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

Abstract

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.

The Application of Soft Robotic Gloves in Stroke Patients: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

“…In subgroup analyses, patients who had reached chronic stroke status (latency >6 months) showed significant improvement in their FMA-UE score (MD 4.93, 95% CI: 0.93~8.93, I 2 = 19%), with those whose stroke latency was less than six months also showing significant improvement (MD 8.84, 95% CI: 4.47~13.22, I 2 = 0%). The three trials [ 15 , 17 , 19 ] which used the RAPAEL Smart Glove revealed significant improvement in FMA-UE scores (MD 8.43, 95% CI: 4.27~12.59, I 2 = 0%), as did the other four studies which involved other devices (MD 5.29, 95% CI: 0.90~9.67, I 2 = 27%). In the subgroup involving a training length of less than 30 min, significant improvement in FMA-UE scores was found (MD 5.85, 95% CI: 2.49~9.21, I 2 = 15%), with those trials whose training length was more than 30 min also showing significant improvement (MD 9.01, 95% CI: 2.77~15.26, I 2 = 3%).…”

“…After primary screening we identified 156 articles for use in our full-text assessment. Ultimately, eight studies were incorporated into our analysis involving a total of 309 participants after assessment for eligibility [ 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 ]. The flowchart of the selection procedure is shown in Figure 1 .…”

“…The characteristics of these studies are summarized in Table 1 , with each study’s SRG protocols summarized in Table 2 . Six trials measured FMA-UE [ 14 , 15 , 17 , 19 , 20 , 21 ], three calculated FMA-distal UE [ 17 , 19 , 20 ], four recorded JTT scores [ 15 , 17 , 18 , 19 ], three examined grip strength [ 16 , 18 , 19 ], while two studies examined BBT scores [ 19 , 21 ]. The total training duration ranged from two to four weeks.…”

“…According to the RoB 2.0, two RCTs [ 15 , 17 ] were considered to have a low risk of bias, while the other six [ 14 , 16 , 18 , 19 , 20 , 21 ] were rated as having some concerns. A summary of the risk of bias is shown in Figure 2 .…”

“…A total of 7 trials [ 14 , 15 , 17 , 19 , 20 , 21 ] involving 222 patients were included in the quantitative analysis ( Figure 3 ). A significant improvement in FMA-UE scores was demonstrated in those patients receiving therapy with SRGs through the assessment which was made immediately after the intervention (MD 6.52, 95% CI: 3.65~9.39, I 2 = 8%).…”