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Effectiveness and safety of abobotulinumtoxinA in pediatric lower limb spasticity: A phase IV, prospective,
Mark E Gormley1, Edward Dabrowski2, Mauricio R Delgado3
1Gillette Children's Specialty Healthcare, St. Paul, MN, USA.
Insights
Repeated abobotulinumtoxinA injections effectively achieved patient goals in pediatric lower limb spasticity. This treatment option demonstrated a favorable safety profile with generally mild adverse events.
Area of Science:
- Neurology
- Pediatric Medicine
- Rehabilitation Medicine
Background:
- Pediatric lower limb spasticity (PLLS) impacts motor function and quality of life.
- Botulinum neurotoxin injections are a common treatment for spasticity.
- Longitudinal data on patient-centered outcomes with repeated abobotulinumtoxinA (AboBoNT-A) are valuable.
Purpose of the Study:
- To evaluate the long-term achievement of patient-centered functional goals using Goal Attainment Scaling Total (GAS T)-scores.
- To assess the efficacy and safety of repeated abobotulinumtoxinA (AboBoNT-A) injections in pediatric patients with lower limb spasticity over 30 months.
- To analyze outcomes across different patient subgroups, including ambulatory status and prior botulinum neurotoxin treatment.
Main Methods:
- Prospective observational study involving patients aged 2-17 years with pediatric lower limb spasticity.
- Goal Attainment Scaling Total (GAS T)-scores assessed longitudinally after each abobotulinumtoxinA injection cycle.
- Adverse events were systematically recorded to evaluate safety.
Main Results:
- Mean cumulative GAS T-score of 51.1 (9.3), indicating goal achievement exceeded expectations for 75.2% of patients.
- Comparable GAS T-scores between treatment-naïve and previously treated patients, and across age groups.
- Higher goal attainment in ambulatory versus non-ambulatory subgroups; generally mild to moderate adverse events reported.
Conclusions:
- AbobotulinumtoxinA (AboBoNT-A) effectively facilitated the achievement of patient-centered functional goals in pediatric lower limb spasticity.
- The treatment demonstrated a positive risk-benefit profile, with a low incidence of treatment-related adverse events.
- AboBoNT-A is a well-tolerated and effective therapeutic option for pediatric patients with lower limb spasticity across various disability levels.
Aim:
To assess the longitudinal attainment of patient-centered, function-related Goal Attainment Scaling Total (GAS T)-score after repeated abobotulinumtoxinA (AboBoNT-A) injections over a period of up to 30 months and up to 10 cycles.
Method:
In this prospective observational study, the investigators' clinical practices recruited patients aged 2 to 17 years with pediatric lower limb spasticity (PLLS). GAS T-scores were assessed for each injection, and goals could be redefined at each visit; scores of 50 reflected goal achievement. Adverse events were recorded.
Results:
Of 210 patients in the effectiveness population, 171 had cerebral palsy and 163 were previously treated with a botulinum neurotoxin. Available Gross Motor Function Classification System levels showed that 31.3% (61 out of 195) of patients were non-ambulatory. Mean (SD) cumulative GAS T-score was 51.1 (9.3) across the study duration; 75.2% achieved their primary goals. GAS T-scores were comparable between BoNT-naïve and previously treated patients and between age groups, but higher in the ambulatory than the non-ambulatory subgroup. Injection guidance techniques were used in more than 70% of patients in cycles 1 to 6. Of 242 patients in the safety population, 102 reported 392 treatment-emergent adverse events, including 15 reporting 35 treatment-related adverse events. Adverse events were generally mild to moderate.
Interpretation:
Overall, goals were achieved as, or better than, expected in most patients. AboBoNT-A was well tolerated, with a low incidence of treatment-related adverse events. These results indicate that AboBoNT-A is an effective treatment option, with a positive risk-benefit profile, for patients with PLLS across disability levels.
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