CTRI/2015/03/005642.

Trial name or title	Public title: Clinical trial to compare the effect of botulinum toxin versus surgical management of lower limb deformities in children with spastic CP Scientific title: Botulinum toxin versus single event multilevel surgery (SEMLS) in children with lower limb deformities in spastic CP ‐ a randomized comparative trial
Methods	RCT
Participants	Sample: children with CP and dynamic deformities of the lower limbs Target sample size: 50 Inclusion criteria: Aged 4 to 10 years old Either sex Known cases of CP with dynamic contractures of lower limb muscles Children with spastic CP with abnormal gait Children falling into GMFCS scores of I, II, and III Exclusion criteria: Having received botulinum toxin previously Having undergone previous surgical procedure for lower limb deformities Known cases of spastic CP with severe mental retardation Children falling into GMFCS grade IV or V Children with dyskinetic CP Children who are allergic to botulinum toxin Having received oral or intrathecal baclofen previously
Interventions	BoNT‐A injections versus multilevel orthopaedic surgery
Outcomes	Improvement in gait pattern, correction of deformity
Starting date	10 August 2012 (recruitment completed, study not published)
Contact information	Shah Alam Khan (email: shahalamkhan70@gmail.com) Mohammed Sadiq (email: sadiq22288@yahoo.com)
Notes	Comment: none Status: completed Date completed: not reported. Estimated duration of trial was 2 years. Last updated: 17 March 2017 Sponsor: other (participants would not incur any expense other than the treatment costs)