Vanderbilt University Spasticity Management Program Evaluation Plan
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ClinicalTrials.gov Identifier: NCT00179114 |
Recruitment Status
:
Completed
First Posted
: September 15, 2005
Last Update Posted
: August 20, 2007
|
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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 |
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 |
- Total time (in seconds) spent by caregivers to complete a defined care area task at one year followup.
- Categorical rating by blinded, independent reviewer of baseline and one-year care area task videos.
- Range of motion score for each care area goal, assigned by physical therapist and compared at baseline vs. one-year followup.
- Differences in the number of hospital admissions 12 months pre- and 12 months post-program.
- Differences in costs associated with caregiving 12 months pre- and 12 months post-treatment.
- Difference in Physician's global assessment of spasticity at baseline and one-year followup.

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00179114
United States, Tennessee | |
Vanderbilt University Medical Center | |
Nashville, Tennessee, United States, 37212 |
Principal Investigator: | David Charles, MD | Vanderbilt University Department of Neurology |
ClinicalTrials.gov Identifier: | NCT00179114 History of Changes |
Other Study ID Numbers: |
SMPEP-9.1 |
First Posted: | September 15, 2005 Key Record Dates |
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 |