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| Sponsored by: |
The Hospital for Sick Children |
|---|---|
| Information provided by: | The Hospital for Sick Children |
| ClinicalTrials.gov Identifier: | NCT00419432 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cerebral Palsy |
Procedure: Gait analysis in a motion laboratory |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Functional Outcomes Following Orthopaedic Surgery Based on Gait Laboratory Versus Observational Gait Analysis in Ambulatory Children With Cerebral Palsy: A Pilot Randomized Controlled Trial. |
| Estimated Enrollment: | 20 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | June 2008 |
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.
Eligibility| Ages Eligible for Study: | 6 Years to 15 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Unni Narayanan, MD | 416-813-6432 | unni.narayanan@sickkids.ca |
| Canada, Ontario | |
| The Hospital for Sick Children | Recruiting |
| Toronto, Ontario, Canada, M5G 1X8 | |
| Contact: Unni Narayanan, MD 416 813 6432 unni.narayanan@sickkids.ca | |
| Principal Investigator: Unni G Narayanan, MD | |
| Sub-Investigator: John Wedge, MD | |
| Sub-Investigator: Andrew R Willan, PhD | |
| Bloorview MacMillan Children’s Centre | Recruiting |
| Toronto, Ontario, Canada, M4G 1R8 | |
| Contact: Darcy L. Fehlings, MD 416-425-6220 ext 3586 dfehlings@bloorviewmacmillan.on.ca | |
| Principal Investigator: Darcy L. Fehlings, MD | |
| Sub-Investigator: Alan Morris, MASc | |
| Sub-Investigator: Susan Redekop, BASc | |
| Erinoak Centre | Recruiting |
| Mississauga, Ontario, Canada, L5L 2M5 | |
| Grandview Children's Rehabilitation Centre | Recruiting |
| Oshawa, Ontario, Canada, L1H 7K6 | |
| Principal Investigator: | Unni Narayanan, MD | The Hospital for Sick Children, Toronto Canada |
More Information
| Study ID Numbers: | 1000009387 |
| Study First Received: | January 5, 2007 |
| Last Updated: | January 5, 2007 |
| ClinicalTrials.gov Identifier: | NCT00419432 History of Changes |
| Health Authority: | Canada: Ethics Review Committee |
|
Pediatrics Cerebral Palsy Gait Analysis Orthopedic Surgery |
|
Paralysis Cerebral Palsy Brain Damage, Chronic |
Central Nervous System Diseases Brain Diseases Brain Injuries |
|
Cerebral Palsy Nervous System Diseases Brain Damage, Chronic Central Nervous System Diseases Brain Diseases |