Outcomes of Orthopaedic Surgery Using Gait Laboratory Versus Observational Gait Analysis in Children With Cerebral Palsy
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|ClinicalTrials.gov Identifier: NCT00419432|
Recruitment Status : Active, not recruiting
First Posted : January 8, 2007
Last Update Posted : November 17, 2017
|Condition or disease||Intervention/treatment||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|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|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.|
|Study Start Date :||January 2007|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||August 2018|
|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
- General Effect Size of Secondary Outcomes [ Time Frame: Post Study ]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 ]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 ]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 ]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 ]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 ]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 ]Quantifies the magnitude of gait deviation from normal
- Gait Parameters [ Time Frame: Baseline, 12-, 24-months follow-up ]Gait velocity; Stride length; O2 consumption & O2 Cost during walking
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00419432
|Glenrose Rehabilitation Hospital|
|Edmonton, Alberta, Canada|
|Canada, British Columbia|
|British Columbia's Children's Hospital|
|Vancouver, British Columbia, Canada|
|Mississauga, Ontario, Canada, L5L 2M5|
|Grandview Children's Rehabilitation Centre|
|Oshawa, Ontario, Canada, L1H 7K6|
|Bloorview Kids Rehab|
|Toronto, Ontario, Canada, M4G 1R8|
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|
|Principal Investigator:||Unni Narayanan, MBBS, MSc, FRCSC||The Hospital for Sick Children, Toronto Canada|