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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 5, 2007 | ||||
| Last Updated Date | January 5, 2007 | ||||
| Start Date ICMJE | January 2007 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
change in Gross Motor Function Measure (GMFM-66) from baseline to 12 months | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Outcomes of Orthopaedic Surgery Using Gait Laboratory Versus Observational Gait Analysis in Children With Cerebral Palsy | ||||
| Official Title ICMJE | Functional Outcomes Following Orthopaedic Surgery Based on Gait Laboratory Versus Observational Gait Analysis in Ambulatory Children With Cerebral Palsy: A Pilot Randomized Controlled Trial. | ||||
| 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. |
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| 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. 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. |
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| Study Phase | Phase I, Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Cerebral Palsy | ||||
| Intervention ICMJE | Procedure: Gait analysis in a motion laboratory | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Enrollment ICMJE | 20 | ||||
| Completion Date | June 2008 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 6 Years to 15 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00419432 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 1000009387 | ||||
| Study Sponsor ICMJE | The Hospital for Sick Children | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | The Hospital for Sick Children | ||||
| Verification Date | January 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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