An In-Shoe Device to Monitor Toe-Walking in Children With Cerebral Palsy
The present project will focus on evaluating the technical efficacy of the in-shoe gait monitoring device (ActiveGait) through laboratory based biomechanical gait assessments of children who exhibit gait deviations due to CP or idiopathic toe walking wearing the device.
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:||May 2015|
|Estimated Primary Completion Date:||November 2014 (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
|Contact: Catherine Adans-Desterfirstname.lastname@example.org|
|Contact: Shyamal Shyamal, PhDemail@example.com|
|United States, Massachusetts|
|Spaulding Rehabilitation Hospital||Recruiting|
|Boston, Massachusetts, United States, 02129|
|Contact: Catherine Adans-Dester 617-952-6321 firstname.lastname@example.org|
|Principal Investigator: Paolo Bonato, PhD|