脳卒中リハビリテーション下肢ランダム化比較試験におけるアウトカム測定頻度とその研究および臨床実践推奨事項との相関

To (1) determine the frequency of outcome measures (OMs) used in randomized controlled trials (RCTs) of lower extremity (LE) rehabilitation post-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.

Systematic searches were conducted in Embase, CINAHL, MEDLINE, and PsycINFO, up to December 2024, in line with PRISMA guidelines.

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

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

1,548 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 the Fugl-Meyer Assessment was recommended in 10 out of 12 guidelines, and the Berg Balance Scale in 8 out of 12 guidelines; in contrast, some OMs are included in guideline recommendations but are utilized in very few RCTs.

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.