Are clinical trials of walking rehabilitation after stroke capturing community mobility and participation outcomes? A descriptive methodological review.

The growing volume of stroke rehabilitation trials underscores the need to ensure that outcome measures are aligned with patient priorities to maximize clinical relevance and minimize research waste. The objective of this review was to examine the extent to which primary outcomes used in randomized and quasi-randomized trials of post-stroke walking rehabilitation capture community mobility and participation-level constructs. This review evaluated primary outcome selection in randomized and quasi-randomized trials of walking rehabilitation after stroke. A search of PubMed, CENTRAL, and PEDro identified 593 eligible studies (2013-2023), from which a random sample of 100 trials was analyzed. Primary outcomes were classified a priori into four construct-level categories: impairment-based, performance-based walking capacity, functional walking and mobility, and community and participation-level outcomes. Performance-based walking capacity outcomes were most frequently selected as primary outcomes (39%), followed by functional walking and mobility outcomes (36%) and impairment-based outcomes (22%). Community and participation-level walking outcomes were rarely prioritized (3%). With respect to participant characteristics, most trials enrolled ambulatory participants (68%), while trials exclusively enrolling non-ambulatory participants were underrepresented (10%). These findings highlight a persistent emphasis on performance-based and impairment-level primary outcomes in stroke walking rehabilitation trials. Based on an evaluation of primary outcome selection in a randomly sampled subset of trials, this review underscores the need for systematic incorporation of participation-level outcomes that capture real-world functioning after stroke, as well as greater inclusion of non-ambulatory participants to ensure that intervention research addresses the full spectrum of walking recovery.