Paper Proposes Improving Stroke Clinical Trial Evaluation to Prevent Misjudging Efficacy

Niigata University of Health and Welfare Professor Masato Kanazawa and Niigata University's Brain Research Institute published a brief opinion paper in Journal of Cerebral Blood Flow & Metabolism on May 28, 2026. The paper highlights why clinical trials for post-stroke motor recovery often fail to show consistent results. The team points out that promising treatments are frequently misjudged as 'ineffective' due to a mismatch between the therapeutic targets and the evaluation metrics used. Standard scales like the modified Rankin Scale (mRS) or Barthel Index (BI) measure overall disability but fail to capture specific improvements in hand movements or walking speed. To address this, the researchers recommend aligning evaluation methods with the WHO's International Classification of Functioning, Disability and Health (ICF) framework across three levels: body function, activity, and participation. Furthermore, they emphasize adopting the Minimal Clinically Important Difference (MCID) to evaluate changes that patients perceive as personally meaningful, shifting focus beyond statistical significance alone.