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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in baseline to follow-up (12 weeks after post-intervention assessment)
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am between 40 and 85 years old.
Select...
I can speak and understand others without significant difficulty.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change in baseline to follow-up (12 weeks after post-intervention assessment)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in baseline to follow-up (12 weeks after post-intervention assessment)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Canadian Occupational Performance Measure (COPM)
Performance Quality Rating Scale (PQRS)
The Life Space Questionnaire
+1 moreSecondary outcome measures
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 moreTrial 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
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Who is running the clinical trial?
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,965 Previous Clinical Trials
2,672,689 Total Patients Enrolled
79 Trials studying Stroke
5,279 Patients Enrolled for Stroke
University of MichiganOTHER
1,797 Previous Clinical Trials
6,377,950 Total Patients Enrolled
27 Trials studying Stroke
22,886 Patients Enrolled for Stroke
University of Missouri-ColumbiaLead Sponsor
362 Previous Clinical Trials
628,006 Total Patients Enrolled
7 Trials studying Stroke
321 Patients Enrolled for Stroke
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My stroke happened less than 9 months ago.I have set personal activity goals with the COPM.I am between 40 and 85 years old.You are unable to recognize problems with your ability to do daily activities, as shown by a specific test called the COPM.I can speak and understand others without significant difficulty.I live at home, with or without help.I have been diagnosed with dementia based on my MoCA score.I cannot move my arm due to my condition.I have mild to moderate weakness in my arm.I have severe depression, as shown by my high score on a health questionnaire.I have finished any recommended inpatient rehab.My medical records show I have a brain-related diagnosis.The principal investigator believes that participating in this study might be risky for you due to another health condition.I have mild to moderate weakness in my arm.I have set personal activity goals with the COPM.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care Occupational Therapy-Outpatient
- Group 2: Cognitive Orientation to daily Occupational Performance
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals that are older than twenty eligible to partake in this investigation?
"This research is open to participants aged 50-85."
Answered by AI
Are there any openings left to participate in this clinical experiment?
"As evidenced by clinicaltrials.gov, this trial is currently recruiting participants. It was first unveiled on November 21st 2019 and the most recent update occurred on May 5th 2022."
Answered by AI
Has the FDA authorized Cognitive Orientation to daily Occupational Performance?
"The safety of Cognitive Orientation to daily Occupational Performance has been rated a 2, as it is in Phase 2 testing and the data thus far supports safety but not efficacy."
Answered by AI
How many participants are currently engaged in this medical experiment?
"Affirmative. The information hosted on clinicaltrials.gov verifies that this medical trial is currently looking for participants, having been first published on November 21st 2019 and most recently updated on May 5th 2022. 135 patients need to be recruited from 1 site."
Answered by AI
What is the ultimate objective of this research endeavor?
"This trial aims to assess primary outcomes with the Canadian Occupational Performance Measure (COPM) over a 12-week period. Secondary endpoints include crystalized and fluid intelligence T-scores from the NIH Toolbox Cognition Battery, domain scores from the Stroke Impact Scale (SIS), and Patient Reported Outcomes Measurement Information System's Satisfaction with Social Roles and Activities item bank v2.0."
Answered by AI
Who is eligible to participate in this research trial?
"To gain admittance to this medical trial, individuals must have experienced a stroke and be between the ages of 50-85. A total of 135 people will be selected for enrolment."
Answered by AI
Who else is applying?
What site did they apply to?
University of Missouri: Department of Occupational Therapy
What portion of applicants met pre-screening criteria?
Met criteria
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