Vanderbilt University Spasticity Management Program Evaluation Plan

Completed · Phase 4

Conditions studied: Spasticity

In brief

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

Key facts

Study ID

NCT00179114

Run by

Vanderbilt University

People needed

20

Starts

2002-08-01

Expected to finish

2006-02-01

Last updated by the study team

2007-08-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult with spasticity residing at Clover Bottom Developmental Center in Nashville, Tennessee.
• Spasticity must interfere with daily functioning.
• Care team must be able to identify at least one treatment goal for the potential participant.

You may not qualify if…

• Family or guardian is unwilling to provide written informed consent.
• Spasticity does not interfere with patient's day-to-day care.
• Staff who provide daily care are unable to identify a clear treatment goal.

Where it is running

• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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