AIM To test the effectiveness of repeat botulinum toxin A (BoNT-A) injections in the affected arm of 22 children with hemiplegic cerebral palsy (19 males, three females), aged 1 year 10 months to 4 years 10 months (mean 3y 8mo, SD 9mo) in a randomized controlled trial.METHOD Children received either three series of BoNT-A injections plus twice-weekly occupational therapy (OT) or OT alone in 16-week cycles. Muscles targeted at each injection cycle in the 11 children receiving BoNT-A+OT were the adductor pollicis (n=9), flexor pollicis longus (n=5), flexor digitorum superficialis (n=8), flexor digitorum profundus (n=8), flexor carpi radialis (n=2), flexor carpi ulnaris (n=6), pronator teres (n=10), and biceps brachii (n=11). Parental perception of treatment efficacy was assessed using the Canadian Occupational Performance Measure (COPM) and the Goal Attainment Scale (GAS), quality of movement using the Quality of Upper Extremity Skills Test (QUEST), fine motor skills using the Peabody Developmental Motor Scale -Fine Motor (PDMS-FM), and spasticity using the Modified Tardieu Scale (MTS). Between-group differences at 12 months were analysed using independent-sample t-tests.
RESULTSAll children were at Gross Motor Function Classification System levels I (BoNT-A+OT n=6; OT n=8) or II (n=5 and n=3 respectively) and were too young to be classified using the Manual Ability Classification System. The BoNT-A+OT group had higher COPM performance scores (mean difference )0.8, 95% confidence interval [CI] )1.5-0.0) and higher GAS T scores (mean difference )6.9, 95% CI )13.8 to )0.1]). No significant difference was found for the COPM satisfaction, PDMS-FM, or QUEST scores. The BoNT-A+OT group showed progressive reduction in spasticity compared with the OT group. At study completion MTS mean difference was 50.0°(95% CI 22.4-77.6) for pronators and 20.9°(95% CI 2.4-39.4) for wrist flexors.INTERPRETATION Repeat BoNT-A injections in the upper limb combined with OT resulted in progressively reduced spasticity and improved parental perception of performance.Cerebral palsy (CP) is the most common upper motor neuron disorder in children.1 Hemiplegic CP, implying unilateral involvement, is the second most common syndrome seen in children with CP.2 Although children with hemiplegic CP will generally gain the ability to walk and to perform most activities of daily living with one arm, these children nevertheless experience high levels of functional and cosmetic disability.There have been numerous studies assessing the efficacy of botulinum toxin A (BoNT-A) for the management of spasticity in the upper limb of children with CP, providing supportive evidence for the beneficial effect of a single treatment episode for reducing spasticity and improving goal achievement.3-5 However, to our knowledge, at the commencement of the present study there had been no reported randomized controlled trial (RCT) of the effectiveness of repeat BoNT-A injections in the upper limb.In this study, we examined the effect of repeat BoNT-A injections in the hemi...