The safety and efficacy of repeat injections of botulinum toxin A (BTX-A) into the upper limb of children with spastic hemiplegic cerebral palsy (CP) who are receiving occupational therapy has not yet been investigated by use of prospective clinical protocols.OBJECTIVE
To assess the safety and efficacy of repeat BTX-A injections into the upper limb as an adjunct to occupational therapy in children with spastic hemiplegic CP.DESIGN AND INTERVENTION
This study was designed as an evaluator-blinded, randomized, controlled and prospective trial. It included 42 children with hemiplegic CP (Gross Motor Function Classification System level I; mean ± SD age 4 ± 1.61 years; 31 boys, 11 girls), all of whom received occupational therapy. In addition, 21 children (group A) received three series of BTX-A injections (at 0,6 and 18 months) and the remaining 21 children (group B) received two series of BTX-A injections (at 6 and 18 months), at a mean total dose of 1.5 units/kg per injection. The following muscles were injected: elbow flexors, forearm pronators, wrist flexors, wrist extensors, finger flexors, thumb adductor, thumb opponens, and thumb flexor. Selection of muscles for injection was based on the following parameters: baseline score of ≥2 on the Ashworth Scale; estimated effect of treatment on functional abilities; and parental preference of likely arm posture if BTX-A was effective. Patients were followed up until month 30.OUTCOME MEASURES
Outcome measures were the Quality of Upper Extremity Skills Test (QUEST), the Ashworth Scale, Goal Attainment Scaling (GAS), the Canadian Occupational Performance Measure (COPM), and the Pediatric Evaluation of Disability Inventory (PEDI). Adverse events were also recorded.RESULTS
At 30 months, the two groups did not differ significantly in any of the outcome measures, so the participants were treated as a single cohort in order to examine the effect of repeat injections. QUEST indicated an improvement in arm movement of 5.5 points (out of a maximum of 100 points) for the first injection series (P=0.01) and of another 4.5 points for the second injection series (P=0.03). Results on parent GAS indicated achievement of predetermined family goals, with function and participation improving by 3.5 T-scores after the first injection (P=0.02) and by another 3.9 T-scores after the second injection (P=0.01); respective improvements on therapist GAS were 7.8 T-scores (P<0.0001) and 4.0 T-scores (P=0.03).COPM function and participation improved by 0.35 points (out of a maximum of 10 points; P=0.05)and by an additional 0.42 points (P=0.02)after the first and second injections, respectively, and PEDI-functional skills improved by 1.8 points (out of a maximum of 73 points; P<0.0001) and by another 2.3 points (P=0.04), respectively. The third injection series in group A had no statistically significant effect on any outcome measure. There were no adverse effects that were considered to be related to BTX-A treatment.CONCLUSION
Repeat BTX-A injections are well tolerated and are effective in improving movement and function in children with CP who are receiving occupational therapy.