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NCT01803464 · ClinicalTrials.gov registry record · NA
Effect of Botox and Vibration on Bone in Children With Cerebral Palsy
A NA study, sponsored by University of Delaware.
- Completed
- Registry status
- NA
- Development phase
- 29
- Enrollment target
NCT01803464: Completed NA study, sponsored by University of Delaware.
NCT01803464 is a NA study that has completed, run by University of Delaware. The registered enrollment target is 29 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01803464, a NA study, has completed, sponsored by University of Delaware.
- COMPLETED
- Registry status
- NA
- Development phase
- 29 participants
- Enrollment target
Study 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.
Primary Outcome
Change in cortical bone volume of the middle third of the tibia from baseline to 6 months, as measured by MRI.
Interventions
- DRUG Botox
- DEVICE Low-magnitude vibration
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2012-03 |
| Est. Completion | 2015-02 |
| Phase | NA |
What the finished NCT01803464 record still lists
NCT01803464 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Botox is the first listed.
NCT01803464 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01803464 about?
NCT01803464 is a clinical study titled "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...
What is the current status of trial NCT01803464?
This trial is currently completed. It is a NA study. The enrollment target is 29 participants. The study started on 2012-03. Estimated completion is 2015-02.
What interventions are being tested in trial NCT01803464?
The interventions under investigation include: Botox (DRUG), Low-magnitude vibration (DEVICE).
Who is sponsoring clinical trial NCT01803464?
This trial is sponsored by University of Delaware, which has 106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01803464's enrollment target sits among peer trials
29 1702nd of 2000 higher than 297 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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