Vanderbilt University Spasticity Management Program Evaluation Plan

Primary Outcome Measures:

• 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.
  

Secondary Outcome Measures:

• 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.
  

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.