Effects of semi-independent bedside rehabilitation of the upper limb assisted with a mobile wrist-hand exoneuromusculoskeleton (ENMS) for inpatients with subacute stroke: a randomized controlled trial (RCT)

Background: Robotic-assisted rehabilitation has been used to release the labor burden in manual practice for early stroke rehabilitation. However, its broader application is constrained by high costs, limited accessibility, and high dependence on professional operation. This study aimed to investigate the feasibility and effectiveness of semi-independent, bedside upper limb rehabilitation assisted by a wrist-hand exoneuromusculoskeleton (WH-ENMS) for individuals with subacute stroke via a randomized controlled trial compared with the outcomes achieved by conventional therapy and training programs assisted by an interlimb-coordinated (IC) robot. Methods: Fifty-four participants with subacute stroke were randomized into three groups: ENMS, IC, or conventional therapy. All groups underwent 21 rehabilitation sessions (60 min/day for 21 consecutive days), each including 30 min of standardized Bobath therapy. During the additional 30 min of training, the ENMS group engaged in semi-independent bedside training with minimal supervision, the IC group received supervised IC cycling, and the conventional group received proprioceptive neuromuscular facilitation. The rehabilitative effects were evaluated via clinical scores. The primary outcome was the Fugl-Meyer Assessment-Upper Extremity (FMA-UE), and the secondary outcomes included the action research arm test (ARAT), modified Ashworth scale (MAS), and modified Barthel index (MBI). The manpower consumption was quantified on the basis of the professional hours required during training. Results: The ENMS group required significantly less total occupational therapist (OT) involvement (11.6 h) compared with the IC (22.9 h) and conventional (21.0 h) groups, representing a 49.4% reduction in professional manpower demand. All groups showed significant improvements in FMA-UE, ARAT, and MBI scores. Compared with the other groups, the ENMS group achieved superior gains in voluntary motor function (FMA-UE and ARAT, P < 0.05). The ENMS group also obtained significant reductions in muscle spasticity across multiple joints (MAS, P < 0.05). The IC group demonstrated the largest MBI improvements, while the conventional group showed greater gains in hand function than the IC group (P < 0.05). Conclusions: Semi-independent bedside rehabilitation with WH-ENMS is feasible, safe, and effective for inpatients with subacute stroke. It reduced the demand for professional manpower while promoting upper limb recovery, particularly wrist–hand function, during the critical subacute neuroplasticity window. This approach could optimize rehabilitation resource allocation and facilitate more personalized interventions. Trial registration Chinese Clinical Trial Registry Identifier: ChiCTR2300074469. Registered on 2023/08/08.