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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01684254

Enrollment

Registered

2012-09-12

Start date

2010-05-31

Completion date

2016-12-31

Last updated

2017-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children With Cerebral Palsy

Keywords

Cerebral Palsy, Home monitoring, Gait, Sensorized Shoe

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

5 Years to 17 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Edinburgh Visual Scale (EVS) score	1 day	Clinical measure of severity of gait deviation

Countries

United States

Outcome results