Study Stopped
Lack of funding
An In-Shoe Device to Monitor Toe-Walking in Children With Cerebral Palsy
1 other identifier
observational
7
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2010
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 10, 2012
CompletedFirst Posted
Study publicly available on registry
September 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedMarch 13, 2017
March 1, 2017
6.6 years
September 10, 2012
March 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Toe Walking Severity (TWS) index
Measure for quantifying changes in severity of toe walking over time based on Center of Pressure trajectories computed by the sensorized insole
1 day
Secondary Outcomes (1)
Edinburgh Visual Scale (EVS) score
1 day
Study Arms (1)
Children with Cerebral Palsy (CP)
Eligibility Criteria
Children diagnosed with CP
You may qualify if:
- 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
You may not qualify if:
- any cardiopulmonary, orthopedic, and neurological conditions other than CP that would prevent them from performing the motor tasks of interest
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Spaulding Rehabilitation Hospitallead
- Peabody Foundation, Inc.collaborator
Study Sites (1)
Spaulding Rehabilitation Hospital
Boston, Massachusetts, 02129, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Motion Analysis Laboratory
Study Record Dates
First Submitted
September 10, 2012
First Posted
September 12, 2012
Study Start
May 1, 2010
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
March 13, 2017
Record last verified: 2017-03