Clinical trial NCT00419432: Outcomes of Orthopaedic Surgery Using Gait Laboratory Versus Observational Gait Analysis in Children With Cerebral Palsy
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy
Keywords: Pediatrics
Cerebral Palsy
Gait Analysis
Orthopedic Surgery
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2007-01-08
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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

Eligibility criteria: 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.

Primary outcomes:
measure: General Effect Size of Secondary Outcomes
timeFrame: Post Study
Secondary outcomes:
measure: Gross Motor Function Measure (GMFM-66)
timeFrame: Baseline, 6, 12, 24 months follow up
measure: Pediatric Outcomes Data Collection Instrument(PODCI)
timeFrame: Baseline, 6, 12, 24 months follow up
measure: Gillette Functional Assessment Questionnaire (FAQ)
timeFrame: Baseline, 6, 12, 24 months follow up
measure: Functional Mobility Scale (FMS)
timeFrame: Baseline, 6, 12, 24 months follow up
measure: Activity Scale for Kids (ASK)
timeFrame: Baseline, 6, 12, 24 months follow up
measure: Gillette Gait (Normalcy) Index (GGI)
timeFrame: Baseline, 6, 12, 24 months follow up
measure: Gait Parameters
timeFrame: Baseline, 12-, 24-months follow-up
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Glenrose Rehabilitation Hospital
state: Alberta
city: Vancouver
country: Canada
facility: British Columbia's Children's Hospital
state: British Columbia
city: Mississauga
country: Canada
facility: Erinoak Centre
state: Ontario
city: Oshawa
country: Canada
facility: Grandview Children's Rehabilitation Centre
state: Ontario
city: Toronto
country: Canada
facility: Bloorview Kids Rehab
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto Canada
name: Unni Narayanan, MBBS, MSc, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: