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

Not Applicable

Completed

• Conditions: Muscle Spasticity; Cerebral Palsy
• Interventions: Device: Low-magnitude vibration; Drug: Botox

• Registration Number: NCT01803464
• Lead Sponsor: University of Delaware

Brief 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.

Detailed 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).

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2013-02-27
• Study First Submitted QC: 2013-02-28
• Study First Posted: 2013-03-04
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Results First Submitted: 2017-01-30
• Status Verified: 2018-02
• Results First Submitted QC: 2018-02-20
• Last Update Submitted: 2018-02-20
• Results First Posted: 2018-03-20
• Last Update Posted: 2018-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Botox plus low-magnitude vibration	Low-magnitude vibration	Cerebral palsy and Botox + vibration
Botox	Botox	Cerebral palsy and Botox
Botox plus low-magnitude vibration	Botox	Cerebral palsy and Botox + vibration

Primary Outcome Measures

Name	Time	Method
Bone Structure	baseline to 6 months	Change in cortical bone volume of the middle third of the tibia from baseline to 6 months, as measured by MRI.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

University of Delaware; 🇺🇸 Newark, Delaware, United States

Alfred I. duPont Hospital for Children, Nemours; 🇺🇸 Wilmington, Delaware, United States