Load Experienced While Using a Stander in Children With Cerebral Palsy

Not Applicable

Completed

• Conditions: Cerebral Palsy
• Interventions: Other: Assisted Standing Treatment Program

• Registration Number: NCT01952496
• Lead Sponsor: Gillette Children's Specialty Healthcare

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2013-09-17
• Study First Submitted QC: 2013-09-24
• Study First Posted: 2013-09-30
• Study Start: 2014-02
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-15
• Last Update Posted: 2016-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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

None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Force-measuring platform	Assisted Standing Treatment Program	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.

Primary Outcome Measures

Name	Time	Method
Bone Mineral Density	12 months	Bone Mineral Density will be measured via dual energy x-ray absorptiometry (DXA) and peripheral quantitative computed tomography (pQCT) scans.

Secondary Outcome Measures

Name	Time	Method
Caregiver Priorities & Child Health Index of Life with Disabilities (CPCHILD) questionnaire	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.
Weight (load)experienced by lower extremities	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)	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.

Trial Locations

Locations (2)

Clinical and Translational Science Institute at University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Gillette Children's Specialty Healthcare; 🇺🇸 St. Paul, Minnesota, United States