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

PURPOSE: 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. METHODS: 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). RESULTS: 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]. CONCLUSION: 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.