Spasticity Clinical Trial
Official title:
Prevalence of Spasticity in Veterans Living in a Long-term Care Facility
Verified date | January 2016 |
Source | Vanderbilt University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
The purpose of the study is to conduct a feasibility survey of the prevalence of spasticity at a single long-term care facility for veterans and their spouses in Murfreesboro, Tennessee. These data will be used to strengthen a future grant application to the Department of Defense in response to their ongoing Traumatic Brain Injury initiative.
Status | Completed |
Enrollment | 54 |
Est. completion date | May 2014 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Male and female subjects of any race, aged 18 and above. - Reside at the Tennessee State Veterans Home Exclusion Criteria: - Subjects for whom it is felt that participation in the study would cause medical harm |
Observational Model: Cohort, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
United States | Tennessee State Veterans Home | Murfreesboro | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University | Allergan, Merz Pharmaceuticals, LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Spasticity diagnosis | There is no biomarker for spasticity. Therefore, the diagnosis will be made on physician impression. A neurologist trained in movement disorders will examine each consented patient to determine if they have spasticity. The severity of the veteran's spasticity will be documented, including the following measures: presence of fixed contractures and presence of pain on movement. | Up to three months after consent is obtained | No |
Secondary | Spasticity treatment awareness and preferences survey | The investigators will use a structured interview to assess each subject's level of awareness of available treatments for spasticity. Subjects will be asked if they are aware of specific treatments for spasticity and asked to answer "yes" or "no". This interview is also designed to capture subjects' spasticity treatment preferences. Subjects will be asked if they are interested in receiving a variety of available spasticity treatments and asked to answer "yes," "no," or "maybe". |
Up to three months after consent is obtained | No |
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