Effect of Botox and Vibration on Bone in Children With Cerebral Palsy

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byFreeman Miller, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Delaware

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Christopher Modlesky, PhD

Principal Investigator

University of Delaware

Freeman Miller, MD

Principal Investigator

Nemours/Alfred I duPont Hospital for Children

Eligibility Criteria

Inclusion Criteria

Have spastic CP

Between 2-12 years of age

Recommended for Botox treatment by their physician as part of their clinical care. Those who accept Botox treatment and those who do not accept Botox treatment are both eligible for the study.

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