Outcomes of Orthopaedic Surgery Using Gait Laboratory Versus Observational Gait Analysis in Children With Cerebral Palsy - Full Text View

Sponsor:	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	Other: Routine Observational Analysis (prior to procedure) Other: Routine Observational analysis supplemented with Gait Lab Information (prior to procedure)	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Cerebral Palsy Paralysis

U.S. FDA Resources

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

Primary Outcome Measures:

General Effect Size of Secondary Outcomes [ Time Frame: Post Study ] [ Designated as safety issue: No ]
The final primary and secondary outcome measures will be chosen based on responsiveness and their effect sizes used to calculate sample size for a future definitive trial.

Secondary Outcome Measures:

Gross Motor Function Measure (GMFM-66) [ Time Frame: Baseline, 6, 12, 24 months follow up ] [ Designated as safety issue: No ]
A well validated condition specific clinical measure to evaluate change in motor function in children with cerebral palsy
Pediatric Outcomes Data Collection Instrument(PODCI) [ Time Frame: Baseline, 6, 12, 24 months follow up ] [ Designated as safety issue: No ]
A generic measure of musculoskeletal functional health outcomes in children and adolescents
Gillette Functional Assessment Questionnaire (FAQ) [ Time Frame: Baseline, 6, 12, 24 months follow up ] [ Designated as safety issue: No ]
A validated condition specific functional walking scale developed for children with cerebral palsy
Functional Mobility Scale (FMS) [ Time Frame: Baseline, 6, 12, 24 months follow up ] [ Designated as safety issue: No ]
Developed to measure functional mobility of a child in three different environments (home, school, and the wider community).
Activity Scale for Kids (ASK) [ Time Frame: Baseline, 6, 12, 24 months follow up ] [ Designated as safety issue: No ]
A reliable and valid, self-report measure of childhood physical disability.
Gillette Gait (Normalcy) Index (GGI) [ Time Frame: Baseline, 6, 12, 24 months follow up ] [ Designated as safety issue: No ]
Quantifies the magnitude of gait deviation from normal
Gait Parameters [ Time Frame: Baseline, 12-, 24-months follow-up ] [ Designated as safety issue: No ]
Gait velocity; Stride length; O2 consumption & O2 Cost during walking

Estimated Enrollment:	50
Study Start Date:	January 2007
Estimated Study Completion Date:	October 2014
Estimated Primary Completion Date:	October 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Group A (standard pre-operative analysis)	Other: 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.
Experimental: Group B (additional pre-operative analysis)	Other: 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

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. 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:

Establish the feasibility of implementing the randomized trial study design in multiple centres
Estimate recruitment rates and timelines
Establish responsiveness of outcome measures to finalize the primary & secondary outcomes
Estimate effect sizes of functional outcomes for sample size calculations
Establish data management system (web-based database) for definitive multi-centre study.
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:
Does the addition of gait analysis alter surgical decisions made from video observation alone, when performed in the setting of this pilot trial?
Evaluate the consistency of the surgical decision making: intra- & inter rater reliability

Eligibility

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

Criteria

Inclusion Criteria:

Diagnosis of spastic cerebral palsy.
Age 6 to 15 years at the time of the initial assessment.
Gross Motor Function Classification System (GMFCS) levels II or III (demonstrable independent ambulatory potential with or without orthotics/assist devices).
Patients have been referred for assessment and treatment of gait abnormality.
Patients have a gait abnormality interfering with their physical function.
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).
Patients must be able to undergo instrumented gait analysis in a motion laboratory.

Exclusion Criteria:

Presence of dystonia, athetosis, or mixed tone abnormalities.
History of orthopaedic lower extremity procedures within the previous 2 years.
Patients who have had previous gait laboratory analysis that has been seen by the treating surgeon.
Patients who will be unable to return for the required follow up visits/gait analysis.

Contacts and Locations

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

Contacts

Contact: Unni Narayanan, MBBS, MSc, FRCSC

416-813-6432

unni.narayanan@sickkids.ca

Locations

United States, Wisconsin
University of Wisconsin-Madison	Active, not recruiting
Madison, Wisconsin, United States
Canada, Alberta
Glenrose Rehabilitation Hospital	Active, not recruiting
Edmonton, Alberta, Canada
Canada, British Columbia
British Columbia's Children's Hospital	Active, not recruiting
Vancouver, British Columbia, Canada
Canada, Ontario
Erinoak Centre	Recruiting
Mississauga, Ontario, Canada, L5L 2M5
Grandview Children's Rehabilitation Centre	Recruiting
Oshawa, Ontario, Canada, L1H 7K6
Bloorview Kids Rehab	Recruiting
Toronto, Ontario, Canada, M4G 1R8
Contact: Darcy L. Fehlings, MD, MSc, FRCPC 416-425-6220 ext 3586 darcy.fehlings@bloorviewmacmillan.on.ca
Principal Investigator: Darcy L. Fehlings, MD
Sub-Investigator: Susan Redekop, BASc
The Hospital for Sick Children	Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Unni Narayanan, MD 416 813 6432 unni.narayanan@sickkids.ca
Contact: Shannon Weir, BSc, MSc 416-813-6608 shannon.weir@sickkids.ca
Principal Investigator: Unni G Narayanan, MBBS, MSc, FRCSC
Sub-Investigator: John Wedge, MD
Sub-Investigator: Andrew R Willan, PhD

Sponsors and Collaborators

The Hospital for Sick Children

Investigators

Principal Investigator:

Unni Narayanan, MBBS, MSc, FRCSC

The Hospital for Sick Children, Toronto Canada

More Information

No publications provided

Responsible Party:	Unni G Narayanan, Principal Investigator, The Hospital for Sick Children
ClinicalTrials.gov Identifier:	NCT00419432 History of Changes
Other Study ID Numbers:	1000009387
Study First Received:	January 5, 2007
Last Updated:	March 26, 2010
Health Authority:	Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:

Pediatrics
Cerebral Palsy
Gait Analysis
Orthopedic Surgery

Additional relevant MeSH terms:

Cerebral Palsy
Paralysis
Brain Damage, Chronic
Brain Diseases

Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on February 12, 2012