Trial results for a study investigating Metacognitive-Strategy Training in sub-acute stroke patients were posted on ClinicalTrials.gov on 2025-07-28, with 72 participants enrolled.
Background
Stroke rehabilitation often focuses on remediating post-stroke impairments, with an assumption that reducing impairments will automatically lead to improvements in activity performance. However, contemporary stroke rehabilitation, particularly task-specific training (TST), has shown limited improvement in upper extremity motor function, sometimes comparable to or less than control conditions. The long-term goal of this research was to explore alternative approaches to improve activity performance and reduce motor impairment in individuals who have experienced a stroke.
Trial design
This completed study, designated as Phase NA, enrolled 72 participants with Stroke. The trial compared two groups: "Usual Care Occupational Therapy-Outpatient" and "Cognitive Orientation to Daily Occupational Performance," which represents the metacognitive-strategy training intervention. The study aimed to assess various functional and health-related outcomes.
Key results
The trial reported several key measurements across both intervention groups:
- Canadian Occupational Performance Measure (COPM) (score on a scale):
- Usual Care Occupational Therapy-Outpatient: Mean of 3.77 (Standard Deviation 1.79)
- Cognitive Orientation to Daily Occupational Performance: Mean of 3.87 (Standard Deviation 2.52)
- Performance Quality Rating Scale (PQRS) (score on a scale):
- Usual Care Occupational Therapy-Outpatient: Mean of .069 (Standard Deviation .086)
- Cognitive Orientation to Daily Occupational Performance: Mean of .92 (Standard Deviation .93)
- The Life Space Questionnaire (score on a scale):
- Usual Care Occupational Therapy-Outpatient: Mean of -.50 (Standard Deviation 1.37)
- Cognitive Orientation to Daily Occupational Performance: Mean of -.05 (Standard Deviation .91)
- Fugl-Meyer-Upper Extremity (score on a scale):
- Usual Care Occupational Therapy-Outpatient: Mean of 1.09 (Standard Deviation 5.97)
- Cognitive Orientation to Daily Occupational Performance: Mean of 3.68 (Standard Deviation 7.3)
- Patient Health Questionnaire (PHQ-9) (score on a scale):
- Usual Care Occupational Therapy-Outpatient: Mean of -2 (Standard Deviation 6.94)
- Cognitive Orientation to Daily Occupational Performance: Mean of -2.5 (Standard Deviation 4.41)
- NIH Toolbox (NIH-TB)-Cognition Battery (score on a scale):
- Usual Care Occupational Therapy-Outpatient: Mean of 3.63 (Standard Deviation 5.04)
- Cognitive Orientation to Daily Occupational Performance: Mean of 3.93 (Standard Deviation 3.25)
Key analyses using the Wilcoxon (Mann-Whitney) method showed the following p-values, indicating no statistically significant differences between the groups for the measured outcomes: 0.693, 0.536, 0.26, 0.387, 0.826, and 0.826.
What this means
The posted trial results indicate that the Cognitive Orientation to Daily Occupational Performance intervention did not demonstrate a statistically significant advantage over usual care occupational therapy in sub-acute stroke patients across the measured outcomes. While the study provides detailed mean scores and standard deviations for various functional, cognitive, and health-related assessments, the analyses suggest comparable effects between the two approaches. These findings contribute to the understanding of rehabilitation strategies for stroke, suggesting that further research may be needed to identify interventions that yield superior outcomes in this population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04099511, titled "Metacognitive-Strategy Training in Sub-Acute Stroke", were posted on 2025-07-28 on clinicaltrials.gov.