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Effects of robot (SUBAR)-assisted gait training in patients with chronic stroke: randomized controlled trial
Kang CJ, Chun MH, Lee J, Lee JY
Medicine 2021 Dec 3;100(48):e27974
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; 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*

BACKGROUND: SUBAR is a new ground walking exoskeletal robot. The objective of this study is to investigate SUBAR-assisted gait training's effects in patients with chronic stroke. METHODS: This preliminary study is a prospective randomized controlled trial. Thirty adults were enrolled 6 months after the onset of stroke with functional ambulation category scores >= 3. Patients were randomly assigned to receive robot-assisted gait training (SUBAR group, n = 15) or conventional physiotherapy (control group, n = 15). All patients received a total of 10 treatment sessions of 30 minutes each for 3 weeks. Before and after the 10-treatment sessions, patients were evaluated. The primary outcome is the 10 meter walk test and the secondary outcomes were the functional ambulation category scale, the Motricity Index-Lower, Modified Ashworth Scale (MAS), Timed Up and Go, Rivermead Mobility Index, Berg Balance Scale (BBS), and gait analysis. RESULTS: In the SUBAR group, MAS and step length were significantly improved between pre- and posttreatment measurements (delta mean +/- SD -1.1 +/- 1.6 and 5.5 +/- 7.6, p = 0.019 and 0.016, respectively). The SUBAR group improved the stride length and step length of the affected limb but not significantly. The control group had significant improvements in the BBS, MAS, and stride length between pre- and posttreatment measurements (delta mean +/- SD 3.5 +/- 4.6, -0.8 +/- 1.5, and 6.5 +/- 9.5; p = 0.004, 0.031, and 0.035, respectively). The BBS improved more in the control group than in the SUBAR group. There were no other differences between the SUBAR group and the control group. CONCLUSION: Our results suggest that SUBAR-assisted gait training improved gait parameters in patients with chronic stroke. However, there was no significant difference in most outcome measures compared to conventional physiotherapy. Further research is warranted to measure the effects of SUBAR-assisted gait training.

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