A Phase 4 interventional study of Botulinum Toxin Type A and Intrathecal baclofen administered by the Medtronic SyncroMed(TM) pump (ITB) in Spasticity, sponsored by Vanderbilt University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-08-20.
Sponsored by Vanderbilt University · Phase 4, Interventional, and Treatment
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:
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.
704 studies on the registry are indexed under Muscle Spasticity; 149 are open to participants now.
This study's enrollment of 20 is below the median of 36 across 525 interventional studies indexed under Muscle Spasticity.
Browse Muscle Spasticity studies →Vanderbilt University is the lead sponsor of 508 studies on the registry; 19 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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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