Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00419432
Status:
UNKNOWN
Last Update Posted:
2021-02-10
First Post:
2007-01-05
Brief Title:
Outcomes of Orthopaedic Surgery Using Gait Laboratory Versus Observational Gait Analysis in Children With Cerebral Palsy
Sponsor:
The Hospital for Sick Children
Organization:
The Hospital for Sick Children
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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 childs 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
1 Establish the feasibility of implementing the randomized trial study design in multiple centres
2 Estimate recruitment rates and timelines
3 Establish responsiveness of outcome measures to finalize the primary secondary outcomes
4 Estimate effect sizes of functional outcomes for sample size calculations
5 Establish data management system web-based database for definitive multi-centre study
6 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
7 Does the addition of gait analysis alter surgical decisions made from video observation alone when performed in the setting of this pilot trial
8 Evaluate the consistency of the surgical decision making intra- inter rater reliability
1 Establish the feasibility of implementing the randomized trial study design in multiple centres
2 Estimate recruitment rates and timelines
3 Establish responsiveness of outcome measures to finalize the primary secondary outcomes
4 Estimate effect sizes of functional outcomes for sample size calculations
5 Establish data management system web-based database for definitive multi-centre study
6 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
7 Does the addition of gait analysis alter surgical decisions made from video observation alone when performed in the setting of this pilot trial
8 Evaluate the consistency of the surgical decision making intra- inter rater reliability
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None