Vanderbilt University Spasticity Management Program Evaluation Plan
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
Drug: Botulinum Toxin Type A
Drug: Intrathecal baclofen administered by the Medtronic SyncroMed(TM) pump (ITB)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Vanderbilt University Spasticity Management Program Evaluation Plan|
- 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.
|Study Start Date:||August 2002|
|Estimated Study Completion Date:||February 2006|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00179114
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37212|
|Principal Investigator:||David Charles, MD||Vanderbilt University Department of Neurology|