drugset / Trial / NCT00179114

Vanderbilt University Spasticity Management Program Evaluation Plan

NCT00179114

Non-randomizedSingle-groupOpen-labelTreatment

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

Timeline

Start
2002-08
Primary completion
Completion
2006-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Baclofen Small molecule Intrathecal
Subject Botulinum toxin type A Protein / enzyme biologic

Indications

No indication recorded.