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More info
You can access this
clinical trial
if you have
Osteogenesis Imperfecta
and you are
between 5 and 16
years old
-
The phase for this study is not defined.
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The purpose

Children with osteogenesis imperfecta (OI) have impaired bone strength, fractures, weak muscles and limited mobility. Mild to moderate forms of OI (type 1 and 4) may benefit from muscle training that leads to secondary improvement in bone strength (osteogenic treatment). Recent studies in children with cerebral palsy but also OI suggest that Whole Body Vibration Training (WBVT) improves mobility and also bone strength. No randomized controlled trials exist in OI children. This randomized controlled pilot study assesses the effect of 5 months WBVT (2 x 9min/day) on muscle function, mobility, bone structure and density. 24 children >5 years with OI type 1 and 4 with limited mobility (CHAQ Score ≥0.13) will be randomized into a WBVT group and a control group matched by gender and pubertal stage. Main outcome measure is the change in tibial volumetric BMD, secondary outcomes include a variety of bone, mobility and dynamic muscle function variables.

Provided treatments

  • Device: Galileo M
Tris trial is registered with FDA with number: NCT03029312. The sponsor of the trial is Birmingham Women's and Children's NHS Foundation Trust and it is looking for 24 volunteers for the current phase.
Official trial title:
Whole Body Vibration as an Osteogenic Treatment for Children With Osteogenesis Imperfecta With Limited Mobility: A Randomised Controlled Pilot Trial