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NCT02428673 · ClinicalTrials.gov registry record · NA
Effects of Standing on Non-Ambulatory Children With Neuromuscular Conditions
A NA study, sponsored by Gillette Children's Specialty Healthcare.
- Completed
- Registry status
- NA
- Development phase
- 6
- Enrollment target
NCT02428673: Completed NA study, sponsored by Gillette Children's Specialty Healthcare.
NCT02428673 is a NA study that has completed, run by Gillette Children's Specialty Healthcare. The registered enrollment target is 6 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02428673, a NA study, has completed, sponsored by Gillette Children's Specialty Healthcare.
- COMPLETED
- Registry status
- NA
- Development phase
- 6 participants
- Enrollment target
Study Summary
Children with neuromuscular disabilities and limited ambulation are at significant risk for decreased bone mineral density (BMD) and increased incidence of fracture. This is caused, in part, by low levels of load experienced by the skeleton due to a child's functional limitations. Low BMD has been shown to be predictive of fracture, and in fact, fractures usually occur without significant trauma in children with neuromuscular conditions. The discomfort and distress from fractures in this population are considerable, and the associated costs to the family and healthcare system are substantial. Numerous interventions have been devoted to improving BMD in these children. Stationary assisted standing devices are widely used and represent the standard-of-care. However, evidence supporting this approach is limited due to inadequate study designs with insufficient numbers of patients. This study will use load-sensing platforms in patients with neuromuscular conditions. Successful completion of this pilot study will assist in the development of a future multicenter clinical trial to definitively determine relationships, if any, between passive standing and measures of BMD, fracture incidence, pulmonary function, and health-related quality-of-life measures in children with a variety of neuromuscular disabilities (e.g., spinal muscular atrophy, cerebral palsy, muscular dystrophy, spina bifida, Rett syndrome). Hypothesis: Assisted standing treatment program will gradually increase their duration of standing by up to 75% after the baseline phase.
Primary Outcome
Change from baseline in BMD, as , at 10 months.
Interventions
- OTHER Assisted Standing Treatment Program
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2015-12-09 |
| Est. Completion | 2018-03-23 |
| Phase | NA |
What the finished NCT02428673 record still lists
NCT02428673 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Assisted Standing Treatment Program is the first listed.
NCT02428673 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02428673 about?
NCT02428673 is a clinical study titled "Effects of Standing on Non-Ambulatory Children With Neuromuscular Conditions". Children with neuromuscular disabilities and limited ambulation are at significant risk for decreased bone mineral density (BMD) and increased incidence of fracture. This is caused, in part, by low levels of load experienced by the skeleton due to a child's functional limitations. Low BMD has been s...
What is the current status of trial NCT02428673?
This trial is currently completed. It is a NA study. The enrollment target is 6 participants. The study started on 2015-12-09. Estimated completion is 2018-03-23.
What interventions are being tested in trial NCT02428673?
The interventions under investigation include: Assisted Standing Treatment Program (OTHER).
Who is sponsoring clinical trial NCT02428673?
This trial is sponsored by Gillette Children's Specialty Healthcare, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02428673's enrollment target sits among peer trials
6 1983rd of 2000 higher than 13 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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