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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Cerebral Palsy, Muscle Spasticity

Intervention / Treatment
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* Device: Low-magnitude vibration
* Drug: Botox


Participation Criteria
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Eligibility Criteria
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Inclusion (Children with CP): 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. A score of 1-4 on the gross motor function classification scale (GMFCS) Exclusion (Children with CP): Botox treatment in the lower extremities within the last year Metal rods in both legs Inclusion (Typically developing children): Between 2 and 12 years of age. Match a child with CP for sex, age and race. Exclusion(Typically developing children): Neurological disorder Surgery in the lower extremities within the last year. Chronic medication use

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botox plus low-magnitude vibration<br>Cerebral palsy and Botox + vibration | Device: Low-magnitude vibration<br>* Children will receive a daily low-magnitude vibration treatment.<br>Drug: Botox<br>* Children who are candidates to receive Botox as part of their standard of care.<br>|
| Experimental: Botox<br>Cerebral palsy and Botox | Drug: Botox<br>* Children who are candidates to receive Botox as part of their standard of care.<br>|
| No Intervention: Cerebral palsy control<br>Cerebral palsy without treatment | |
| No Intervention: Typically developing control<br>Typically developing | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Structure | Change in cortical bone volume of the middle third of the tibia from baseline to 6 months, as measured by MRI. | baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle Volume | Change in muscle volume of the midleg from baseline to 6 months, as measured by MRI | baseline to 6 months | 
| Bone Mass | Change in bone mineral content in the distal femur from baseline to 6 months, as measured by dual-energy X-ray absorptiometry (DXA) | baseline to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Botox, Muscle strength