Effectiveness of soft robotic glove versus repetitive transcranial magnetic stimulation in post-stroke patients with severe upper limb dysfunction: A randomised controlled trial.

Abstract

To explore the difference in rehabilitation effect between soft robot gloves and repetitive transcranial magnetic stimulation (rTMS) in patients with severe upper limb motor dysfunction after a stroke. A total of 69 post-stroke patients with severe upper limb dysfunction were randomly assigned to a repetitive transcranial magnetic group, a soft robotic glove group, and a conventional treatment group. The primary outcomes were the Fugl-Meyer Upper Extremity Assessment (FMA-UE) and the Modified Barthel Index (MBI). The secondary endpoints were the amplitude surface electromyogram of the extensor wrist muscle (sEMG) and the cerebral hemispheric resting motor threshold (RMT). The change of FMA-UE score in the soft robotic glove group was significantly better than that in the conventional treatment group (median difference: 2 points; 95% confidence interval [1, 3]; P < 0.05), but there was no significant difference compared with the repetitive transcranial magnetic stimulation group (median difference: 0 points; 95% confidence interval [-1, 2]; P [0.547] > 0.05). There was no significant difference in the change of MBI score between the soft robotic glove group and the conventional treatment and repetitive transcranial magnetic treatment groups [F = 2.458, P [0.093] > 0.05]. There was no significant difference in the change of sEMG score between the soft robotic glove group and the conventional treatment and repetitive transcranial magnetic treatment groups [H = 0.042, P [0.980] > 0.05]. Additionally, the change of RMT score in the soft robotic glove group was significantly inferior to that in the repetitive transcranial magnetic treatment group [difference: -1.09; 95% confidence interval [-2.048, 0.048]; P < 0.05], but there was no significant difference compared with the conventional treatment group [difference: 0.31 points; 95% confidence interval [-0.879, 0.358]; P [0.495] > 0.05]. For patients with severe dyskinesia after a stroke, soft robotic gloves are as effective as repetitive transcranial magnetic stimulation and may be a good choice for home rehabilitation. In addition, conventional treatment combined with repetitive transcranial magnetic stimulation (rTMS) or a soft robotic glove produced better rehabilitation outcomes than conventional treatment alone.