Load Experienced While Using a Stander in Children With Cerebral Palsy
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|ClinicalTrials.gov Identifier: NCT01952496|
Recruitment Status : Completed
First Posted : September 30, 2013
Last Update Posted : February 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Palsy||Other: Assisted Standing Treatment Program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Load Experienced While Using a Stander in Children With Cerebral Palsy|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2015|
A force-measure platform will be placed under each foot of the subject to record the time course of load borne by each of the lower extremities during weight-bearing training in an assisted standing device.
Intervention: Assisted Standing Treatment Program. Assisted standing treatment program will include at least 2 hours a day, 5 days a week (a total of at least 10 hours a week) for a period of ~9 months.
Other: Assisted Standing Treatment Program
Assisted standing treatment program will include at least 2 hours a day, 5 days a week (a total of at least 10 hours a week) for a period of ~9 months.
Arm: Force-measuring platform
- Bone Mineral Density [ Time Frame: 12 months ]Bone Mineral Density will be measured via dual energy x-ray absorptiometry (DXA) and peripheral quantitative computed tomography (pQCT) scans.
- Weight (load)experienced by lower extremities [ Time Frame: 12 months ]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.
- Duration of standing treatment session(s) (time) [ Time Frame: 12 months ]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.
- Caregiver Priorities & Child Health Index of Life with Disabilities (CPCHILD) questionnaire [ Time Frame: 12 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01952496
|United States, Minnesota|
|Clinical and Translational Science Institute at University of Minnesota|
|Minneapolis, Minnesota, United States, 55414|
|Gillette Children's Specialty Healthcare|
|St. Paul, Minnesota, United States, 55101|
|Principal Investigator:||Walter Truong, MD||Gillette Children's Specialty Healthcare|