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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.
Verified by The Hospital for Sick Children, January 2007
First Received: January 5, 2007   No Changes Posted
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.


Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • change in Gross Motor Function Measure (GMFM-66) from baseline to 12 months

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 20
Study Start Date: January 2007
Estimated Study Completion Date: June 2008
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.

  Eligibility

Ages Eligible for Study:   6 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00419432

Contacts
Contact: Unni Narayanan, MD 416-813-6432 unni.narayanan@sickkids.ca

Locations
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
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Unni Narayanan, MD The Hospital for Sick Children, Toronto Canada
  More Information

No publications provided

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

Keywords provided by The Hospital for Sick Children:
Pediatrics
Cerebral Palsy
Gait Analysis
Orthopedic Surgery

Study placed in the following topic categories:
Paralysis
Cerebral Palsy
Brain Damage, Chronic
Central Nervous System Diseases
Brain Diseases
Brain Injuries

Additional relevant MeSH terms:
Cerebral Palsy
Nervous System Diseases
Brain Damage, Chronic
Central Nervous System Diseases
Brain Diseases

ClinicalTrials.gov processed this record on July 02, 2009