Trial reportThe Journal of international medical research2025
Effectiveness and safety of a lower-limb walking assist device for motor function recovery in subacute stroke patients: A prospective, randomized, open, parallel-controlled, noninferiority study.
Trial report in The Journal of international medical research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
ObjectiveTo evaluate the effectiveness and safety of the MI-R1 lower-limb walking assist device for gait training in subacute stroke patients.MethodsThe experimental group received lower-limb function training using the lower-limb training device. In contrast, the control group received lower-limb function training provided by a therapist. After 4 weeks, the patients were evaluated for certain indicators. The primary outcome was the Fugl-Meyer Assessment Lower Extremity score on day 28 (±7 days). The secondary outcomes included the Functional Ambulation Category score, Modified Barthel Index score, safety indicators, and incidence of adverse events.ResultsAfter treatment, the noninferiority statistic between the experimental and control groups was -0.1976 (-1.5051, 1.1099). The lower limit of the 95% confidence interval was greater than the noninferiority margin. There was no significant difference in the Functional Ambulation Category or Modified Barthel Index scores between the experimental and control groups at 0, 14, and 28 days (
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