Abstract
Background:Robot-assisted gait training (RAGT) is a practical treatment adjunctive to conventional rehabilitation to provide high-intensity repetitive training for patients with stroke. The robot models designed are usually either the end-effector type or the exoskeleton type. We developed a novel hybrid RAGT system that combines the advantages of both types.Objective:This randomized controlled trial (RCT) evaluated whether the novel RAGT system was beneficial and assessed long-term effects (at the 3-month follow-up) for nonambulatory patients with subacute stroke.Methods:This trial recruited 40 patients with subacute stroke who were equally randomized to receive conventional rehabilitation or 15 add-on RAGT sessions. We assessed lower-extremity motor function, balance, and gait performance by using the following tools: active range of motion (AROM), manual muscle test (MMT), the Fugl-Meyer Assessment (FMA) lower-extremity subscale (FMA-LE) and total (FMA-total), Postural Assessment Scale for Stroke (PASS), Berg Balance Scale (BBS), Tinetti Performance Oriented Mobility Assessment (POMA) balance and gait subscores, and the 3- and 6-m walking speed and Timed Up and Go (TUG) tests. These measurements were performed before and after the intervention and at the 3-month follow-up.Results:Both groups demonstrated significant within-group changes in the AROM, MMT, FMA-LE, FMA-total, PASS, BBS, POMA, TUG, and 3- and 6-m walking speeds before and after intervention and at the 3-month follow-up (p < 0.05). Only FMA-LE (p = 0.014) and total (p = 0.002) scores differed significantly between groups (RAGT vs. control).Conclusion:Although the novel hybrid RAGT was beneficial, no powerful evidence to supported its effectiveness relative to the control group in substantial leg dysfunction after stroke.Trial Registration: The study was registered with an International Standard Randomized Controlled Trial Number, ISRCTN, ISRCTN15088682. Registered 16 September 2016, Retrospectively registered https://www.isrctn.com/ISRCTN15088682
Robot-assisted gait training for balance and lower extremity function in patients with infratentorial stroke: a single-blinded randomized controlled trial
