A Smart Glove Digital System Promotes Restoration of Upper Limb Motor Function and Enhances Cortical Hemodynamic Changes in Subacute Stroke Patients with Mild to Moderate Weakness: A Randomized Controlled Trial

This study was a randomized controlled trial to examine the effects of the RAPAEL(®) Smart Glove digital training system on upper extremity function and cortical hemodynamic changes in subacute stroke patients. Of 48 patients, 20 experimental and 16 controls completed the study. In addition to conventional occupational therapy (OT), the experimental group received game-based digital hand motor training with the RAPAEL(®) Smart Glove digital system, while the control group received extra OT for 30 min. The Fugl-Meyer assessment (UFMA) and Jebsen-Tayler hand function test (JTT) were assessed before (T0), immediately after (T1), and four weeks after intervention (T2). Cortical hemodynamics (oxyhemoglobin [OxyHb] concentration) were measured by functional near-infrared spectroscopy. The experimental group had significantly better improvements in UFMA (T1-T0 mean [SD]; Experimental 13.50 [7.49]; Control 8.00 [4.44]; p = 0.014) and JTT (Experimental 21.10 [20.84]; Control 5.63 [5.06]; p = 0.012). The OxyHb concentration change over the ipsilesional primary sensorimotor cortex during the affected wrist movement was greater in the experimental group (T1, Experimental 0.7943 × 10(−4) μmol/L; Control −0.3269 × 10(−4) μmol/L; p = 0.025). This study demonstrated a beneficial effect of game-based virtual reality training with the RAPAEL(®) Smart Glove digital system with conventional OT on upper extremity motor function in subacute stroke patients.