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

University of Delaware

Status: Completed

Conditions: Cerebral Palsy; Muscle Spasticity

Treatments: Drug: Botox; Device: Low-magnitude vibration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01803464

IRB # 115648-11 (Other Identifier)

1R15HD071397-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 29 patients

Sex: All

Ages: 2 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 4 patient groups

Botox plus low-magnitude vibration

Experimental group

Description:

Cerebral palsy and Botox + vibration

Treatment:

Drug: Botox

Device: Low-magnitude vibration

Botox

Experimental group

Description:

Cerebral palsy and Botox

Treatment:

Drug: Botox

Cerebral palsy control

No Intervention group

Description:

Cerebral palsy without treatment

Typically developing control

No Intervention group

Description:

Typically developing