CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 29 enrolled
Drug / intervention
Botox +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01803464
NCT01803464N/ACompleted

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

University of Delaware·interventional·Posted Mar 4, 2013·Updated Mar 20, 2018

In Brief

A clinical study evaluating Low-magnitude vibration and Botox for Cerebral Palsy and Muscle Spasticity. Completed, enrolled 29 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 4, 2013
Enrollment StartMar 1, 2012
Primary CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 13.3 years ago

Interventions

Low-magnitude vibrationdevice

Children will receive a daily low-magnitude vibration treatment.

Botoxdrug

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