TCTR20150803003.

Trial name or title	Public title: Efficacy of botulinum toxin in pediatric spasticity: a randomized trial comparing 2‐ to 4‐sites hamstring injection Scientific title: Efficacy of botulinum toxin in pediatric spasticity: a randomized trial comparing 2‐ to 4‐sites hamstring injection
Methods	RCT
Participants	Sample: children with CP and lower limb spasticity Target sample size: 80 Inclusion criteria: Either sex Aged 2 to 7 years Children with CP with spasticity Modified Ashworth Scale Bohannon (MAS B) score 1, 2, and 3 in hamstring muscles Exclusion criteria: Prior surgery or accident in lower extremity muscles Injected with BoNT‐A in the 6 months before joining the study Allergic to the components of BoNT‐A Have a neuromuscular disease such as myasthenia gravis and Lambert‐Eaton syndrome or on medication that affects the use of BoNT‐A Have an easily bleeding tendency disease or on anti‐blood‐clotting medication Healthy volunteer
Interventions	BoNT‐A injections into the hamstrings (2 groups with different injection methods, using either 2 or 4 points) versus control with standard treatment
Outcomes	Range of motion, spasticity, gait, motor function, quality of life, satisfaction
Starting date	7 August 2015
Contact information	Chuenchom Chueluecha (email: puaichuenchom@hotmail.com)
Notes	Comment: none Status: recruiting Date completed: not reported Last updated: 16 November 2015 Sponsor: Thammasat University

BoNT‐A: botulinum toxin type A; CP: cerebral palsy; GMFCS: Gross Motor Function Classification System; RCT: randomised controlled trial.