Effects of Training with a Powered Exoskeleton on Cortical Activity Modulation in Hemiparetic Chronic Stroke Patients: A Randomized Controlled Pilot Trial.

ABSTRACT

OBJECTIVES: To investigate the effects of exoskeleton-assisted gait training in stroke patients. DESIGN: Prospective randomized controlled trial. SETTING: Rehabilitation department in a single tertiary hospital. PARTICIPANTS: Thirty (N=30) chronic stroke patients with Functional Ambulatory Category scale (FAC) between 2 and 4. INTERVENTION Patients were randomly assigned to 1 of 2 groups training with Healbot G, a wearable powered exoskeleton (Healbot G group; n=15), or treadmill training (control group; n=15). All participants received 30 minutes of training, 10 times per week, for 4 weeks. OUTCOME MEASUREMENTS The primary outcome was oxyhemoglobin level changes, representing cortical activity in both motor cortices using functional near-infrared spectroscopy. The secondary outcomes included FAC, Berg Balance Scale, Motricity Index for the lower extremities (MI-Lower), 10-meter walk test, and gait symmetry ratio (spatial step and temporal symmetry ratio). RESULTS: Compared to the control group, during the entire training session, the pre-training and post-training mean cortical activity, and the amount of increment between pre- and post-training were significantly higher in the Healbot G group (∆mean ± SD; pre-training, 0.245±0.119, post-training, 0.697±0.429, between pre- and post-training, 0.471±0.401µmol, P<.001). There was no significant difference in cortical activity between affected- and unaffected hemispheres after Healbot G training. FAC (∆mean ± SD; 0.35 ± 0.50, P=.012), MI-Lower (∆mean ± SD; 7.01 ± 0.14, P=.001), and spatial step gait symmetry ratio (∆mean ± SD; -0.32 ± 0.25, P=.049) were improved significantly in the Healbot G group. CONCLUSION: Exoskeleton-assisted gait training induces cortical modulation effect in both motor cortices, a balanced cortical activation pattern with improvements in spatial step symmetry ratio, walking ability, and voluntary strength.