Effect of Botox and Vibration on Bone in Children With Cerebral Palsy
Low-magnitude vibration
+ Botox
+ Botox
Brain Damage, Chronic+10
+ Brain Diseases
+ Central Nervous System Diseases
Treatment Study
Summary
Study start date: March 1, 2012
Actual date on which the first participant was enrolled.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).
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.29 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 2 to 12 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.4 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
No InterventionGroup IV
No InterventionStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Alfred I. duPont Hospital for Children, Nemours
Wilmington, United States