NCT01684254

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 7 (actual)
• Sponsor: Spaulding Rehabilitation Hospital · Academic / Other
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Children With Cerebral Palsy

Timeline

• Start date: 2010-05-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2012-09-12
• Last updated: 2017-03-13

Locations

1 site across 1 country: United States