Cerebral Palsy Clinical Trial
Official title:
Load Experienced While Using a Stander in Children With Cerebral Palsy
The goal of this project is to design and validate a force-measuring platform that will measure the magnitude and duration of the load experienced by the lower extremities of individuals with a neuromuscular disability who use a stationary assisted standing device to increase their Bone Mineral Density.
Status | Completed |
Enrollment | 3 |
Est. completion date | September 2015 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 17 Years |
Eligibility |
Inclusion Criteria: 1. < 18 years old 2. Diagnosed with Cerebral Palsy (CP) 3. Treated at Gillette Children's Specialty Healthcare 4. Gross Motor Function Classification System level of IV or V (non-ambulatory without assistance) 5. Participating in a standing program using a stationary assisted standing device 6. Parent/Guardian willing and able to give consent Exclusion Criteria: |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Clinical and Translational Science Institute at University of Minnesota | Minneapolis | Minnesota |
United States | Gillette Children's Specialty Healthcare | St. Paul | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Gillette Children's Specialty Healthcare | University of Minnesota - Clinical and Translational Science Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bone Mineral Density | Bone Mineral Density will be measured via dual energy x-ray absorptiometry (DXA) and peripheral quantitative computed tomography (pQCT) scans. | 12 months | No |
Secondary | Weight (load)experienced by lower extremities | A platform will measure the magnitude of the load experienced by the lower extremities of individuals with a neuromuscular disability who use a stationary assisted standing device to increase their Bone Mineral Density. | 12 months | No |
Secondary | Duration of standing treatment session(s) (time) | A platform will measure the duration of the load experienced by the lower extremities of individuals with a neuromuscular disability who use a stationary assisted standing device to increase their Bone Mineral Density. | 12 months | No |
Secondary | Caregiver Priorities & Child Health Index of Life with Disabilities (CPCHILD) questionnaire | The CPCHILD© measures caregivers' perspectives on the health status, comfort, well being, functional abilities and ease of caregiving of children with severe developmental disabilities. It was developed to measure the effectiveness of interventions intended to improve or preserve these outcomes for children with severe disabilities, including non-ambulant children with severe cerebral palsy, and traumatic or other acquired brain injuries. This will help determine if care-givers perception of health status changes with changes in standing magnitude and duration. | 12 months | No |
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