An In-Shoe Device to Monitor Toe-Walking in Children With Cerebral Palsy
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Children With Cerebral Palsy
- Sponsor
- Spaulding Rehabilitation Hospital
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Toe Walking Severity (TWS) index
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
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.
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.
Investigators
Paolo Bonato
Director, Motion Analysis Laboratory
Spaulding Rehabilitation Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
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 Outcomes
- Edinburgh Visual Scale (EVS) score(1 day)