sub-Acute Stroke
Official title: Efficacy of Metacognitive-Strategy Training to Improve Activity Performance and Reduce Motor Impairment in Sub-Acute Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stroke
Keywords: Stroke
Occupational therapy
Rehabilitation
Participation
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: University of Michigan
First posted: 2019-09-23
Enrollment: 72
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A single-blind, parallel, randomized clinical trial design will be used in this study. Randomization will be conducted using stratified randomization. Randomization will be stratified by age (50-68 v 69-85) and stroke severity (NIHSS total score 1-16 v \>16). Within each strata randomization will be blocked to help ensure an equal number of participants have been assigned to each intervention group.
Primary purpose: TREATMENT

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)


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

Primary outcomes:
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: Change in baseline to follow-up (12 weeks after post-intervention assessment)
measure: Performance Quality Rating Scale (PQRS)
timeFrame: Change in baseline to follow-up (12 weeks after post-intervention assessment)
measure: The Life Space Questionnaire
timeFrame: Change in baseline to follow-up (12 weeks after post-intervention assessment)
measure: Upper Extremity Fugl-Meyer
timeFrame: Change in baseline to follow-up (12 weeks after post-intervention assessment)
Secondary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Change in baseline to follow-up (12 weeks after post-intervention assessment)
measure: NIH Toolbox (NIH-TB)-Cognition Battery
timeFrame: Change in baseline to follow-up (12 weeks after post-intervention assessment)
measure: Stroke Impact Scale (SIS)
timeFrame: Change in baseline to follow-up (12 weeks after post-intervention assessment)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS): Satisfaction with Social Roles and Activities (Item Bank v2.0)
timeFrame: Change in baseline to follow-up (12 weeks after post-intervention assessment)
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri: Department of Occupational Therapy
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Timothy J Wolf, OTD, PhD
role: PRINCIPAL_INVESTIGATOR
References: