Load Experienced While Using a Stander in Children With Cerebral Palsy

Study Overview
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Brief Summary
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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.

Detailed Description
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Non-ambulatory children with a neuromuscular disability are at significant risk for poor bone health as reflected by low bone mineral density (BMD) and increased propensity to fracture. In large part, this is due to abnormally low levels of load experienced by the skeleton. A common approach for increasing BMD is to stimulate the musculoskeletal system by increasing the amount and duration of weight-bearing in the lower extremities. For non-ambulatory individuals, this typically takes the form of using an assisted standing device to enable the child to spend time in a standing position so that their lower limbs can experience some degree of body weight. Some of these physical interventions result in varying degrees of improvement in BMD, and some do not. This lack of clarity in outcomes may result from a failure to objectively measure the magnitude and duration of the load experienced by the lower extremities. A lack of change in BMD may be due to the extremities experiencing only a fraction of the body weight due to load-sharing with the assistive device, or to an inadequate duration of standing time. The goal of this project will be 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 BMD.

Official Title
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Load Experienced While Using a Stander in Children With Cerebral Palsy

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Other: Assisted Standing Treatment Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: < 18 years old Diagnosed with Cerebral Palsy (CP) Treated at Gillette Children's Specialty Healthcare Gross Motor Function Classification System level of IV or V (non-ambulatory without assistance) Participating in a standing program using a stationary assisted standing device Parent/Guardian willing and able to give consent Exclusion Criteria: None

Ages Eligible for Study
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Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Force-measuring platform<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cerebral Palsy, Non ambulatory, Neuromuscular disability, Children