A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF BOTULINUM TOXIN IN THE TREATMENT OF SPASTIC FOOT IN HEMIPARETIC PATIENTS

Objective-To confirm the apparent effectiveness of botulinum toxin (BT X) in hemiparetic patients with ankle plantar flexor and foot invertor spasticity. Methods-Twenty three hemiparetic patients with spasticity of the ankle plantar flexors and foot inverters were included in a ra ndomised double blind, placebo controlled study with BTX. Patients wer e examined on days 0, 30, 90, and 120 and received one injection of BT X and one of placebo in a random order at day 0 and day 90. Results-Pa tients reported a clear subjective improvement in foot spasticity afte r BTX (P = 0.0014) but not after placebo. Significant changes were not ed in Ashworth scale values for ankle extensors (P < 0.0001) and inver ters (P = 0.0002), and for active ankle dorsiflexion (P = 0.0001). Gai t velocity was slightly but not significantly (P = 0.0731) improved af ter BTX injections. The severity of spasticity did not modify treatmen t efficacy, but BTX was less effective in patients with longer duratio n of spasticity (P = 0.0081). Conclusion-The efficacy of BTX injection s in the treatment of spastic foot suggests that BTX may be particular ly useful during the first year after a stroke.