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

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. Identifier: NCT01684254
Recruitment Status : Terminated (Lack of funding)
First Posted : September 12, 2012
Last Update Posted : March 13, 2017
Peabody Foundation, Inc.
Information provided by (Responsible Party):
Paolo Bonato, Spaulding Rehabilitation Hospital

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.

Condition or disease
Children With Cerebral Palsy

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.

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Study Type : Observational
Actual Enrollment : 7 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: An In-Shoe Device to Monitor Toe-Walking in Children With Cerebral Palsy
Study Start Date : May 2010
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Children with Cerebral Palsy (CP)

Primary Outcome Measures :
  1. 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 :
  1. Edinburgh Visual Scale (EVS) score [ Time Frame: 1 day ]
    Clinical measure of severity of gait deviation

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

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

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 identifier (NCT number): NCT01684254

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

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Responsible Party: Paolo Bonato, Director, Motion Analysis Laboratory, Spaulding Rehabilitation Hospital Identifier: NCT01684254    
Other Study ID Numbers: 2007-P-000837
First Posted: September 12, 2012    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: March 2017
Keywords provided by Paolo Bonato, Spaulding Rehabilitation Hospital:
Cerebral Palsy
Home monitoring
Sensorized Shoe
Additional relevant MeSH terms:
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Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases