An In-Shoe Device to Monitor Toe-Walking in Children With Cerebral Palsy
Children With Cerebral Palsy
|Study Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Official Title:||An In-Shoe Device to Monitor Toe-Walking in Children With Cerebral Palsy|
- Toe Walking Severity (TWS) index [ Time Frame: 1 day ] [ Designated as safety issue: No ]Measure for quantifying changes in severity of toe walking over time based on Center of Pressure trajectories computed by the sensorized insole
- Edinburgh Visual Scale (EVS) score [ Time Frame: 1 day ] [ Designated as safety issue: No ]Clinical measure of severity of gait deviation
|Study Start Date:||May 2010|
|Estimated Study Completion Date:||March 2018|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
|Children with Cerebral Palsy (CP)|
The investigators on this protocol intend to develop the device and rely on it to propose a Toe Walk Severity (TWS) index, a novel outcome measure for quantifying changes in severity of toe walking over time and for assessing the outcome of surgical and non-surgical interventions.
A.Validate data acquisition measurements in laboratory setting compared to gold-standard video analysis and field (outside of laboratory).
B.Develop multi-stage classification algorithm from subset of laboratory and field data.
C.Validate classification algorithm against random subsets of laboratory and field data.
D.Explore the development of a Toe Walking Severity (TWS) index from available biomechanical and ActiveGait data for different ambulatory conditions.
E.Perform longitudinal study of the childhood toe walking population including both laboratory analysis and at-home monitoring using ActiveGait technology.
F.Analyze statistically the sensitivity and specificity of the TWS index compared to clinical observations. Gather evidence that the TWS index provides a means to track changes in severity of toe walking over time.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01684254
|United States, Massachusetts|
|Spaulding Rehabilitation Hospital|
|Boston, Massachusetts, United States, 02129|