Outcome Measure Frequency in Stroke Rehabilitation Lower Extremity Randomized Controlled Trials and Its Correlation...

Area of Science:

• Neurology
• Rehabilitation Medicine
• Clinical Trials

Background:

• Stroke frequently causes lower extremity (LE) motor dysfunction.
• Standardized outcome measures (OMs) are crucial for evaluating rehabilitation interventions in randomized controlled trials (RCTs).
• The International Classification of Functioning, Disability, and Health (ICF) provides a framework for categorizing OMs.

Purpose of the Study:

• To determine the frequency of OMs used in LE post-stroke rehabilitation RCTs.
• To categorize these OMs according to the ICF framework.
• To assess the correlation between OM usage and current research/clinical practice recommendations.

Main Methods:

• Systematic literature searches were conducted across major databases (Embase, CINAHL, MEDLINE, PsycINFO) up to December 2024.
• Included were English-language RCTs evaluating LE motor rehabilitation interventions in adults.
• Data extraction and screening were performed by two independent reviewers using Covidence, adhering to PRISMA guidelines.

Main Results:

• 1,548 RCTs yielded 339 unique OMs, categorized under ICF: body structures/function (n=112), activities (n=161), and participation (n=66).
• Top OMs included Berg Balance Scale (31.5%), 10-Metre Walk Test (28.2%), and Fugl-Meyer Assessment (23.1%).
• OM utilization partially aligns with guidelines (e.g., Fugl-Meyer Assessment in 10/12 guidelines), but some recommended OMs are rarely used.

Conclusions:

• Significant heterogeneity exists in OM selection for LE stroke rehabilitation RCTs.
• This variability may impede meaningful comparisons between different rehabilitation interventions.
• Despite recommendations for standardization, heterogeneity in OMs persists, potentially limiting clinical translation.