ClinicalTrials.gov record

Completed Not applicable Interventional Accepts healthy volunteers Results available

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

ClinicalTrials.gov ID: NCT01803464

Public ClinicalTrials.gov record NCT01803464. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT01803464
Recruitment status: Completed
Study type: Interventional
Phase: Not applicable
Lead sponsor: University of Delaware; Other
Enrollment: 29 participants

Conditions and interventions

Conditions

Interventions

Low-magnitude vibration Device
Botox Drug

Device · Drug

Eligibility (public fields only)

Age range: 2 Years to 12 Years
Sex: All
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Feb 29, 2012
Primary completion: Jan 31, 2015
Completion: Jan 31, 2015
Last update posted: Mar 19, 2018

2012 – 2015

United States locations

U.S. sites: 2
U.S. states: 1
U.S. cities: 2

Facility	City	State	ZIP	Site status
University of Delaware	Newark	Delaware	19716	—
Alfred I. duPont Hospital for Children, Nemours	Wilmington	Delaware	19899	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01803464, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Mar 19, 2018 · Synced Sep 10, 2026

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The complete protocol, eligibility criteria, and contact information for NCT01803464 live on ClinicalTrials.gov.

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