Current Evidence of Knee–Ankle–Foot Orthosis Therapy for Patients with Stroke: A Scoping Review

This review aims to summarize the primary aims of studies, patient characteristics, KAFO usage, reported outcome measures, and to evaluate the methodological quality and certainty of the evidence in studies regarding KAFO therapy for patients with stroke.This review aims to summarize the primary aims of studies, patient characteristics, KAFO usage, reported outcome measures, and to evaluate the methodological quality and certainty of the evidence in studies regarding KAFO therapy for patients with stroke.

A comprehensive search was conducted across seven databases—PubMed, CINAHL, Scopus, CENTRAL, PEDro, Web of Science, and Igaku Chuo Zasshi—from January 1964 to July 2024. The search targeted studies evaluating the impact of KAFO therapy on functional mobility or activities of daily living in patients with stroke. The results were presented following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR) guidelines. The primary aims of studies, patient characteristics, KAFO usage, and reported outcome measures were summarized descriptively. The methodological quality of the included studies was evaluated using the STROBE statement, and the certainty of the evidence was evaluated with the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach. The study protocol was registered in the PROSPERO International Prospective Register of Systematic Reviews (CRD42020219359).

Ten observational studies were included—seven case-control studies, two retrospective studies, and one cross-sectional study. No randomized controlled trials (RCTs) were identified. The primary aims of studies focused on three areas: comparing the efficacy of KAFO with ankle-foot orthosis (AFO), identifying the characteristics of responders, and examining the effects of early KAFO prescription. Most of the trials involved patients with acute or sub-acute stroke. None of the studies examined treatment effects based on the severity of motor paralysis. Functional independence measure (FIM) was commonly used as an outcome, while few trials reported walking ability. Serious methodological issues, such as inadequate adjustment for potential confounders and participant selection bias, were identified. The certainty of the evidence for KAFO therapy in patients with stroke was very low. 

This scoping review highlights that current research on KAFO therapy for stroke patients focuses on responder characteristics, comparisons with AFO, and the benefits of early prescription for acute to sub-acute patients. Future studies should investigate the treatment effects on walking ability according to motor paresis severity and dose-dependent effects of KAFO therapy. To improve evidence certainty, future studies must minimize selection bias and carefully account for confounding variables.

These findings provide initial insights for clinical practice in enhancing mobility in patients with stroke using KAFO and offer direction for future research to establish stronger scientific evidence.