Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a NA study that has completed, run by Gillette Children's Specialty Healthcare. The registered enrollment target is 6 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02428673
The ClinicalTrials.gov registry entry for NCT02428673 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 6 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 0 conditions, and to 1 intervention - of which Assisted Standing Treatment Program is the first listed.
NCT02428673 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.