Effects of Electromechanical Exoskeleton-Assisted Gait Training on Walking Ability of Stroke Patients: A Randomized Controlled Trial.

OBJECTIVE: To assess the efficacy of electromechanical exoskeleton-assisted gait training on walking ability of stroke patients based on ambulatory function, muscle strength, balance, gait speed, and capacity. DESIGN: Randomized controlled trial. SETTING: University rehabilitation hospital. PARTICIPANTS: Individuals (N=40) with stroke who could stand alone. INTERVENTIONS: Patients were randomly assigned to control and experimental groups. The control group underwent physical therapist-assisted gait training by conventional method. The experimental group underwent electromechanical gait training assisted by an exoskeleton device. Both types of gait training were performed for 30 minutes each day. The therapeutic interventions were provided for 5 days a week for a period of 4 weeks in both groups. MAIN OUTCOME MEASURES: Functional ambulatory category (FAC) before and after gait training. Changes in FAC were the primary outcomes to evaluate the efficacy of electromechanical exoskeleton-assisted gait training. Changes in mobility, walking speed, walking capacity, leg muscle strength, daily activity, and balance were secondary outcomes. RESULTS: FAC in the control group was 2.44±1.55 in the pretraining and 2.75±1.53 in the post-training. FAC in the experimental group was 3.22±1.31 in the pretraining and 3.78±1.44 in the post-training. Although FAC between pre- and post-training sessions improved in both groups, the changes in FAC were statistically significant in the experimental group alone. Most secondary outcomes in both groups also showed improvement after gait training. However, the differential outcomes were not varied between the 2 groups after adjusting the data for age and stroke duration. We did not exclude patients based on time since stroke onset. The average stroke duration was 530.11±389.21 days in the experimental group. The changes in FAC of the experimental group were negatively correlated with stroke duration. No adverse events were noticed during gait training in either group. CONCLUSIONS: Electromechanical exoskeleton-assisted gait training is as effective as conventional gait training by a physical therapist when administered by a gait trainer. As an overground walking system without harness, electromechanical exoskeleton replaced a physical therapist in assisted gait training for patients who stand alone. Because the ambulatory function of stroke patients was affected negatively by stroke duration, the effect of electromechanical-assisted gait training might decline with increased stroke duration.