Safety and efficacy of repeat long-term incobotulinumtoxinA treatment for lower limb or combined upper/lower limb spasticity in children with cerebral palsy.
Petr Kaňovský, Florian Heinen, A Sebastian Schroeder and 8 others
PMID 34957963WHAT IT FOUND
Repeat incobotulinumtoxinA injections for lower limb spasticity in children with cerebral palsy were well-tolerated over four to six cycles.
Muscle tone improved consistently, and gross motor scores rose by 4.8 points at the final visit. Most adverse events were mild respiratory infections.
Key findings
01Treatment-emergent adverse events occurred in 29.5% of patients, with only 2.7% considered treatment-related and no deaths reported.
02Plantar flexor spasticity improved significantly from baseline at week 4 of each injection cycle, with this effect seen across all Gross Motor Function Classification System levels.
03Gross Motor Function Measure-66 scores improved by a mean of 4.8 points from baseline to the end-of-study visit, though this benefit cannot be attributed solely to the injection due to concurrent therapy.
STILL TO COME
How it was doneWhat they foundWhat it means for PTsWhat it means for OTs
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What it does not show
The study was open-label and non-controlled, meaning there was no placebo group to compare against. No formal sample size calculation was performed, and analyses were descriptive. Neither gait in ambulatory patients nor quality of life was evaluated. Many patients received concurrent therapies (physiotherapy, OT, casting, orthotics), making it impossible to separate the specific contribution of the botulinum toxin from these interventions.
Declared interests
The text states the study was supported by non-U.S. government funds but does not list specific corporate sponsorships or author conflicts of interest in the provided excerpt.
The easy way to misread this
Do not interpret the 4.8-point improvement in gross motor scores as a direct effect of the injection alone. Patients continued to receive physiotherapy, occupational therapy, and other rehabilitation measures throughout the study, so the contribution of any single component cannot be separated.