Efficacy of Knee-Ankle-Foot Orthosis on Functional Mobility and Activities of Daily Living in Patients with Stroke: A Systematic Review of Case Reports.

All 14 included articles were in Japanese, limiting generalisability and independent verification. Case reports are the lowest level of evidence: there is no control group, no randomisation, and cause-and-effect cannot be established. Seven of 15 cases did not have severe flaccid motor paralysis, and 4 of 15 did not have severe sensory loss, so the sample skews toward milder presentations. Nine of 15 patients converted to an AFO after the KAFO period, meaning the KAFO was a temporary step and the long-term effect of the KAFO itself is unclear. No patient-reported outcomes (satisfaction, comfort, perceived benefit) were reported in any of the 14 articles. No adverse events were reported, but this is an absence of reporting rather than evidence of safety. Publication bias is acknowledged by the authors: only successful cases are likely to be published. Two cases in the sample were teenagers, despite the stated inclusion criterion of 18 years or older. The total sample is 15 cases, which is too small for any statistical inference.

Do not read the 10-of-15 improvement rate as proof that KAFO causes functional gains. The cases are uncontrolled, all in Japanese, 9 of the 15 patients converted to an AFO after the KAFO period, and the authors state the evidence is insufficient to draw a definite conclusion.