An In-Shoe Device to Monitor Toe-Walking in Children With Cerebral Palsy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Toe Walking Severity (TWS) index
Study 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 5 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Investigators
Paolo Bonato
Director, Motion Analysis Laboratory
Spaulding Rehabilitation Hospital