Intramuscular botulinum toxin prior to comprehensive rehabilitation has no added value for improving motor impairments, gait kinematics and goal attainment in walking children with spastic cerebral palsy
Fabienne Schasfoort, Robert Pangalila, Emiel M. Sneekes, Coriene Catsman, Jules Becher, Herwin Horemans, Henk J. Stam, Annet J. Dallmeijer, Johannes B.J Bussmann
Rehabilitation Medicine, Erasmus MC, 3000 CA Rotterdam, The Netherlands. E-mail: email@example.com
Objective: Botulinum toxin (BoNT-A) is widely used in combined treatment for spastic cerebral palsy, but its added value preceding comprehensive rehabilitation for motor impairments, gait, and goal attainment
has not been studied.
Design: A comparative multi-centre trial, in which two groups underwent comprehensive rehabilitation (i.e. high-intensive functional physiotherapy, and indicated casting/orthoses). One group received intramuscular BoNT-A prior to rehabilitation, and the other group did not receive BoNT-A.
Subjects/patients: Children with spastic cerebral palsy, Gross Motor Function Classification System (GMFCS) levels I–III, age range 4–12 years, indicated for BoNT-A treatment regarding mobility problems.
Methods: Sixty-five children participated (37 boys), mean age 7.3 years (standard deviation (SD) 2.3, range 4–12 years), equally distributed across GMFCS levels. Forty-one children received BoNT-A+ comprehensive rehabilitation and 24 received comprehensive rehabilitation only. Functional leg muscle strength, passive range of motion, angle of catch, cerebral palsy-related pain, walking speed, kinematic gait parameters, goal attainment, and proxy-reported general functioning were assessed at baseline, primary end-point (12 weeks) and 24-week follow-up.
Statistical analyses were performed with linear mixed models.
Results: At the primary end-point there were no statistically significant differences in treatment effects between the groups, except for the angle-of-catch of the rectus femoris, which was in favour of comprehensive rehabilitation without BoNT-A (12° difference, 95% confidence interval (95% CI) 2:23, p = 0.025). Results at follow-up were similar.
Conclusion: At the group level, treating with BoNT-A prior to comprehensive rehabilitation did not add to the clinical effectiveness of rehabilitation. Thus, BoNT-A prescription and use should be critically reconsidered in this cerebral palsy age- and GMFCS-subgroup.
For children with spastic cerebral palsy who are able to walk independently, botulinum toxin injections are often part of a combined treatment to improve their functioning. Although it is known from the scientific literature that such combinations are more effective than low-intensity standard care, the relative contribution of the costly botulinum toxin injections to the total treatment effect is unknown. The aim of this study was to determine the added value of providing botulinum toxin treatment prior to a period of comprehensive rehabilitation compared with comprehensive rehabilitation alone in a group of 65 children aged 4–12 years. The effect outcomes measured were: leg muscle strength, muscle length and spasticity of several leg muscles, CP-related pain, walking speed, several gait pattern parameters, the degree to which individual therapy goals were attained, and parent-reported general functioning. At the group level, no differences were found in effect between the group that received botulinum toxin injections and comprehensive rehabilitation, and the group that received comprehensive rehabilitation alone. This suggests that the widespread prescription and use of botulinum toxin for spastic cerebral palsy in this age- and severity-subgroup needs critical reconsideration.
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