Vanderbilt University Spasticity Management Program Evaluation Plan
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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
Full description
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.
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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