This trial is active, not recruiting.

Condition cerebral palsy
Treatments routine observational analysis (prior to procedure), routine observational analysis supplemented with gait lab information (prior to procedure)
Phase phase 1/phase 2
Sponsor The Hospital for Sick Children
Start date January 2007
End date August 2017
Trial size 60 participants
Trial identifier NCT00419432, 1000009387


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver)
Primary purpose treatment
(Active Comparator)
routine observational analysis (prior to procedure)
Controls will undergo the standard orthopaedic surgery using the information from the physical examination and observational analysis of the gait alone.
routine observational analysis supplemented with gait lab information (prior to procedure)
This experimental group will undergo standard orthopaedic surgery using the information from the physical examination, observational AND the gait laboratory analysis data

Primary Outcomes

General Effect Size of Secondary Outcomes
time frame: Post Study

Secondary Outcomes

Gross Motor Function Measure (GMFM-66)
time frame: Baseline, 6, 12, 24 months follow up
Pediatric Outcomes Data Collection Instrument(PODCI)
time frame: Baseline, 6, 12, 24 months follow up
Gillette Functional Assessment Questionnaire (FAQ)
time frame: Baseline, 6, 12, 24 months follow up
Functional Mobility Scale (FMS)
time frame: Baseline, 6, 12, 24 months follow up
Activity Scale for Kids (ASK)
time frame: Baseline, 6, 12, 24 months follow up
Gillette Gait (Normalcy) Index (GGI)
time frame: Baseline, 6, 12, 24 months follow up
Gait Parameters
time frame: Baseline, 12-, 24-months follow-up

Eligibility Criteria

Male or female participants from 6 years up to 15 years old.

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.

Additional Information

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.
Principal investigator Unni Narayanan, MBBS, MSc, FRCSC
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
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by The Hospital for Sick Children.