Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00419432
Protocol/serial number
MCT-99826
Study information
Scientific title
Functional outcomes following orthopaedic surgery based on gait laboratory versus observational gait analysis in ambulatory children with cerebral palsy: a multicentre pilot randomised controlled trial
Acronym
Study hypothesis
For ambulatory children with cerebral palsy (CP) who undergo multi-level lower extremity orthopaedic surgery, the addition of gait analysis for surgical decision-making compared with observational analysis alone, results in greater improvement in function and/or gait appearance 2 years after surgery.
Specific objectives of the pilot trial:
The goal of this pilot trial is to establish the feasibility of, and to provide the template for the design and implementation of the definitive large multicentre trial to answer the question above. The specific objectives include:
1. Establish the feasibility of implementing the randomised trial study design in multiple centres
2. Estimate recruitment rates and timelines
3. Establish responsiveness of outcome measures to finalise the primary and secondary outcomes
4. Estimate effect sizes of functional outcomes for sample size calculations
5. Establish data management system (web-based database) for definitive multicentre study
6. Assess feasibility, reliability and face validity of pilot health economic data forms to include health economic evaluation in the future definitive multicentre trial
Secondary objectives include:
7. Does the addition of gait analysis alter surgical decisions made from video observation alone, when performed in the setting of this pilot trial?
8. Evaluate the consistency of the surgical decision making: intra- and inter-rater reliability
Ethics approval
1. Canada: Research Ethics Board (REB) of The Hospital for Sick Children approved in October 2006 (ref: 1000009387); reviewed and approved annually
2. Canada: REB of Bloorview Kids Rehab approved in February 2007 (ref: 06-013); reviewed and approved annually
Approval pending from:
3. Canada: REB of British Columbia Children's Hospital
4. Canada: REB of Glenrose Rehabilitation Hospital
5. USA: Institutional Review Board (IRB) of the University of Wisconsin
All other centres will seek ethics approval before recruiting participants.
Study design
Multicentre patient and outcomes-assessor blinded pilot randomised controlled clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cerebral palsy
Intervention
Children allocated to Group A (controls) will undergo orthopaedic surgery based on the physical examination and observational analysis of the gait alone, while children allocated to Group B (experimental) will undergo orthopaedic surgery using the physical examination, observational and the gait laboratory analysis data.
Treatment in this case is an assessment (gait, PT and questionnaires lasting approximately 4 hours) at baseline, 6, 12 and 24 months follow-up. The exact same procedures apply to each arm of the study (it is the information from the gait assessment that may or may not be given to the surgeon depending on randomisation), therefore any child on the study can expect to participate for 24 months.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Gross Motor Function Measure (GMFM-66)
2. Gillette Gait (Normalcy) Index (GGI)
3. Pediatric Outcomes Data Collection Instrument (PODCI)
4. Functional Assessment Questionnaire (FAQ)
5. Functional Mobility Scale (FMS)
6. Activities Scale for Kids (ASK-performance)
7. Gait Parameters: gait velocity and stride length
The final primary and secondary outcome measures will be chosen based on responsiveness and their effect sizes used to calculate sample size for the definitive trial
Secondary outcome measures
Consistency of Surgeons' Decision Making: intra- and inter-rater reliability
The final primary and secondary outcome measures will be chosen based on responsiveness and their effect sizes used to calculate sample size for the definitive trial
Overall trial start date
01/03/2010
Overall trial end date
01/08/2013
Reason abandoned
Eligibility
Participant inclusion criteria
1. Diagnosis of spastic cerebral palsy
2. Age 6 to 15 years at the time of the initial assessment, either sex
3. Gross Motor Function Classification System (GMFCS) levels II or III (demonstrable independent ambulatory potential with or without orthotics/assist devices)
4. Patients have been referred for assessment and treatment of gait abnormality
5. Patients have a gait abnormality interfering with their physical function
6. Patients are candidates for orthopaedic surgery including soft tissue and/or bony procedures involving at least 2 levels, in one or both lower extremities (e.g. knee and ankle)
7. Patients must be able to undergo instrumented gait analysis testing in a motion laboratory
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
50
Participant exclusion criteria
1. Presence of dystonia, athetosis, or mixed tone abnormalities
2. History of orthopaedic lower extremity procedures within the previous 2 years
3. Patients who have had previous gait laboratory analysis that has been seen by the treating surgeon
4. Patients who will be unable to return for the required follow up visits/gait analysis
Recruitment start date
01/03/2010
Recruitment end date
01/08/2013
Locations
Countries of recruitment
Canada, United States of America
Trial participating centre
Division of Orthopaedic Surgery
Toronto
M5G 1X8
Canada
Sponsor information
Organisation
Bloorview Kids Rehab (Canada)
Sponsor details
150 Kilgour Road
Toronto
M4G 1R8
Canada
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-99826)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Bloorview Children's Hospital Foundation (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary