An In-Shoe Device to Monitor Toe-Walking in Children With Cerebral Palsy

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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. Tasks include: 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.

Official Title
-----------------
An In-Shoe Device to Monitor Toe-Walking in Children With Cerebral Palsy

Conditions
-----------------
Children With Cerebral Palsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: able to ambulate 50 feet on level ground without the assistance of a person able to ambulate on ramps and stairs without the assistance of a person demonstrate a toe-walking pattern at the time of enrollment medically stable able to understand directions and follow simple instructions Exclusion Criteria: any cardiopulmonary, orthopedic, and neurological conditions other than CP that would prevent them from performing the motor tasks of interest

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children with Cerebral Palsy (CP)<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toe Walking Severity (TWS) index | Measure for quantifying changes in severity of toe walking over time based on Center of Pressure trajectories computed by the sensorized insole | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Edinburgh Visual Scale (EVS) score | Clinical measure of severity of gait deviation | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cerebral Palsy, Home monitoring, Gait, Sensorized Shoe