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Behavioral Intervention

Metacognitive Strategy Training for Stroke

Phase 2
Recruiting
Led By Timothy J Wolf, OTD, PhD
Research Sponsored by University of Missouri-Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults age 40-85
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
Must not have
Dementia symptoms as indicated by a score of <23 on the Montreal Cognitive Assessment (MoCA)
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in baseline to follow-up (12 weeks after post-intervention assessment)
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to improve activity performance and reduce motor impairment in individuals with stroke through metacognitive strategy training.

Who is the study for?
This trial is for adults aged 40-85 who have had a stroke within the last 9 months, can read and write in English, and are living at home (with or without help). They should be able to move their arms somewhat but not fully (mild to moderate arm weakness), and they shouldn't have severe speech problems, depression, dementia, other serious neurological issues or any condition that would make the study unsafe for them.
What is being tested?
The trial tests a new way of rehab called Metacognitive Strategy Training using the CO-OP approach against usual care occupational therapy. It's designed to see if this strategy helps improve daily activities and motor function after a stroke. Participants will get either ten sessions of this new training or regular therapy, with follow-ups before treatment starts, right after it ends, and three months later.
What are the potential side effects?
Since this is an educational intervention focusing on cognitive strategies rather than medication or invasive procedures, significant side effects are not expected. However, participants may experience fatigue or frustration during rehabilitation exercises.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 40 and 85 years old.
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I can speak and understand others without significant difficulty.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with dementia based on my MoCA score.
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I cannot move my arm due to my condition.
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I have severe depression, as shown by my high score on a health questionnaire.
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My medical records show I have a brain-related diagnosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in baseline to follow-up (12 weeks after post-intervention assessment)
This trial's timeline: 3 weeks for screening, Varies for treatment, and change in baseline to follow-up (12 weeks after post-intervention assessment) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Canadian Occupational Performance Measure (COPM)
Performance Quality Rating Scale (PQRS)
The Life Space Questionnaire
+1 more
Secondary study objectives
NIH Toolbox (NIH-TB)-Cognition Battery
Patient Health Questionnaire (PHQ-9)
Patient-Reported Outcomes Measurement Information System (PROMIS): Satisfaction with Social Roles and Activities (Item Bank v2.0)
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Cognitive Orientation to daily Occupational PerformanceExperimental Treatment1 Intervention
Group II: Usual Care Occupational Therapy-OutpatientActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Orientation to daily Occupational Performance
2023
N/A
~20

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,045 Previous Clinical Trials
2,730,845 Total Patients Enrolled
83 Trials studying Stroke
5,702 Patients Enrolled for Stroke
University of MichiganOTHER
1,849 Previous Clinical Trials
6,431,412 Total Patients Enrolled
27 Trials studying Stroke
22,886 Patients Enrolled for Stroke
University of Missouri-ColumbiaLead Sponsor
377 Previous Clinical Trials
628,581 Total Patients Enrolled
8 Trials studying Stroke
421 Patients Enrolled for Stroke

Media Library

Cognitive Orientation to daily Occupational Performance (CO-OP) (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04099511 — Phase 2
Stroke Research Study Groups: Usual Care Occupational Therapy-Outpatient, Cognitive Orientation to daily Occupational Performance
Stroke Clinical Trial 2023: Cognitive Orientation to daily Occupational Performance (CO-OP) Highlights & Side Effects. Trial Name: NCT04099511 — Phase 2
Cognitive Orientation to daily Occupational Performance (CO-OP) (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04099511 — Phase 2
~2 spots leftby Dec 2024