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.