A Pilot Randomized Controlled Trial of Botulinum Toxin Treatment Combined with Robot-Assisted Therapy, Mirror Therapy, or Active Control Treatment in Patients with Spasticity Following Stroke.

Effects of the combined task-oriented trainings with botulinum toxin A (BoNT-A) injection on improving motor functions and reducing spasticity remains unclear. This study aims to investigate effects of 3 task-oriented trainings (robot-assisted therapy (RT), mirror therapy (MT), and active control treatment (AC)) in patients with stroke after BoNT-A injection. Thirty-seven patients with chronic spastic hemiplegic stroke were randomly assigned to receive RT, MT, or AC following BoNT-A injection over spastic upper extremity muscles. Each session of RT, MT, and AC was 75 min, 3 times weekly, for 8 weeks. Outcome measures were assessed at pretreatment, post-treatment, and 3-month follow-up, involving the Fugl-Meyer Assessment (FMA), Modified Ashworth Scale (MAS), Motor Activity Log (MAL), including amount of use (AOU) and quality of movement (QOM), and arm activity level. All 3 combined treatments improved FMA, MAS, and MAL. The AC induced a greater effect on QOM in MAL at the 3-month follow-up than RT or MT. All 3 combined trainings induced minimal effect on arm activity level. Our findings suggest that for patients with stroke who received BoNT-A injection over spastic UE muscles, the RT, MT, or AC UE training that followed was effective in improving motor functions, reducing spasticity, and enhancing daily function.