An In-Shoe Device to Monitor Toe-Walking in Children With Cerebral Palsy
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|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|
|Actual Primary Completion Date :||December 2016|
|Actual 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
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): NCT01684254
|United States, Massachusetts|
|Spaulding Rehabilitation Hospital|
|Boston, Massachusetts, United States, 02129|