Effect of Botox and Vibration on Bone in Children With Cerebral Palsy
Completed · Not applicable
Conditions studied: Cerebral Palsy, Muscle Spasticity
In brief
Cerebral palsy (CP) is a neuromuscular disorder that affects approximately 800,000 individuals in the U.S. An estimated 70-80% of these individuals have spasticity which affects ambulation and requires management. Therefore, the treatment of spasticity is a primary goal of interventions for children with CP. One treatment widely used to reduce spasticity is Botox because of its ability to temporarily paralyze a muscle. However, no studies have determined the effect of Botox treatment on bone in humans. Also, a low magnitude vibration treatment has been shown to improve bone structure in the lower extremity bones of children with CP. The aims of this study are: 1) to determine the effect of Botox treatment in conjunction with a daily vibration treatment on bone mass and bone structure in children with spastic CP, and 2) to identify the mechanism that underlies the effect of Botox and vibration on bone.
Key facts
- Study ID
- NCT01803464
- Run by
- University of Delaware
- People needed
- 29
- Starts
- 2012-03-01
- Expected to finish
- 2015-02-01
- Last updated by the study team
- 2018-03-20
Who can join
Age: 2 and older, up to 12. Sex: any. Healthy volunteers: accepted.
Where it is running
- University of Delaware — Newark, Delaware, United States
- Alfred I. duPont Hospital for Children, Nemours — Wilmington, Delaware, United States
Full record on ClinicalTrials.gov
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