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

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:

1. Establish the feasibility of implementing the randomized trial study design in multiple
centres

2. Estimate recruitment rates and timelines

3. Establish responsiveness of outcome measures to finalize the primary & secondary
outcomes

4. Estimate effect sizes of functional outcomes for sample size calculations

5. Establish data management system (web-based database) for definitive multi-centre
study.

6. 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:

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- & inter rater
reliability

Inclusion Criteria:

1. Diagnosis of spastic cerebral palsy.

2. Age 6 to 15 years at the time of the initial assessment.

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 &
ankle).

7. Patients must be able to undergo instrumented gait analysis in a motion laboratory.

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.