Effects of Standing on Non-Ambulatory Children With Neuromuscular Conditions

Completed · Not applicable

Conditions studied: Osteopenia, Spinal Muscular Atrophy, Cerebral Palsy, Muscular Dystrophy, Spina Bifida, Rett Syndrome

In brief

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.

Key facts

Study ID

NCT02428673

Run by

Gillette Children's Specialty Healthcare

People needed

6

Starts

2015-12-09

Expected to finish

2018-03-23

Last updated by the study team

2021-02-21

Who can join

Age: 3 and older, up to 14. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must have a neuromuscular condition
• Must be between 3-14 years old
• Gross Motor Function Classification System (GMFCS) Level IV or V
• Must be on a standing treatment program
• Parent must be able to provide consent

You may not qualify if…

• Currently taking bisphosphonates

Where it is running

• Gillette Children's Specialty Healthcare — Saint Paul, Minnesota, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.