2025 年 24 巻 2 号 p. 37-49
Gait disturbances due to hemiplegia after stroke reduce healthy life expectancy. Rehabilitation treatment guidelines in various countries recommend the use of lower limb orthoses for hemiplegia patients. Although objective outcomes such as motor function have been used to evaluate orthosis effectiveness, subjective patient-reported outcomes from orthotic users are increasingly being studied. Although patient-reported outcomes directly reflect patient health status, and tools have recently been developed to measure orthotic satisfaction, evidence on orthotic effectiveness remains limited. We conducted a scoping review to clarify the usefulness of patient-reported outcomes in evaluating the effectiveness of lower limb orthotic therapy for post-stroke hemiplegia patients. The review showed that patient-reported outcome evaluation studies on lower limb orthoses after stroke are mainly conducted in Europe, the USA, and Asia. Randomized controlled trials are frequently conducted in the USA and Europe, whereas observational studies are more common in Asia. The Quebec User Evaluation of Satisfaction with Assistive Technology 2.0 is the most frequently used patient-reported outcome measure and was found to be useful for both primary and secondary outcomes. However, owing to the limited number of studies, comprehensive evidence on the usefulness of patient-reported outcome evaluations remains lacking. Future research should focus on the international standardization and multilingual adaptation of such evaluations.