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Neurotoxin

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

N/A
Waitlist Available
Led By Christopher Modlesky, PhD
Research Sponsored by University of Delaware
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 6 months
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

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.

Eligible Conditions
  • Cerebral Palsy
  • Spasticity
  • Muscle Spasms

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Bone Structure
Secondary study objectives
Bone Mass
Muscle Volume

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Botox plus low-magnitude vibrationExperimental Treatment2 Interventions
Cerebral palsy and Botox + vibration
Group II: BotoxExperimental Treatment1 Intervention
Cerebral palsy and Botox
Group III: Cerebral palsy controlActive Control1 Intervention
Cerebral palsy without treatment
Group IV: Typically developing controlActive Control1 Intervention
Typically developing
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Low-magnitude vibration
2012
N/A
~30
Botulinum toxin type A
FDA approved

Find a Location

Who is running the clinical trial?

University of DelawareLead Sponsor
161 Previous Clinical Trials
25,563 Total Patients Enrolled
5 Trials studying Cerebral Palsy
269 Patients Enrolled for Cerebral Palsy
Alfred I. duPont Hospital for ChildrenOTHER
23 Previous Clinical Trials
5,030,026 Total Patients Enrolled
2 Trials studying Cerebral Palsy
1,056 Patients Enrolled for Cerebral Palsy
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,063 Previous Clinical Trials
2,746,310 Total Patients Enrolled
33 Trials studying Cerebral Palsy
8,883 Patients Enrolled for Cerebral Palsy
~2 spots leftby Dec 2025
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