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

Children With Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01684254
• Other study ID #: 2007-P-000837
• Status: Terminated
• Phase: N/A
• First received: September 10, 2012
• Last updated: March 9, 2017
• Start date: May 2010
• Est. completion date: December 2016

Study information

• Verified date: March 2017
• Source: Spaulding Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Children With Cerebral Palsy
• Paralysis

Locations

Country	Name	City	State
United States	Spaulding Rehabilitation Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Spaulding Rehabilitation Hospital	Peabody Foundation, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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