Effects of adding R-BoT + plus verticalization-based robotic locomotor training to conventional rehabilitation in patients with subacute stroke: a randomized controlled trial.

The experimental group received extra therapy time, so the improvement may reflect more rehabilitation rather than the R-BoT + plus device itself. Only 20 of the 23 randomized experimental participants and 23 of the 26 randomized control participants completed post-intervention analysis. The study stopped at 49 randomized participants before the planned target of 52, and the sample was small for secondary outcomes. Participants and treating therapists could not be blinded, which may have affected engagement or performance. Missing outcome data were not imputed and strict intention-to-treat analysis was not performed. The sample had severe gait impairment at baseline, with most FAC scores 0 or 1, so results may not apply to patients who already walk with little assistance. The study was single-center, and cost, resource use, and long-term applicability were not evaluated. Robotic training dose parameters such as total step count or cadence were not systematically recorded.

The Korea Health Industry Development Institute funded the study as part of the User-Based Evaluation Support Program for Domestic Medical Devices, 2024-2025. No author conflict-of-interest declaration is provided.

Do not conclude that the robotic device alone caused the improvement. The experimental group received conventional physiotherapy, occupational therapy, R-BoT + plus verticalization-based stepping, functional electrical stimulation when indicated, and virtual visual feedback, so the added therapy dose cannot be separated from the device.