Effect of Botox and Vibration on Bone in Children With Cerebral Palsy
| Status: | Completed |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 2 - 12 |
| Updated: | 4/17/2018 |
| Start Date: | March 2012 |
| End Date: | February 2015 |
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.
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.
The investigators have been working with children diagnosed with cerebral palsy (CP) for the
past 10 years. The investigators have found that bone structure is markedly underdeveloped
and bone strength is severely compromised in children with CP. Also, an increased fracture
rate has been observed in the lower extremity bones of children with CP. There is evidence
that Botox, which is used to treat spasticity in CP, can improve motor function; however the
effect of Botox on human bone is unknown. There is also evidence that low magnitude vibration
treatment can improve bone mass and bone structure. The overall goal of this current research
study is to investigate the effect and mechanism of action of Botox and vibration on bone in
children with CP. The investigators will also examine the effect of Botox on muscle volume.
A total of 36 participants will participate in this study. The investigators will assess bone
structure and muscle volume using MRI. The investigators will assess bone mass using
dual-energy X-ray absorptiometry (DXA).
past 10 years. The investigators have found that bone structure is markedly underdeveloped
and bone strength is severely compromised in children with CP. Also, an increased fracture
rate has been observed in the lower extremity bones of children with CP. There is evidence
that Botox, which is used to treat spasticity in CP, can improve motor function; however the
effect of Botox on human bone is unknown. There is also evidence that low magnitude vibration
treatment can improve bone mass and bone structure. The overall goal of this current research
study is to investigate the effect and mechanism of action of Botox and vibration on bone in
children with CP. The investigators will also examine the effect of Botox on muscle volume.
A total of 36 participants will participate in this study. The investigators will assess bone
structure and muscle volume using MRI. The investigators will assess bone mass using
dual-energy X-ray absorptiometry (DXA).
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
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