Status:
COMPLETED
Vanderbilt University Spasticity Management Program Evaluation Plan
Lead Sponsor:
Vanderbilt University
Collaborating Sponsors:
Allergan
Medtronic
Conditions:
Spasticity
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 ...
Detailed 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 thre...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
End Date :
February 1 2006
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00179114
Start Date
August 1 2002
End Date
February 1 2006
Last Update
August 20 2007
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212