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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 is a NA study that has completed, run by University of Delaware. The registered enrollment target is 29 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01803464
The ClinicalTrials.gov registry entry for NCT01803464 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Delaware, which has 106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Botox is the first listed.
NCT01803464 reports 0 study locations.
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.
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