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Load Experienced While Using a Stander in Children With Cerebral Palsy

Load Experienced While Using a Stander in Children With Cerebral Palsy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01952496
Enrollment
3
Registered
2013-09-30
Start date
2014-02-28
Completion date
2015-09-30
Last updated
2016-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy

Keywords

Cerebral Palsy, Non ambulatory, Neuromuscular disability, Children

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.

Interventions

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

Sponsors

University of Minnesota
CollaboratorOTHER
Gillette Children's Specialty Healthcare
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Bone Mineral Density12 monthsBone Mineral Density will be measured via dual energy x-ray absorptiometry (DXA) and peripheral quantitative computed tomography (pQCT) scans.

Secondary

MeasureTime frameDescription
Weight (load)experienced by lower extremities12 monthsA 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 monthsA 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) questionnaire12 monthsThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026