RCT of first Botulinum toxin-A on muscle structure/function in children with CP

Chief Investigators: AI Barber, CI Boyd (QLD), CI Elliott (WA), (VIC) CP Foundation (2014-2016) $195,467.

Description: Intramuscular injections of Botulinum toxin type-A (BoNT-A) reduces spasticity in children with CP, however it can also reduce muscle growth and strength. As BoNT-A is the most common treatment for spasticity in CP there is an urgent need to understand the effects on muscle growth and strength.

Aim: To determine the impact of BoNT-A on calf muscle growth/structure and functional capacity in children with CP naïve to BoNT-A using innovative ultrasound methods (2D/3D).

Design: Randomised, wait-list controlled, assessor-blinded trial. As there are no previous RCTs examining BoNT-A on medial gastrocnemius muscle, a pre/post comparison of CP and Typically Developing Children (TDC) found growth slowed by >35% post-BoNT-A (ES 1.44 year) compared to TDC (ES 0.90). To detect differences with >90% power requires 50 infants with spastic type CP aged 2-5years (25 Rx/ 25 Control), and 25 age matched TDC.

Methods: Primary: muscle cross sectional area. Secondary: lower limb anaerobic power, habitual physical activity outcomes.

New knowledge: Recruitment across 3 sites has commenced, which will provide pilot data for a larger RCT of BoNT-A on longitudinal muscle growth in CP.

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