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Effects of training with a powered exoskeleton on cortical activity modulation in hemiparetic chronic stroke patients: a randomized controlled pilot trial [with consumer summary]
Yoo M, Chun MH, Hong GR, Lee C, Lee JK, Lee A
Archives of Physical Medicine and Rehabilitation 2023 Oct;104(10):1620-1629
clinical trial
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

To investigate the effects of exoskeleton-assisted gait training in stroke patients. Prospective randomized controlled trial. Rehabilitation department in a single tertiary hospital. Thirty (n = 30) chronic stroke patients with Functional Ambulatory Category scale (FAC) between 2 and 4. 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. 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). 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 (delta mean +/- SD; pre-training, 0.245 +/- 0.119, post-training, 0.697 +/- 0.429, between pre- and post-training, 0.471 +/- 0.401 micromol, p < 0.001). There was no significant difference in cortical activity between affected- and unaffected hemispheres after Healbot G training. FAC (delta mean +/- SD; 0.35 +/- 0.50, p = 0.012), MI-Lower (delta mean +/- SD; 7.01 +/- 0.14, p = 0.001), and spatial step gait symmetry ratio (delta mean +/- SD; -0.32 +/- 0.25, p = 0.049) were improved significantly in the Healbot G group. 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.

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