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

NCT ID: NCT01684254

Last Updated: 2017-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

7 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Children With Cerebral Palsy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Children with Cerebral Palsy (CP)

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peabody Foundation, Inc.

OTHER

Sponsor Role collaborator

Spaulding Rehabilitation Hospital

OTHER

Sponsor Role lead

Responsible Party

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Paolo Bonato

Director, Motion Analysis Laboratory

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Spaulding Rehabilitation Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2007-P-000837

Identifier Type: -

Identifier Source: org_study_id

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