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Completed

NCT Number: NCT01952496

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.

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Key information

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Assisted Standing Treatment Program

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Gillette Children's Specialty Healthcare

Other

Collaborators

  • University of Minnesota

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 30, 2013
Registry last updated
Feb 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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