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Vanderbilt University Spasticity Management Program Evaluation Plan

NCT00179114 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2007-08-20

No results posted yet for this 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

Conditions

  • Spasticity

Interventions

DRUG

Botulinum Toxin Type A

DRUG

Intrathecal baclofen administered by the Medtronic SyncroMed(TM) pump (ITB)

Sponsors & Collaborators

  • Allergan

    collaborator INDUSTRY

  • Medtronic

    collaborator INDUSTRY

  • Vanderbilt University

    lead OTHER

Principal Investigators

  • David Charles, MD · Vanderbilt University Department of Neurology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-08-31
Completion
2006-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00179114 on ClinicalTrials.gov