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NCT02341053 · ClinicalTrials.gov registry record · NA
Effects of Standing on Non-Ambulatory Children With Spinal Muscular Atrophy
A NA study of Spinal Muscular Dystrophy and Neuromuscular Disability, sponsored by Gillette Children's Specialty Healthcare.
- Completed
- Registry status
- NA
- Development phase
- 4
- Enrollment target
- 1
- Study location
NCT02341053 is a NA study of Spinal Muscular Dystrophy and Neuromuscular Disability that has completed, run by Gillette Children's Specialty Healthcare. The registered enrollment target is 4 participants. The trial reports 1 study location across 1 state.
The verdict
NCT02341053, a NA study of Spinal Muscular Dystrophy and Neuromuscular Disability, has completed, sponsored by Gillette Children's Specialty Healthcare.
- COMPLETED
- Registry status
- NA
- Development phase
- 4 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- OTHER Assisted Standing Treatment Program
Study Locations (1)
Minnesota
- Gillette Children's Specialty Healthcare - Saint Paul
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2016-09-08 |
| Est. Completion | 2018-07-25 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02341053
The ClinicalTrials.gov registry entry for NCT02341053 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gillette Children's Specialty Healthcare, which has 12 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Spinal Muscular Dystrophy appearing as the primary indexed condition, and to 1 intervention - of which Assisted Standing Treatment Program is the first listed.
NCT02341053 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT02341053 about?
NCT02341053 is a clinical study titled "Effects of Standing on Non-Ambulatory Children With Spinal Muscular Atrophy". 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...
What is the current status of trial NCT02341053?
This trial is currently completed. It is a NA study. The enrollment target is 4 participants. The study started on 2016-09-08. Estimated completion is 2018-07-25.
What conditions does trial NCT02341053 study?
This clinical trial studies the following conditions: Spinal Muscular Dystrophy, Neuromuscular Disability.
What interventions are being tested in trial NCT02341053?
The interventions under investigation include: Assisted Standing Treatment Program (OTHER).
Who is sponsoring clinical trial NCT02341053?
This trial is sponsored by Gillette Children's Specialty Healthcare, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02341053 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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