Effect of the Kickstart exoskeleton lower extremity walking system on improving lower extremity walking ability in subacute stroke patients: a randomized controlled trial.

Background: Walking dysfunction is a primary cause of a reduced ability to perform activities of daily living and decreased quality of life in stroke patients. The Kickstart Walk assist system is portable and easy to don and remove. There is a lack of high-quality, randomized controlled trials to validate its effectiveness. The aim of this study was to evaluate the effectiveness of the Kickstart Walk Assist system in improving lower limb muscle strength and walking ability in stroke patients.

Methods: Forty-six patients were enrolled and randomly assigned to either a control group (n = 23) or a Kickstart group (n = 23). Both groups received conventional rehabilitation therapy. In addition, patients in the Kickstart group wore the Kickstart Walk Assist system for 20 min, and patients in the control group received walking training for 20 min. The outcome measures included the Fugl-Meyer Assessment of Lower Extremity Motor Function (FMA-LE), gait parameters, the 10MWT, the Borg Subjective Fatigue Scale (Borg), and surface electromyography (sEMG).

Results: Compared with the control group, the Kickstart group showed more significant improvements in FMA-LE at 4 and 8 weeks (P = 0.025, P = 0.028), 10-MWT (P = 0.256), Borg at 8 weeks (P = 0.035), sEMG (P < 0.05), and gait parameters (P > 0.05). No adverse events were observed during or after the intervention.

Conclusion: The Kickstart Walk assist system can increase stroke patients' lower limb strength and motor function and improve their walking ability.

Trial Registration: This study was registered in the Chinese Clinical Trial Registry (Unique Identifier ChiCTR2300067605) on January 13, 2023.