Vanderbilt University Spasticity Management Program Evaluation Plan
|ClinicalTrials.gov Identifier: NCT00179114|
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : August 20, 2007
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)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Vanderbilt University Spasticity Management Program Evaluation Plan|
|Study Start Date :||August 2002|
|Estimated 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.
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|