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

This study has been terminated.
(Lack of funding)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01684254
First Posted: September 12, 2012
Last Update Posted: March 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Peabody Foundation, Inc.
Information provided by (Responsible Party):
Paolo Bonato, Spaulding Rehabilitation Hospital
  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 Paolo Bonato, Spaulding Rehabilitation Hospital:

Primary Outcome Measures:
  • Toe Walking Severity (TWS) index [ Time Frame: 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 Outcome Measures:
  • Edinburgh Visual Scale (EVS) score [ Time Frame: 1 day ]
    Clinical measure of severity of gait deviation


Enrollment: 7
Study Start Date: May 2010
Study Completion Date: December 2016
Primary Completion Date: December 2016 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01684254


Locations
United States, Massachusetts
Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States, 02129
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
Peabody Foundation, Inc.
  More Information

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
First Submitted: September 10, 2012
First Posted: September 12, 2012
Last Update Posted: March 13, 2017
Last Verified: March 2017

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

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