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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
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Scientific title
Evaluation of Single Event Multilevel Surgery on the gait of children with spastic diplegic Cerebral palsy
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Universal Trial Number (UTN)
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Trial acronym
SEMLS Trial
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy
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Condition category
Condition code
Surgery
4151
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Surgical techniques
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Surgery
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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gait kimematic measures namely the Gillette Gait Index
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Assessment method [1]
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Timepoint [1]
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baseline and 12 months post intervention
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Primary outcome [2]
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Gross motor function using the Gross motor Function Measure
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Assessment method [2]
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Timepoint [2]
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baseline and 12 months post intervention
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Primary outcome [3]
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health related quality of life measured using Child Health Questionnaire
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Assessment method [3]
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Timepoint [3]
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baseline and 12 months post intervention
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Secondary outcome [1]
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functional mobilty using the functional mobilty scale
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Assessment method [1]
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Timepoint [1]
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baseline, 3, 6, 9 and 12 months post intervention
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Secondary outcome [2]
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strength and range of joint motion by physiotherapist using a goniometer and strength by use of a hand held dynamometer
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Assessment method [2]
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Timepoint [2]
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baseline, 3,6,9,12 months post intervention
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Secondary outcome [3]
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physical activity - uptime that is the amount of time spent in the upright position per day measured by an positional activity logger
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Assessment method [3]
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Timepoint [3]
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baseline, 6 and 12 months post intervention
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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)
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Minimum age
7
Years
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Maximum age
12
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
hip migration greater than 20%, painful mid foot deformity, progressive crouch gait pattern
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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.
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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.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
5/10/2004
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Murdoch Childrens Research Institute
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Address [1]
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50 Flemington Road
Parkville 3052
Victoria
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Country [1]
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Australia
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Primary sponsor type
Individual
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Name
Prof Herbert Kerr Graham
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Address
Dept of Orthopaedics
Royal Childrens Hospital
50 Flemington Road
Parkville 3052
Victoria
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Country
Australia
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Secondary sponsor category [1]
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Individual
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Name [1]
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Richard Baker
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Address [1]
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Hugh Williamson Gait Laboratory
Gait Centre of Clinical Research Excellence
Royal Children's Hospital
50 Flemington Road
Parkville 3052
Victoria
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Country [1]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Ethics in Human Research Committee
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Ethics committee address [1]
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Royal Children's Hospital
50 Flemington Road
Parkville 3052
Victoria
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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Approval date [1]
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09/02/2004
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Ethics approval number [1]
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23144A
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Pam Thomason
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Address
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Hugh Williamson Gait Laboratory
Royal Children's Hospital
50 Flemington Road
Parkville 3052
Victoria
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Country
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Australia
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Phone
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+61393455354
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Fax
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+61393455447
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Email
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[email protected]
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Contact person for scientific queries
Name
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Pam Thomason
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Address
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Hugh Williamson Gait Laboratory
Royal Children's Hospital
50 Flemington Road
Parkville 3052
Victoria
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Country
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Australia
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Phone
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+61393455354
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Fax
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+61393455447
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Email
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[email protected]
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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.
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