Feasibility and preliminary efficacy of a soft robotic glove for hand rehabilitation in early subacute stroke: a pilot investigation

Vollständiger Abstract

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Abstract Objectives This pilot study aimed to investigate the feasibility, safety, and preliminary efficacy of a rehabilitation program utilizing Syrebo ™ SY-HR03E soft robotic glove with pneumatic actuators for hand function recovery in patients with early subacute stroke. Methods A single-blind pilot randomized controlled trial was conducted in an inpatient clinical setting. The intervention was administered 5 days per week for 4 weeks (20 session’s total). During this period, the robotic therapy (RT) group ( n = 10) received 30-min daily sessions with the soft robotic glove, while the conventional therapy (CT) group ( n = 10) received 30-min daily sessions of conventional hand therapy. Both groups additionally participated in an identical 1-h daily conventional rehabilitation program excluding hand training. The outcome measures included the Fugl–Meyer Assessment for the hand (FM-Hand) and upper limb (FM-UL), the modified Barthel index (MBI), and the Brunnstrom stages (BS). Intervention effects were analyzed using two-way repeated-measures ANOVA. Results All participants completed the intervention without dropouts or adverse events, confirming the feasibility and safety of the protocol. Baseline motor impairment was comparable between groups (FM-Hand: 2.20±1.93 vs. 2.50±2.64; FM-UL: 19.60±14.76 vs. 16.70±14.50). A significant Group × Time interaction was found for the FM-Hand [F(1,18) = 4.743, p < 0.05] and the MBI [F(1,18) = 7.728, p < 0.05]. Simple effects analysis revealed that both groups improved significantly in FM-Hand, while only the RT group showed a significant improvement in MBI after interventions. For the FM-UL, a significant main effect of Time [F(1,18) =24.931, p < 0.001] in both groups was observed without an interaction. In the BS, a significant main effect of Time was found for both hand and upper limb, with only the RT group showing significant within-group improvement for the hand. Conclusions Syrebo TM SY-HR03E soft robotic glove is a feasible and safe tool for hand rehabilitation in early subacute stroke. The results provide preliminary signals for improving hand function and translating gains into activities of daily living compared to conventional therapy alone. However, because both groups were in the early subacute stage, the observed gains likely reflect a combination of intervention effects and spontaneous recovery. These findings justify further investigation through larger-scale, definitive trials. Trial Registration : ChiCTR2000034614|| http://www.chictr.org.cn/ with the Clinical Trial Registry (2020/07/12).