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End-effector lower limb robot-assisted gait training effects in subacute stroke patients: a randomized controlled pilot trial
Lee J, Kim DY, Lee SH, Kim JH, Kim DY, Lim K-B, Yoo J
Medicine 2023 Oct 20;102(42):e35568
clinical trial
5/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: No. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: This pilot study investigated end-effector lower limb rehabilitation robot training effects in subacute stroke patients. METHODS: Forty-nine stroke patients were randomly assigned to 2 treatment groups; a 30-minute end-effector lower limb rehabilitation robot training plus 1.5-hour conventional physiotherapy (robot group; n = 26), or a 2-hour conventional physiotherapy (control group; n = 23). All patients received 5 treatments weekly for 4 weeks. The functional ambulatory category was the primary outcome and the motricity index, Fugl Meyer assessment-lower extremity, rivermead mobility index, 10 meter walk test, Berg Balance Scale, and Modified Barthel Index were secondary outcomes. RESULTS: All outcome measures significantly improved in both groups after training (p > 0.05). The robot group improved more in FAC than the control group (p = 0.005). CONCLUSIONS: Compared with conventional physiotherapy alone, end-effector lower limb robot-assisted gait training with conventional physiotherapy improved subacute stroke patients walking ability.

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