Outcomes of Orthopaedic Surgery Using Gait Laboratory Versus Observational Gait Analysis in Children With Cerebral Palsy

Study Overview
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Brief Summary
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The purpose of this pilot trial is to determine whether the addition of gait laboratory analysis for surgical decision making, compared with the use of observational analysis alone, results in improved functional outcomes in ambulatory children with cerebral palsy undergoing multi-level lower extremity orthopaedic surgery.

Detailed Description
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Children with cerebral palsy, who are ambulatory, have an inefficient gait often associated with functional disability. Many of these children are candidates for orthopaedic surgery, which includes multi-level soft tissue and bony procedures. Pre-operative planning is based on the physical examination and visual (observational) analysis of the child's gait. In some centres, patients undergo additional gait analysis in a motion laboratory. While gait laboratory analysis is accepted as an important research tool, there is controversy about its clinical utility in decision making for the surgical management of this population. To date, no clinical trials have been undertaken to answer this question, and the appropriate clinical utilization of this technology is yet to be established. The consequence of this uncertainty is that ambulatory children with cerebral palsy are either being deprived of a useful assessment tool in some centres, or alternatively they are being subjected to an unnecessary evaluation that is both expensive and time consuming in other centres. A multi-centre randomized trial will provide evidence to support or refute the need for gait laboratory analysis for surgical decision-making for this population. This pilot randomized controlled trial in four sites will assess the feasibility of, and provide the template for the design and conduct of the definitive larger multi-centred trial to extend its generalizability across North America and other jurisdictions. The specific objectives include: Establish the feasibility of implementing the randomized trial study design in multiple centres Estimate recruitment rates and timelines Establish responsiveness of outcome measures to finalize the primary & secondary outcomes Estimate effect sizes of functional outcomes for sample size calculations Establish data management system (web-based database) for definitive multi-centre study. Assess feasibility, reliability and face validity of pilot health economic data forms to include health economic evaluation in the future definitive multi-centre trial. Secondary objectives include: Does the addition of gait analysis alter surgical decisions made from video observation alone, when performed in the setting of this pilot trial? Evaluate the consistency of the surgical decision making: intra- & inter rater reliability

Official Title
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Functional Outcomes Following Orthopaedic Surgery Based on Gait Laboratory Versus Observational Gait Analysis in Ambulatory Children With Cerebral Palsy: A Multi-center Randomized Controlled Trial.

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Other: Routine Observational Analysis (prior to procedure)
* Other: Routine Observational analysis supplemented with Gait Lab Information (prior to procedure)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of spastic cerebral palsy. Age 6 to 15 years at the time of the initial assessment. Gross Motor Function Classification System (GMFCS) levels II or III (demonstrable independent ambulatory potential with or without orthotics/assist devices). Patients have been referred for assessment and treatment of gait abnormality. Patients have a gait abnormality interfering with their physical function. 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 & ankle). Patients must be able to undergo instrumented gait analysis in a motion laboratory. Exclusion Criteria: Presence of dystonia, athetosis, or mixed tone abnormalities. History of orthopaedic lower extremity procedures within the previous 2 years. Patients who have had previous gait laboratory analysis that has been seen by the treating surgeon. Patients who will be unable to return for the required follow up visits/gait analysis.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A (standard pre-operative analysis)<br> | Other: Routine Observational Analysis (prior to procedure)<br>* Controls will undergo the standard orthopaedic surgery using the information from the physical examination and observational analysis of the gait alone.<br>|
| Experimental: Group B (additional pre-operative analysis)<br> | Other: Routine Observational analysis supplemented with Gait Lab Information (prior to procedure)<br>* This experimental group will undergo standard orthopaedic surgery using the information from the physical examination, observational AND the gait laboratory analysis data<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General Effect Size of Secondary Outcomes | The final primary and secondary outcome measures will be chosen based on responsiveness and their effect sizes used to calculate sample size for a future definitive trial. | Post Study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gross Motor Function Measure (GMFM-66) | A well validated condition specific clinical measure to evaluate change in motor function in children with cerebral palsy | Baseline, 6, 12, 24 months follow up | 
| Pediatric Outcomes Data Collection Instrument(PODCI) | A generic measure of musculoskeletal functional health outcomes in children and adolescents | Baseline, 6, 12, 24 months follow up | 
| Gillette Functional Assessment Questionnaire (FAQ) | A validated condition specific functional walking scale developed for children with cerebral palsy | Baseline, 6, 12, 24 months follow up | 
| Functional Mobility Scale (FMS) | Developed to measure functional mobility of a child in three different environments (home, school, and the wider community). | Baseline, 6, 12, 24 months follow up | 
| Activity Scale for Kids (ASK) | A reliable and valid, self-report measure of childhood physical disability. | Baseline, 6, 12, 24 months follow up | 
| Gillette Gait (Normalcy) Index (GGI) | Quantifies the magnitude of gait deviation from normal | Baseline, 6, 12, 24 months follow up | 
| Gait Parameters | Gait velocity; Stride length; O2 consumption & O2 Cost during walking | Baseline, 12-, 24-months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatrics, Cerebral Palsy, Gait Analysis, Orthopedic Surgery