The Effects of Botulinum Toxin a on Kinematics and Motor Control in Stroke Patients with Limbs Spasticity

Stroke often results in muscle over-activity which may cause musculoskeletal pain, deformity, gait disturbance and impaired motor control. Intra-muscular (IM) Botulinum toxin A (BTX-A) injection was widely used in management of muscle over-activity for its effectives, convenience and relative safety. This study will evaluate the therapeutic effect of lower extremity chemodenervation with Botulinum toxin (BTX-A) in improving gait pattern, plantar pressure distribution and motor control in stroke patients. The results may provide the evidence base for the clinical usage of BTX-A. We also hope to find out the predicting factors of choosing patient who may benefit from lower extremity IM BTX-A injection. The hypotheses of our study are lower extremity IM BTX-A injection (1) will improve some stroke patient’s gait performance and gait plantar pressure distribution; (2) will normalize some stroke patient’s motor control with more selective muscle contraction and less co-contraction and (3) we may predict which patients will benefit more from lower extremity IM BTX-A injection from the gathered data. This is a randomized, double-blind, placebo-controlled prospective study. Total 60 stroke subjects and 15 healthy subjects, aged 30-75 years, will be collected in this study. The stroke subjects will be enrolled to 2 groups: Group A (n=30) and Group B (n=30). The Group A and Group B subjects then were randomized to two subgroups separately, treatment group (n=15) and control group (n=15). IM BTX-A (treatment group) or normal saline injection (control group) will be given in the condition of double blind. The study will process in three years. In the first year, we will get the basic data, gait parameters (walking velocity, cadence, step length, stride time, percentage of single- and double-limb support), plantar pressure distribution (gaitline and cyclogram), poly-electromyography (PEMG) data during gait and lower limb flexion movement protocol of brain motor control assessment (LFMP of BMCA) in supine position and SF 36 score in normal and stroke subjects. . In the second year, BTX-A or normal saline injections will be arranged in Group A subjects on the overactive muscles of lower extremity. We will follow up the basic data, gait parameters, plantar pressure distributions and SF 36 score after 3 weeks, 3 months and 6 months. In the third year, we will arrange BTX-A injections or normal saline injections in Group B subjects on the overactive muscles of lower extremity. We will follow up the basic data, PEMG data during gait and LFMP of BMCA and SF 36 score after 3 weeks, 3 months and 6 months. The expected results and contributions: 1. Compare the gait parameter, plantar pressure distribution and PEMG data between stroke subjects and normal subjects to understand the gait performance and motor control pattern in stroke patients. 2. Compare the gait parameter, plantar pressure distribution and PEMG data before and after IM lower extremity BTX-A injection. These data will provide evidence base of BTX-A usage in lower extremity of stroke patients 3. Finding out predicting factors for choosing stroke patients who may benefit more from lower extremity IM BTX-A injection.

Project ID:PC9902-0205
External Project ID:NSC97-2314-B182-039-MY3