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NCT04099511 · ClinicalTrials.gov registry record · NA
Metacognitive-Strategy Training in Sub-Acute Stroke
A NA study, sponsored by University of Missouri-Columbia.
- Completed
- Registry status
- NA
- Development phase
- 72
- Enrollment target
NCT04099511: Completed NA study, sponsored by University of Missouri-Columbia.
NCT04099511 is a NA study that has completed, run by University of Missouri-Columbia. The registered enrollment target is 72 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04099511, a NA study, has completed, sponsored by University of Missouri-Columbia.
- COMPLETED
- Registry status
- NA
- Development phase
- 72 participants
- Enrollment target
Study 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 sp
Primary Outcome
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
Interventions
- BEHAVIORAL Usual Care Occupational Therapy-Outpatient
- BEHAVIORAL Cognitive Orientation to daily Occupational Performance
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2019-11-21 |
| Est. Completion | 2024-09-12 |
| Phase | NA |
What the finished NCT04099511 record still lists
NCT04099511 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Usual Care Occupational Therapy-Outpatient is the first listed.
NCT04099511 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04099511 about?
NCT04099511 is a clinical study titled "Metacognitive-Strategy Training 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 improve...
What is the current status of trial NCT04099511?
This trial is currently completed. It is a NA study. The enrollment target is 72 participants. The study started on 2019-11-21. Estimated completion is 2024-09-12.
What interventions are being tested in trial NCT04099511?
The interventions under investigation include: Usual Care Occupational Therapy-Outpatient (BEHAVIORAL), Cognitive Orientation to daily Occupational Performance (BEHAVIORAL).
Who is sponsoring clinical trial NCT04099511?
This trial is sponsored by University of Missouri-Columbia, which has 291 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04099511's enrollment target sits among peer trials
72 1089th of 2000 higher than 899 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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