None listed
Conditions
Brief summary
Single event Multilevel surgery, usually called SEMLS is a program that involves more than one operation on bones and or muscles carried out at the same time. The surgery is to correct problems that stop you being able to stand up straight and walk properly. The benefit of having the operations all at one time is that you only need to come into hospital once and be put to sleep once. No one has ever proved that the surgery is successful or measured exactly what differences the surgery makes. this is the aim of this study. To do this we are dividing the children who are going to have surgery into two groups. The timing of the surgery is not that important so one group will have surgery now and the other in a year's time. We will monitor both groups over this year allowing us to compare progress in both groups.
Interventions
Single Event Multilevel Surgery is the orthopaedic surgical program of simultaneous correction of musculoskeletal contractures and deformities in the lower limbs of children with cerebral palsy. This involves multiple surgical procedures to lengthen muscles and correct bony deformity. This is individualized to each participant based on physical findings and the results of instrumented gait analysis. It is expected that there will be an improvment in the participant's walking ability and motor fu
Single Event Multilevel Surgery is the orthopaedic surgical program of simultaneous correction of musculoskeletal contractures and deformities in the lower limbs of children with cerebral palsy. This involves multiple surgical procedures to lengthen muscles and correct bony deformity. This is individualized to each participant based on physical findings and the results of instrumented gait analysis. It is expected that there will be an improvment in the participant's walking ability and motor function. Following initial assessment participants will be randomised to one of two groups. The first group will proceed to surgery straight away, the second group (control) will receive their suregry in 12 months time. This intervention is a once off procedure. Surgery is followed by a period of restricted mobilty, then fan intensive rehabilitation program with physiotherapy 3 times per week for a 3 month period. Following surgery the participants will be assessed at 3 months intervals, for 12 months. They will then have one further follow up at 24 months post the intervention.
Sponsors
Prof Herbert Kerr Graham
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
7 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
children with spastic diplegic cerebral palsy who are classified as Gross Motor Function Classification Level II or III who have been identified as requiring Single Event Multilevel Surgery (SEMLS)
Exclusion criteria
hip migration greater than 20%, painful mid foot deformity, progressive crouch gait pattern
Outcome results
None listed