Does the use of gait analysis for decision making, improve outcomes of surgery for children with cerebral palsy?

ISRCTN	ISRCTN51084195
DOI	https://doi.org/10.1186/ISRCTN51084195
ClinicalTrials.gov (NCT)	NCT00419432
Protocol serial number	MCT-99826
Sponsor	Bloorview Kids Rehab (Canada)
Funders	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-99826), Bloorview Children's Hospital Foundation (Canada)

Submission date: 25/02/2010
Registration date: 08/03/2010
Last edited: 11/04/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Unni G. Narayanan
Scientific

Division of Orthopaedic Surgery
The Hospital for Sick Children
555 University Avenue, S-107
Toronto
M5G 1X8
Canada

Study information

Primary study design	Interventional
Study design	Multicentre patient and outcomes-assessor blinded pilot randomised controlled clinical trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	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(s)	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.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	01/08/2013

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Years
Upper age limit	15 Years
Sex	All
Target sample size at registration	50
Key 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
Key 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
Date of first enrolment	01/03/2010
Date of final enrolment	01/08/2013

Locations

Countries of recruitment

Canada
United States of America

Study participating centre

Division of Orthopaedic Surgery

Toronto
M5G 1X8
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

11/04/2019: No publications found, verifying study status with principal investigator.