Background: Overground Robot-Assisted Gait Training (o-RAGT) provides intensive gait rehabilitation. This study investigated the efficacy of o-RAGT in subacute stroke subjects, compared to conventional gait training. Methods: A multicenter randomized controlled trial was conducted on 75 subacute stroke subjects (38 in the Experimental Group (EG) and 37 in the Control Group (CG)). Both groups received 15 sessions of gait training (5 sessions/week for 60 min) and daily conventional rehabilitation. The subjects were assessed at the beginning (T1) and end (T2) of the training period with the primary outcome of a 6 Minutes Walking Test (6MWT), the Modified Ashworth Scale of the Affected lower Limb (MAS-AL), the Motricity Index of the Affected lower Limb (MI-AL), the Trunk Control Test (TCT), Functional Ambulation Classification (FAC), a 10 Meters Walking Test (10MWT), the modified Barthel Index (mBI), and the Walking Handicap Scale (WHS). Results: The 6MWT increased in both groups, which was confirmed by both frequentist and Bayesian analyses. Similar outcomes were registered in the MI-AL, 10MWT, mBI, and MAS-AL. The FAC and WHS showed a significant number of subjects improving in functional and community ambulation in both groups at T2. Conclusions: The clinical effects of o-RAGT were similar to conventional gait training in subacute stroke subjects. The results obtained in this study are encouraging and suggest future clinical trials on the topic.

Upper limb recovery is one of the main goals of post-stroke rehabilitation due to its importance for autonomy in Activities of Daily Living (ADL). Although the efficacy of upper limb Robot-assisted Therapy (RT) is well established in literature, the impact of the initial status of the patient on the effects of RT is still understudied. This paper aims to identify whether demographic, clinical and motor characteristics of stroke patients may influence the ability to independently perform ADL after RT. A retrospective study was conducted on sixty stroke patients who conducted planar upper limb goal-directed tasks with the InMotion 2.0 robot. The RT was administered 5 days/week for 4 weeks and each session lasted 45 minutes. The primary outcome measure was the Modified Barthel Index (BI), dichotomized into favourable (BI ≥75) and unfavourable (BI<75) outcomes. The potential predictors were the demographic and clinical records, and the following clinical assessment scores: Modified Ashworth Scale-Shoulder (MAS-S); Modified Ashworth Scale-Elbow (MAS-E); Fugl-Meyer Assessment Upper Extremity (FMA-UE); upper limb section of the Motricity Index (MIul); total passive Range Of Motion (pROM); and Box and Block Test (BBT). Statistical analysis showed that the BBT, FMA-UE and MIul scores were significant predictors of a favourable outcome in ADL. The cut-off scores of the independent variables were calculated (FMA-UE = 32; MIul = 48; BBT = 3) with respect to the dichotomic BI outcome. Their robustness was assessed with the Fragility Index (FMA-UE = 2; MIul = 3; BBT = 7), showing that BBT is the most robust predictor of favourable BI outcome. Moreover, subjects with all predictors higher than the cut-off scores had higher probability to increase their independence in ADL at the end of the therapy. Demographic records, spasticity and pROM were not identified as predictors. Stroke patients with greater manual dexterity and less impairment appear to have a higher probability of achieving clinically significant ADL outcomes after upper limb RT. The obtained results can help to optimise the management of RT treatment planning. Further studies on a larger number of patients with a long-term follow up are recommended in order to evaluate other potential predictors and to validate the results.

Wearable powered exoskeletons provide intensive overground gait training with patient's active participation: these features promote a successful active motor relearning of ambulation in stroke survivors. The aim of this study was to investigate the feasibility and the clinical effects of an overground exoskeleton-assisted gait training (OEAGT) in subacute stroke patients. Prospective, pilot pre-post, open label, non-randomized experimental study. Four Italian neurological rehabilitation centers. Forty-eight subacute stroke patients were enrolled. Two patients dropped out because of medical problems. Data analysis was conducted on 46 subjects (56.84±14.29 years; 27 male; 29 ischemic; 24 left hemiparesis). Patients underwent 15±2 sessions (60 min/session, 3-5 times/week) of OEAGT. Clinical and gait assessments were performed at the beginning (T1) and at the end (T2) of the training period: modified Barthel Index (BI), modified Ashworth Scale at Hip (MAS-H), Knee (MAS-K), and Ankle (MAS-A) level, Motricity Index (MI), Trunk Control Test (TCT), Functional Ambulation Classification (FAC), Walking Handicap Scale (WHS), 10-Meter Walking Test (10MWT), 6-Minute Walking Test (6mWT), Timed Up-and-Go test (TUG). The Technology Acceptance Model (TAM) questionnaire evaluated the acceptance of OEAGT by patients. Data stratification was performed using the time post the acute event and the onset of rehabilitation treatment, and the MI at T1. Wilcoxon's test (P<0.05) was used. All clinical scales significantly improved at T2; no statistically significant changes were reported for MAS-H, MAS-K, MAS-A. The 69.57% patients were able to walk at T1; 17.39% were not able to walk at T1 but regained ambulation at T2; and 13.04% were not able to walk at either T1 or T2. The ambulant patients showed a statistical improvement in speed measured during the 10MWT and in the distance covered over a time of 6 minutes (6mWT). The results from the TAM questionnaire showed that all subjects perceived the OEAGT positively. The data stratification analysis suggests that the OEAGT does not have any restriction of use. The OEAGT improved the clinical and gait outcomes in subacute patients. Randomized studies on larger samples are needed to confirm these data and to assess the efficacy of OEAGT. Introduce innovative rehabilitation strategies based on customized OEAGT.