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

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Delaware
• Collaborators: Alfred I. duPont Hospital for Children; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion (Children with CP):

1. Have spastic CP

2. Between 2-12 years of age

3. 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.

4. A score of 1-4 on the gross motor function classification scale (GMFCS)

Exclusion (Children with CP):

1. Botox treatment in the lower extremities within the last year

2. Metal rods in both legs

Inclusion (Typically developing children):

1. Between 2 and 12 years of age.

2. Match a child with CP for sex, age and race.

Exclusion(Typically developing children):

1. Neurological disorder

2. Surgery in the lower extremities within the last year.

3. Chronic medication use