The effect of the Lokomat® robotic-orthosis system on lower extremity rehabilitation in patients with stroke: a systematic review and meta-analysis

Background: The Lokomat (R) is a device utilized for gait training in post-stroke patients. Through a systematic review, the objective was to determine whether robot-assisted gait training with the Lokomat (R) is more effective in enhancing lower extremity rehabilitation in patients with stroke in comparison to conventional physical therapy (CPT).Methods: In this study, a systematic search was conducted in various databases, including CINAHL, MEDLINE, PubMed, Embase, Cochrane Library, Scopus, Web of Science, and Physiotherapy Evidence Database (PEDro), as well as bibliographies of previous meta-analyses, to identify all randomized controlled trials that investigated the use of Lokomat (R) devices in adult stroke patients. The study aimed to derive pooled estimates of standardized mean differences for six outcomes, namely, Fugl-Meyer Assessment lower-extremity subscale (FMA-LE), Berg Balance Scale (BBS), gait speed, functional ambulation category scale (FAC), timed up and go (TUG), and functional independence measure (FIM), through random effects meta-analyses.Results: The review analyzed 21 studies with a total of 709 participants and found that the use of Lokomat (R) in stroke patients resulted in favorable outcomes for the recovery of balance as measured by the BBS (mean difference = 2.71, 95% CI 1.39 to 4.03; p < 0.0001). However, the FAC showed that Lokomat (R) was less effective than the CPT group (mean difference = -0.28, 95% CI -0.45 to 0.11, P = 0.001). There were no significant differences in FMA-LE (mean difference = 1.27, 95% CI -0.88 to 3.42, P = 0.25), gait speed (mean difference = 0.02, 95% CI -0.03 to 0.07, P = 0.44), TUG (mean difference = -0.12, 95% CI -0.71 to 0.46, P = 0.68), or FIM (mean difference = 2.12, 95% CI -2.92 to 7.16, P = 0.41) between the Lokomat (R) and CPT groups for stroke patients.Conclusion: Our results indicate that, with the exception of more notable improvements in balance, robot-assisted gait training utilizing the Lokomat (R) was not superior to CPT based on the current literature. Considering its ability to reduce therapists' work intensity and burden, the way in which Lokomat (R) is applied should be strengthened, or future randomized controlled trial studies should use more sensitive assessment criteria.