Treatment of adductor spasticity with BTX‐A in children with CP: a randomized, double‐blind, placebo‐controlled study

Abstract

Adductor spasticity in children with cerebral palsy (CP) impairs motor function and development. In a placebo‐controlled, double‐blind, randomized multicentre study, we evaluated the effects of botulinum toxin A(BTX‐A) in 61 children (37 males, 24 females; mean age 6 years 1 month [SD 3y 1mo]) with CP (leg‐dominated tetraparesis, n=39; tetraparesis, n=22; GMFCS level I, n=3; II, n=6; III, n=17; IV, n=29; V, n=6). Four weeks after treatment, a significant superiority of BTX‐A was observed in the primary outcome measure (knee‐knee distance ‘fast catch’, p=0.002), the Ash worth scale (p=0.001), and the Goal Attainment Scale (p=0.037).

Goal attainment scaling in paediatric rehabilitation: a critical review of the literature

“…18 In these studies, a total of 284 children were assessed with 859 GAS scales of varying quality, using a variety of scale development techniques in the different study designs. Five recent studies 3,18,19,20,23 evaluated BTX-A treatment. These studies found significant and clinically relevant effects of treatment with BTX-A as measured by GAS.…”

“…Most of the goals set in the six studies were in the areas of activities and participation, but body function goals, such as gait pattern 19,23 and range of motion, 18 were also assessed. The results of these studies show that GAS is sensitive to change when used to measure an effect of BTX-A and an effect of functional training in children.…”

“…The results of these studies show that GAS is sensitive to change when used to measure an effect of BTX-A and an effect of functional training in children. Mall et al 19 and Paolicelli 23 discussed the failure of the Gross Motor Function Measure (GMFM) to detect superiority of BTX-A treatment and the sensitivity of GAS to change at the International Classification of Functioning, Disability and Health (ICF) activity level. Another study, using a multiple baseline/treatment phase design and blinded scoring of scales by means of videotape recordings, found a high level of evidence of good responsiveness for GAS.…”

“…Extra caution is required when goals at both the ICF activity/participation level and body function level are used and weighted, as was done in the studies by Lowe et al 18 and Mall et al 19 For example,'knee-knee distance' 19 is not an outcome measure provided by the child itself, but it is more reliable than a GAS scale on climbing stairs.…”

“…21 These are all factors that necessitate training in GAS. Although a double-blind randomized design (such as that of Mall et al 19 ) can prevent therapist bias, even in the best trials the reliability of functional rating on GAS scales for children depends on the children's psychomotor control, fatigue, motivation, interpersonal interaction with the therapist, and behaviour. A multiple baseline/treatment phase design 3 is able to compensate for the changes in the children's psychomotor control, but puts a great burden on the participants.…”