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Trial registered on ANZCTR


Registration number
ACTRN12609001047280
Ethics application status
Approved
Date submitted
9/11/2008
Date registered
8/12/2009
Date last updated
8/12/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of Single Event Multilevel Surgery in children with spastic diplegic cerebral palsy: A randomised clinical trial
Scientific title
Evaluation of Single Event Multilevel Surgery on the gait of children with spastic diplegic Cerebral palsy
Universal Trial Number (UTN)
Trial acronym
SEMLS Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy 3957 0
Condition category
Condition code
Surgery 4151 4151 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 3671 0
Treatment: Surgery
Comparator / control treatment
The group in which surgery is delayed by 12 months (control group) will undertake a progressive resistance strength training(PRST) program This is used in the control group to match the intensive rehabilitation received by the treatment group following surgery. These participants will undertake a 3 times per week PRST program with their physiotherapist for 12 weeks with each session lasting up to an hour. This is carried out between 3-6 months period in the trial. The expected outcome in the control group is no change in gait or function over the 12month study period. The control group participants will be assessed at 3 monthly intervals, for 12 months. The control group will then proceed to surgery.
Control group
Active

Outcomes
Primary outcome [1] 5048 0
gait kimematic measures namely the Gillette Gait Index
Timepoint [1] 5048 0
baseline and 12 months post intervention
Primary outcome [2] 5049 0
Gross motor function using the Gross motor Function Measure
Timepoint [2] 5049 0
baseline and 12 months post intervention
Primary outcome [3] 5050 0
health related quality of life measured using Child Health Questionnaire
Timepoint [3] 5050 0
baseline and 12 months post intervention
Secondary outcome [1] 8494 0
functional mobilty using the functional mobilty scale
Timepoint [1] 8494 0
baseline, 3, 6, 9 and 12 months post intervention
Secondary outcome [2] 8495 0
strength and range of joint motion by physiotherapist using a goniometer and strength by use of a hand held dynamometer
Timepoint [2] 8495 0
baseline, 3,6,9,12 months post intervention
Secondary outcome [3] 8496 0
physical activity - uptime that is the amount of time spent in the upright position per day measured by an positional activity logger
Timepoint [3] 8496 0
baseline, 6 and 12 months post intervention

Eligibility
Key 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)
Minimum age
7 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
hip migration greater than 20%, painful mid foot deformity, progressive crouch gait pattern

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Children consecutively recruited from the Hugh Williamson Gait Laboratory and Orthopaedic clinics of the Royal Children's Hospital Melbourne by the investigators. Once recriuted and consent signed children's information will be deidentified and allocated to treatment groups by an independent statistician "off-site" via the process of minimisation using a computer program.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
process of minimisation based on the predetermined criteria of Gross Motor Function Classification System (GMFCS) Level II or III, age less than or greater than 9 years and type of surgery required that is either soft tissue or bony only or both. This is done via a computer program.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/10/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4136 0
Charities/Societies/Foundations
Name [1] 4136 0
Murdoch Childrens Research Institute
Country [1] 4136 0
Australia
Primary sponsor type
Individual
Name
Prof Herbert Kerr Graham
Address
Dept of Orthopaedics
Royal Childrens Hospital
50 Flemington Road
Parkville 3052
Victoria
Country
Australia
Secondary sponsor category [1] 3721 0
Individual
Name [1] 3721 0
Richard Baker
Address [1] 3721 0
Hugh Williamson Gait Laboratory
Gait Centre of Clinical Research Excellence
Royal Children's Hospital
50 Flemington Road
Parkville 3052
Victoria
Country [1] 3721 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6206 0
Ethics in Human Research Committee
Ethics committee address [1] 6206 0
Royal Children's Hospital
50 Flemington Road
Parkville 3052
Victoria
Ethics committee country [1] 6206 0
Australia
Date submitted for ethics approval [1] 6206 0
Approval date [1] 6206 0
09/02/2004
Ethics approval number [1] 6206 0
23144A

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29114 0
Address 29114 0
Country 29114 0
Phone 29114 0
Fax 29114 0
Email 29114 0
Contact person for public queries
Name 12271 0
Pam Thomason
Address 12271 0
Hugh Williamson Gait Laboratory
Royal Children's Hospital
50 Flemington Road
Parkville 3052
Victoria
Country 12271 0
Australia
Phone 12271 0
+61393455354
Fax 12271 0
+61393455447
Email 12271 0
[email protected]
Contact person for scientific queries
Name 3199 0
Pam Thomason
Address 3199 0
Hugh Williamson Gait Laboratory
Royal Children's Hospital
50 Flemington Road
Parkville 3052
Victoria
Country 3199 0
Australia
Phone 3199 0
+61393455354
Fax 3199 0
+61393455447
Email 3199 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.