NCT02546999.

Trial name or title	Public title: Does botulinum toxin A make walking easier in children with CP? (WE) Scientific title: Does botulinum toxin A make walking easier in children with CP?
Methods	RCT
Participants	Sample: ambulatory children with CP and lower limb spasticity Target sample size: 96 Inclusion criteria: Either sex Aged 4 to 17 years Diagnosed with unilateral or bilateral CP GMFCS level I and II Signed informed consent Expected co‐operation of participants for treatment and follow‐up Exclusion criteria: BoNT‐A injections in the lower legs in the 6 months before intervention History of adverse reactions to BoNT‐A Known hypersensitivity to BoNT‐A or to any of the excipients Orthopaedic surgery in the legs in the last 2 years Major cognitive impairments (must be able to take verbal instructions and conduct the test procedure) Infection at the proposed injection site(s) Subclinical or clinical evidence of defective neuromuscular transmission, e.g. myasthenia gravis or Lambert‐Eaton syndrome in patients with peripheral motor neuropathic diseases (e.g. amyotrophic lateral sclerosis or motor neuropathy) Other underlying neurological disorders that could be affected by BoNT‐A injections Use of aminoglycoside antibiotics or spectinomycin, or other medicinal products that interfere with neuromuscular transmission (e.g. neuromuscular blocking agents) Pregnant or breastfeeding Childbearing potential and not using contraception Any reason why, in the opinion of the investigator, the patient should not participate Children needing deep sedation under treatment Healthy volunteers
Interventions	BoNT‐A injections versus placebo
Outcomes	Energy cost during walking, activity, perceived improved performance and satisfaction, recurrent musculoskeletal pain, walking capacity, gait pattern, ankle strength, spasticity, self‐perceived effect on walking
Starting date	September 2015
Contact information	Siri M Braendvik (email: siri.brendvik@stolav.no) Torstein Vik (email: torstein.vik@ntnu.no)
Notes	Comment: none Status: recruiting Date completed: estimated 31 December 2020 Last updated: 21 August 2019 Sponsor: St Olavs Hospital