An In-Shoe Device to Monitor Toe-Walking in Children With Cerebral Palsy
|ClinicalTrials.gov Identifier: NCT01684254|
Recruitment Status : Terminated (Lack of funding)
First Posted : September 12, 2012
Last Update Posted : March 13, 2017
|Condition or disease|
|Children With Cerebral Palsy|
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.
|Study Type :||Observational|
|Actual Enrollment :||7 participants|
|Official Title:||An In-Shoe Device to Monitor Toe-Walking in Children With Cerebral Palsy|
|Study Start Date :||May 2010|
|Primary Completion Date :||December 2016|
|Study Completion Date :||December 2016|
|Children with Cerebral Palsy (CP)|
- Toe Walking Severity (TWS) index [ Time Frame: 1 day ]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 ]Clinical measure of severity of gait deviation
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01684254
|United States, Massachusetts|
|Spaulding Rehabilitation Hospital|
|Boston, Massachusetts, United States, 02129|