Background: The loss of arm function is a common and disabling outcome after stroke. Robot-assisted upper limb (UL) training may improve outcomes. The aim of this study was to explore the effect of robot-assisted training using end-effector and exoskeleton robots on UL function following a stroke in real-life clinical practice. Methods: A total of 105 patients affected by a first-ever supratentorial stroke were enrolled in 18 neurorehabilitation centers and treated with electromechanically assisted arm training as an add-on to conventional therapy. Both interventions provided either an exoskeleton or an end-effector device (as per clinical practice) and consisted of 20 sessions (3/5 times per week; 6–8 weeks). Patients were assessed by validated UL scales at baseline (T0), post-treatment (T1), and at three-month follow-up (T2). The primary outcome was the Fugl-Meyer Assessment for the upper extremity (FMA-UE). Results: FMA-UE improved at T1 by 6 points on average in the end-effector group and 11 points on average in the exoskeleton group (p < 0.0001). Exoskeletons were more effective in the subacute phase, whereas the end-effectors were more effective in the chronic phase (p < 0.0001). Conclusions: robot-assisted training might help improve UL function in stroke patients as an add-on treatment in both subacute and chronic stages. Pragmatic and highmethodological studies are needed to confirm the showed effectiveness of the exoskeleton and end-effector devices.

Background: The efficacy of upper limb (UL) robot-assisted therapy (RAT) on functional improvement after stroke remains unclear. However, recently published randomized controlled trials have supported its potential benefits in enhancing the activities of daily living, arm and hand function, and muscle strength. Task-specific and high-intensity exercises are key points in facilitating motor re-learning in neurorehabilitation since RAT can provide an assisted-as-needed approach. This study aims to investigate the clinical effects of an exoskeleton robotic system for UL rehabilitation compared with conventional therapy (CT) in people with subacute stroke. As a secondary aim, we seek to identify patients’ characteristics, which can predict better recovery after UL-RAT and detects whether it could elicit greater brain stimulation. Methods: A total of 84 subacute stroke patients will be recruited from 7 Italian rehabilitation centers over 3 years. The patients will be randomly allocated to either CT (control group, CG) or CT plus UL-RT through an Armeo^®Power (Hocoma AG, CH, Volketswil, Switzerland) exoskeleton (experimental group, EG). A sample stratification based on distance since onset, DSO (DSO ≤ 30; DSO > 30), and Fugl–Meyer Assessment (FM)-UL (FM-UL ≤ 22; 22 < FM-UL ≤ 44) will be considered for the randomization. The outcomes will be recorded at baseline (T0), after 25 + 3 sessions of intervention (T1), and at 6 months post-stroke (T2). The motor functioning assessed by the FM-UL (0–66) will be considered the primary outcome. The clinical assessments will be set based on the International Classification of Function, Disability and Health (ICF). A patient satisfaction questionnaire will be evaluated in the EG at T1. A subgroup of patients will be evaluated at T0 and T1 via electroencephalography. Their brain electrical activity will be recorded during rest conditions with their eyes closed and open (5 min each). Conclusion: The results of this trial will provide an in-depth understanding of the efficacy of early UL-RAT through a whole arm exoskeleton and how it may relate to the neural plasticity process. The trial was registered at ClinicalTrial.gov with the registration identifier NCT04697368.

BACKGROUND: Robot-assisted therapy (RAT) with exoskeletons is believed to enhance motor recovery in stroke survivors. RAT offers intensive, feedback-based, task-oriented training to improve function. This study evaluated exoskeleton-based RAT integrated into usual rehabilitation care for individuals in early subacute stroke. METHODS: This multicenter randomized controlled trial was conducted across 8 stroke neurorehabilitation units over a 3-year period (December 2020–March 2024). Inpatients with moderate-to-severe upper limb impairment postsubacute stroke (<3 months poststroke) were randomized (1:1) to 25 sessions (5/week for 5 weeks) of exoskeleton-assisted RAT (robotic group) or conventional rehabilitation (control group). Outcome assessors were blinded. The primary outcome was the change in the Fugl-Meyer Assessment for Upper Limb (motor section, 0–66) from baseline to treatment end. Secondary outcomes addressed body function, activity (capacity/performance), and participation. Clinical assessments were at baseline (T0), posttreatment (T1), and 6-month telephone follow-up (T2). Odds ratio for achieving a minimal clinically important difference (≥10 points) on the Fugl-Meyer Assessment for Upper Limb was calculated. RESULTS: A total of 109 individuals with subacute stroke were screened. Of these, 94 (35% women; mean age 62.5±13.5 years; mean onset 34±28 days) were eligible and randomized, and 82 completed the intervention (12% dropout). No significant differences were observed at baseline, despite the median Fugl-Meyer score being 16 in the robotic group and 10 in the control group. The robotic group showed significantly greater improvement in Fugl-Meyer Assessment for Upper Limb motor score than the control group, with a median between-group difference of 22 points ( P <0.001). Minimal clinically important difference was reached by 68.4% in the robotic group versus 31.8% in the control group (odds ratio, 4.64 [95% CI, 1.83–11.8]; P <0.001). All secondary outcomes improved significantly in both groups with no significant differences between groups, except for spasticity, which showed no significant change. CONCLUSIONS: Exoskeleton-assisted RAT offers significant clinical benefits in early poststroke upper limb recovery, yielding higher minimal clinically important difference rates on impairment outcomes but not on specific functional measures compared with conventional therapy. Further research should evaluate long-term effects and optimize protocols based on patient characteristics. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04697368.