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NCT Number: NCT01803464

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

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Delaware, Newark, Delaware, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low-magnitude vibration

Device

Children will receive a daily low-magnitude vibration treatment.

Botox

Drug

Children who are candidates to receive Botox as part of their standard of care.

Primary outcomes

  1. Bone Structure

    Time frame: 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 outcomes

  1. Muscle Volume

    Time frame: baseline to 6 months

    Change in muscle volume of the midleg from baseline to 6 months, as measured by MRI

  2. Bone Mass

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of Delaware

Other

Collaborators

  • Alfred I. duPont Hospital for Children
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Mar 4, 2013
Registry last updated
Mar 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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