Outcome Measure Frequency in Stroke Rehabilitation Lower Extremity Randomized Controlled Trials and Its Correlation With Research and Clinical Practice Recommendations.

OBJECTIVE

To (1) determine the frequency of outcome measures (OMs) used in randomized controlled trials (RCTs) of lower extremity (LE) rehabilitation after stroke; (2) to categorize OMs based on the International Classification of Functioning, Disability, and Health (ICF) framework; and to (3) determine how use of OMs correlates with current research and clinical practice recommendations.

DATA SOURCES: Systematic searches were conducted in Embase, CINAHL, MEDLINE, and PsycINFO, up to December 2024, in line with Preferred Reporting Items for Systematic Reviews and Meta Analyses guidelines.

STUDY SELECTION: RCTs published in English were included if they evaluated a rehabilitation intervention for LE motor dysfunction in adults (≥18y).

DATA EXTRACTION: Two independent reviewers screened titles and abstract and conducted a full-text review against the inclusion criteria. Covidence was used for article screening and data extraction.

DATA SYNTHESIS: A total of 1548 RCTs were included, with 339 unique OMs identified and classified according to the ICF: body structures and function (n=112), activities (n=161), and participation (n=66). The most frequently used OMs were the Berg Balance Scale (31.5%), Biomechanical Gait Measures (29.3%), 10-Metre Walk Test (28.2%), timed Up and Go test (25.5%), Fugl-Meyer Assessment (23.1%), 6-Minute Walk Test (18.6%), Gait Speed (15.4%), Barthel Index (14.1%), Functional Ambulation Category (12.0%), and the Modified Ashworth Scale (11.5%). To a certain degree, OM utilization aligns with current recommendations, given that the Fugl-Meyer Assessment was recommended in 10 of 12 guidelines, and the Berg Balance Scale in 8 of 12 guidelines; in contrast, some OMs are included in guideline recommendations but are used in very few RCTs.

CONCLUSIONS

Despite recommendations to streamline OMs used in LE stroke rehabilitation studies, including those available in the last decade, OM utilization in RCTs shows significant heterogeneity, which may limit meaningful comparisons of interventions.