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NCT00179114 · ClinicalTrials.gov registry record · Phase 4
Vanderbilt University Spasticity Management Program Evaluation Plan
A Phase 4 study, sponsored by Vanderbilt University.
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
NCT00179114 is a Phase 4 study that has completed, run by Vanderbilt University. The registered enrollment target is 20 participants.
The verdict
NCT00179114, a Phase 4 study, has completed, sponsored by Vanderbilt University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
Study Summary
People with severe developmental disabilities frequently have comorbidities that make providing care to them more difficult. Spasticity is one such comorbidity. It produces increased muscle tone that can cause stiffness in joints and bodily contortions that can interfere with all of the major types of care provided to participants. Typically, care areas include splinting, hygiene, dressing, transfers, positioning, ambulation, and engaging in other functional activities. Moreover, persons with spasticity often experience pain. Typically, spasticity is managed by health care providers using a combination of the following therapies: * Physical / occupational therapy (PT / OT) * Oral medication * Botox injections * Intrathecal baclofen administered by the Medtronic SyncroMed pump (ITB) * Orthopedic / neurological surgery
Interventions
- DRUG Botulinum Toxin Type A
- DRUG Intrathecal baclofen administered by the Medtronic SyncroMed(TM) pump (ITB)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2002-08 |
| Est. Completion | 2006-02 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00179114
The ClinicalTrials.gov registry entry for NCT00179114 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University, which has 430 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Botulinum Toxin Type A is the first listed.
NCT00179114 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00179114 about?
NCT00179114 is a clinical study titled "Vanderbilt University Spasticity Management Program Evaluation Plan". People with severe developmental disabilities frequently have comorbidities that make providing care to them more difficult. Spasticity is one such comorbidity. It produces increased muscle tone that can cause stiffness in joints and bodily contortions that can interfere with all of the major types ...
What is the current status of trial NCT00179114?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2002-08. Estimated completion is 2006-02.
What interventions are being tested in trial NCT00179114?
The interventions under investigation include: Botulinum Toxin Type A (DRUG), Intrathecal baclofen administered by the Medtronic SyncroMed(TM) pump (ITB) (DRUG).
Who is sponsoring clinical trial NCT00179114?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
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