An In-Shoe Device to Monitor Toe-Walking in Children With Cerebral Palsy
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition |
|---|
|
Children With Cerebral Palsy |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Cross-Sectional |
| Official Title: | An In-Shoe Device to Monitor Toe-Walking in Children With Cerebral Palsy |
- Toe Walking Severity (TWS) index [ Time Frame: 1 day ] [ Designated as safety issue: No ]Measure for quantifying changes in severity of toe walking over time based on Center of Pressure trajectories computed by the sensorized insole
- Edinburgh Visual Scale (EVS) score [ Time Frame: 1 day ] [ Designated as safety issue: No ]Clinical measure of severity of gait deviation
| Estimated Enrollment: | 45 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Children with Cerebral Palsy (CP) |
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.
Eligibility| Ages Eligible for Study: | 5 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Children diagnosed with CP
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
Contacts and Locations| Contact: Chiara Mancinelli, MS | 617-952-6336 | cmancinelli@partners.org |
| Contact: Catherine Adans-Dester, BS | 617-952-6321 | cadans-dester@partners.org |
| United States, Massachusetts | |
| Spaulding Rehabilitation Hospital | Recruiting |
| Boston, Massachusetts, United States, 02129 | |
| Contact: Chiara Mancinelli, MS 617-952-6336 cmancinelli@partners.org | |
| Principal Investigator: Paolo Bonato, PhD | |
More Information
No publications provided
| Responsible Party: | Paolo Bonato, Director, Motion Analysis Laboratory, Spaulding Rehabilitation Hospital |
| ClinicalTrials.gov Identifier: | NCT01684254 History of Changes |
| Other Study ID Numbers: | 2007-P-000837 |
| Study First Received: | September 10, 2012 |
| Last Updated: | May 1, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Spaulding Rehabilitation Hospital:
|
Cerebral Palsy Home monitoring Gait Sensorized Shoe |
Additional relevant MeSH terms:
|
Cerebral Palsy Paralysis Brain Damage, Chronic Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013