Vanderbilt University Spasticity Management Program Evaluation Plan

Study Description

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Brief 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

Condition or disease	Intervention/treatment	Phase
Spasticity	Drug: Botulinum Toxin Type A; Drug: Intrathecal baclofen administered by the Medtronic SyncroMed(TM) pump (ITB)	Phase 4

Detailed Description:

As individuals are identified as appropriate participants for the Program and consent is obtained, the care team for each person, consisting of both medical and caregiver staff, will define up to three specific care area goals and related tasks for treatment. A comprehensive spasticity management program will then be developed for the individual. Clinical and outcome assessments at baseline and at follow-up will include measures of range of motion, global spasticity according to a modified Ashworth scale, and the time and number of staff required for the task. In addition, video will be obtained of caregivers performing each participant's care area tasks at baseline and follow-up to allow an independent external reviewer to judge task difficulty. Treatment will be provided as outlined by the spasticity management plan. Follow-up evaluations will be conducted when the participant is at least one year from their initial Botulinum injection, or are one year post-implant for ITB participants. When the participant is exited from the study, Survey Physician will be asked to rate the overall impact of the Program on each of the individual's care area tasks.

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	20 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Vanderbilt University Spasticity Management Program Evaluation Plan
Study Start Date :	August 2002
Study Completion Date :	February 2006

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Total time (in seconds) spent by caregivers to complete a defined care area task at one year followup.
2. Categorical rating by blinded, independent reviewer of baseline and one-year care area task videos.

Secondary Outcome Measures :

1. Range of motion score for each care area goal, assigned by physical therapist and compared at baseline vs. one-year followup.
2. Differences in the number of hospital admissions 12 months pre- and 12 months post-program.
3. Differences in costs associated with caregiving 12 months pre- and 12 months post-treatment.
4. Difference in Physician's global assessment of spasticity at baseline and one-year followup.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212

Sponsors and Collaborators

Vanderbilt University

Allergan

Medtronic

Investigators

Principal Investigator:	David Charles, MD	Vanderbilt University Department of Neurology

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00179114 History of Changes
Other Study ID Numbers:	SMPEP-9.1
First Posted:	September 15, 2005
Last Update Posted:	August 20, 2007
Last Verified:	August 2007

Keywords provided by Vanderbilt University:

Spasticity; Developmental Disabilities; Intrathecal baclofen (ITB); Botulinum Toxin Type A (Botox)

Additional relevant MeSH terms:

Muscle Hypertonia; Muscle Spasticity; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Botulinum Toxins; Botulinum Toxins, Type A	onabotulinumtoxinA; abobotulinumtoxinA; Acetylcholine Release Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Neurotransmitter Agents; Physiological Effects of Drugs; Neuromuscular Agents; Peripheral Nervous System Agents