Outcomes of Orthopaedic Surgery Using Gait Laboratory Versus Observational Gait Analysis in Children With Cerebral Palsy
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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 1 Phase 2 |
| 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. |
- 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.
- 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 |
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| Contact: Unni Narayanan, MBBS, MSc, FRCSC | 416-813-6432 | unni.narayanan@sickkids.ca |
| 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 | |
| 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 May 19, 2013