An In-Shoe Device to Monitor Toe-Walking in Children With Cerebral Palsy
NCT ID: NCT01684254
Last Updated: 2017-03-13
Study Results
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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TERMINATED
7 participants
OBSERVATIONAL
2010-05-31
2016-12-31
Brief Summary
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Detailed Description
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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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Study Design
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COHORT
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 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
5 Years
17 Years
ALL
No
Sponsors
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Peabody Foundation, Inc.
OTHER
Spaulding Rehabilitation Hospital
OTHER
Responsible Party
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Paolo Bonato
Director, Motion Analysis Laboratory
Locations
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Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States
Countries
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Other Identifiers
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2007-P-000837
Identifier Type: -
Identifier Source: org_study_id
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