ACTRN12615001162505.

Trial name or title	Public title: The impact of Botox on muscle structure and function in children with CP Scientific title: A RCT of the efficacy of first intramuscular botulinum toxin type‐A treatment on muscle structure and function in children with CP: a multicenter trial
Methods	Multicentre RCT with 1 group receiving treatment at baseline and the other after a 6‐month waiting period (control)
Participants	Ambulatory children with CP and lower limb spasticity Target sample size: 50 Inclusion criteria: Confirmed diagnosis of unilateral or bilateral spastic‐type CP with a predominant spastic motor type and more involvement of the lower limb Aged 2 to 5 years at study entry GMFCS classification of I‐II independently ambulant Maximum passive ankle dorsiflexion greater than or equal to −5 degrees (5 degrees plantarflexed) Prescribed intramuscular BoNT‐A injection into the lower leg for spasticity treatment Sufficient co‐operation and cognitive understanding to participate in the assessments Either gender Exclusion criteria: Predominant lower limb dystonia motor type Previous lower limb intramuscular BoNT‐A injections Previous lower limb surgical interventions Contraindications for BoNT/A injection treatment
Interventions	BoNT‐A injections into gastrocnemius, soleus, and tibialis posterior muscles versus control group where no BoNT‐A was offered for a waiting period of 6 months
Outcomes	Muscle growth, gait quality, walking speed/step length, lower limb anaerobic power: ramp test, habitual physical activity
Starting date	9 November 2015
Contact information	Lee Barber (email: l.barber@uq.edu.au)
Notes	Comment: none Status: recruiting Date completed: not reported Last updated: 2 June 2017 Sponsor: CP Alliance Research Foundation