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Outcomes of Orthopaedic Surgery Using Gait Laboratory Versus Observational Gait Analysis in Children With Cerebral Palsy
This study is currently recruiting participants.
Study NCT00419432   Information provided by The Hospital for Sick Children
First Received: January 5, 2007   No Changes Posted

January 5, 2007
January 5, 2007
January 2007
 
change in Gross Motor Function Measure (GMFM-66) from baseline to 12 months
Same as current
No Changes Posted
  • change in each of these measures, from baseline to 12 months:
  • Pediatric Outcomes Data Collection Instrument(PODCI)
  • the Gillette Functional Assessment Questionnaire (FAQ)
  • the Functional Mobility Scale (FMS)
  • the Activity Scale for Kids (ASK)
  • the Normalcy Index (quantifies the magnitude of gait deviation from normal)
  • O2 consumption and O2 Cost during walking
  • Gait velocity
  • Stride length
Same as current
 
Outcomes of Orthopaedic Surgery Using Gait Laboratory Versus Observational Gait Analysis in Children With Cerebral Palsy
Functional Outcomes Following Orthopaedic Surgery Based on Gait Laboratory Versus Observational Gait Analysis in Ambulatory Children With Cerebral Palsy: A Pilot Randomized Controlled Trial.

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.

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. This pilot trial will assess the feasibility of a larger trial 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.

Phase I, Phase II
Interventional
Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Cerebral Palsy
Procedure: Gait analysis in a motion laboratory
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
20
June 2008
 

Inclusion Criteria:

  • Ambulatory children with a diagnosis of spastic cerebral palsy
  • Candidates for multi-level lower extremity orthopaedic procedures including soft tissue and/or bony procedures involving at least 2 levels, in one or both lower extremities

Exclusion Criteria:

  • Dystonia
  • Athetosis
  • Mixed tone abnormalities
  • A history of orthopaedic procedures within the previous 2 years
  • Had previous gait analysis
Both
6 Years to 15 Years
No
Contact: Unni Narayanan, MD 416-813-6432 unni.narayanan@sickkids.ca
Canada
 
NCT00419432
 
1000009387
The Hospital for Sick Children
 
Principal Investigator: Unni Narayanan, MD The Hospital for Sick Children, Toronto Canada
The Hospital for Sick Children
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP