At a glance
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An International, Multicentre, Prospective, Single-Arm Study to Assess the Effect on Voluntary Movements of AbobotulinumtoxinA 1500 U Administered in Both Upper and Lower Limbs in Conjunction With a Guided Self-Rehabilitation Contract in Adult Subjects With Spastic Hemiparesis
In Brief
A Phase 4 clinical trial evaluating Botulinum toxin type A and GSC for Spastic Hemiparesis. Completed, enrolled 157 participants across 19 sites in 4 countries.
Detailed Summary
The purpose of this clinical study is to assess whether AbobotulinumtoxinA (Dysport®) injections in upper and lower limbs accompanied with a personal exercise plan called "Guided Self-rehabilitation Contract" (GSC) can improve voluntary movements in subjects with hemiparesis.
Study Details
Timeline
Interventions
Dysport® administered in both upper and lower limbs (total dose of 1500 U per injection split between the 2 limbs).
The GSC is a motivational tool. The physiotherapist will teach each subject the stretching postures and exercises to perform on a daily basis throughout the study. These will be tailored to the individual subject's needs and will form the GSC therapy.