Vanderbilt University Spasticity Management Program Evaluation Plan

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University; Vanderbilt University Medical Center
• Collaborators: Allergan; Medtronic
• Treatments: abobotulinumtoxinA; Baclofen; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.