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

Abstract

Background: Early recovery of gait and trunk control during the subacute phase after stroke is crucial for long-term functional outcomes. Robotic-assisted rehabilitation enabling upright positioning, weight-bearing, and repetitive stepping-like movements has emerged as a promising adjunct to conventional therapy. The primary aim of this study was to evaluate whether adding R-BoT + plus verticalization-based robotic locomotor training to conventional inpatient rehabilitation leads to greater improvement in gait independence than conventional rehabilitation alone. The secondary aims were to assess the effects of the intervention on trunk control, cognitive function, activities of daily living (ADL), balance, and lower-extremity motor function.

Methods: This single-center, prospective, randomized controlled trial was conducted in an inpatient rehabilitation setting and enrolled patients with subacute stroke and severe gait impairment. Participants were randomly assigned to receive either R-BoT + plus verticalization robotic locomotor training combined with conventional rehabilitation or conventional rehabilitation alone. Both groups received conventional rehabilitation five times per week for 4 weeks. The experimental group also received R-BoT + plus verticalization-based robotic locomotor training with the same frequency and duration (20 sessions; 30 min per session). Outcomes were assessed at baseline (preintervention) and postintervention, with a 3-month follow-up for gait independence.

Results: Patients who received R-BoT + plus training demonstrated significantly greater improvement in the Functional Ambulation Category than the control group. Mixed-effects modeling showed sustained benefits favoring the experimental group at postintervention and at 3-month follow-up. Although the overall change in Trunk Control Test scores did not differ significantly between groups, an exploratory baseline-adjusted robust regression suggested that patients with lower baseline trunk control experienced significantly greater post-intervention improvement in the experimental group. Other functional outcomes, including cognition, balance, ADL, and lower-extremity motor function, improved in both groups without significant between-group differences.

Conclusions: R-BoT + plus verticalization-based robotic locomotor training provides additional benefits for gait independence and trunk control when added to conventional rehabilitation in patients with subacute stroke, particularly among those with greater initial impairment.

Trial registration: This study was prospectively registered at the Clinical Research Information Service (CRiS), Republic of Korea (registration number: KCT0010040).