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

This study is currently recruiting participants.
Verified March 2014 by Spaulding Rehabilitation Hospital
Sponsor:
Collaborator:
THE PEABODY FOUNDATION INC.
Information provided by (Responsible Party):
Paolo Bonato, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT01684254
First received: September 10, 2012
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

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.


Condition
Children With Cerebral Palsy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: An In-Shoe Device to Monitor Toe-Walking in Children With Cerebral Palsy

Resource links provided by NLM:


Further study details as provided by Spaulding Rehabilitation Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Edinburgh Visual Scale (EVS) score [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Clinical measure of severity of gait deviation


Estimated Enrollment: 45
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)
Groups/Cohorts
Children with Cerebral Palsy (CP)

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.

  Eligibility

Ages Eligible for Study:   5 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Children diagnosed with CP

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01684254

Contacts
Contact: Catherine Adans-Dester 617-952-6321 cadans-dester@partners.org
Contact: Shyamal Shyamal, PhD 617-952-6332 spatel19@partners.org

Locations
United States, Massachusetts
Spaulding Rehabilitation Hospital Recruiting
Boston, Massachusetts, United States, 02129
Contact: Catherine Adans-Dester    617-952-6321    cadans-dester@partners.org   
Principal Investigator: Paolo Bonato, PhD         
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
THE PEABODY FOUNDATION INC.
  More Information

No publications provided

Responsible Party: Paolo Bonato, Director, Motion Analysis Laboratory, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT01684254     History of Changes
Other Study ID Numbers: 2007-P-000837
Study First Received: September 10, 2012
Last Updated: March 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Spaulding Rehabilitation Hospital:
Cerebral Palsy
Home monitoring
Gait
Sensorized Shoe

Additional relevant MeSH terms:
Cerebral Palsy
Paralysis
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 15, 2014