Clinical Trials Directory

Trials / Completed

CompletedNCT01952496

Load Experienced While Using a Stander in Children With Cerebral Palsy

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
3 (actual)
Sponsor
Gillette Children's Specialty Healthcare · Academic / Other
Sex
All
Age
17 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERAssisted Standing Treatment ProgramAssisted 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

Timeline

Start date
2014-02-01
Primary completion
2015-09-01
Completion
2015-09-01
First posted
2013-09-30
Last updated
2016-02-17

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01952496. Inclusion in this directory is not an endorsement.