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The problem
Intervention: AbobotulinumtoxinA injections at 8U/kg or 16U/kg into target muscles (wrist or elbow flexors) combined with home exercise therapy program (minimum five 15-minute sessions per week)
Who it was tested with: 210 children aged 2-17 years with cerebral palsy and upper limb spasticity (mean age 9 years; 126 male, 84 female).
Children or communities are compared with a group that did not receive the intervention, or followed over years. This is the design that best separates what the intervention did from everything else that changed.
"This was a double-blind, repeat-cycle study (NCT02106351) in children with CP (2-17y). Children were randomized to receive 2U/kg (control), 8U/kg, or 16U/kg abobotulinumtoxinA injections into the target muscle group (wrist or elbow flexors) and additional muscles alongside occupational therapy via a home-exercise therapy program." The randomized, double-blind design with control comparison groups and repeated measurement across multiple cycles provides strong evidence for the efficacy and safety of the intervention.
Study evaluated only upper limb spasticity; long-term effects beyond one year are unknown; the addition of structured home exercise therapy makes it difficult to isolate the effect of the injection alone.
Across countries and designs
1 study · 4 countries
