Effects of Standing on Non-Ambulatory Children With Spinal Muscular Atrophy
Completed · Not applicable
Conditions studied: Spinal Muscular Dystrophy, Neuromuscular Disability
In brief
Non-ambulatory children with a neuromuscular disability such as spinal muscular atrophy (SMA) are at significant risk for poor bone health as defined by low bone mineral density (BMD) and increased propensity to fracture. Poor bone health is thought to be related, at least in part, to abnormally low levels of load experienced by the skeleton. A common physical approach for increasing bone density is to stimulate the musculoskeletal system by increasing the amount and duration of weight-bearing in the lower extremities. For non-ambulatory individuals, this takes the form of using an assisted standing device to enable the child to spend time in a standing position with some degree of weight placed on the lower limbs. Some of these physical interventions demonstrate variable improvement in BMD in children with neuromuscular conditions, and some do not. A serious limitation in the previous work in this area is a failure to objectively measure the magnitude and duration of the loading experienced by the lower extremities. Thus, 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) for an inadequate duration of standing time. In order to investigate the efficacy of standing treatment for increasing BMD, the investigators will develop a simple, portable and inexpensive transducer that will measure the magnitude and time course of the load experienced by the lower extremities of individuals with SMA who use a stationary assisted standing device. The specific goal of this proposed project will be to develop, validate and establish the initial feasibility of such a measurement device.
Key facts
- Study ID
- NCT02341053
- Run by
- Gillette Children's Specialty Healthcare
- People needed
- 4
- Starts
- 2016-09-08
- Expected to finish
- 2018-07-25
- Last updated by the study team
- 2021-02-17
Who can join
Age: 3 and older, up to 14. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 3-14 years old
- Diagnosed with Spinal Muscular Atrophy (SMA)
- Participating in a standing program using a stationary assisted standing device.
- Gross Motor Function Classification System (GMFCS) Level IV or V
- Parent must be able to provide consent.
You may not qualify if…
- Currently on bisphosphonates
Where it is running
- Gillette Children's Specialty Healthcare — Saint Paul, Minnesota, United States
Full record on ClinicalTrials.gov
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