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Prevalence of Spasticity in Veterans Living in a Long-term Care Facility

This study has been completed.
Merz Pharmaceuticals, LLC
Information provided by (Responsible Party):
David Charles, Vanderbilt University Identifier:
First received: June 12, 2013
Last updated: January 25, 2016
Last verified: January 2016
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.


Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Prevalence of Spasticity in Veterans Living in a Long-term Care Facility

Resource links provided by NLM:

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Spasticity diagnosis [ Time Frame: Up to three months after consent is obtained ]
    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.

Secondary Outcome Measures:
  • Spasticity treatment awareness and preferences survey [ Time Frame: Up to three months after consent is obtained ]

    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".

Enrollment: 54
Study Start Date: February 2013
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Detailed Description:
The goal of this feasibility survey is to determine the prevalence of spasticity that interferes with care or function at the Tennessee State Veterans Home (TSVH), which is a long-term care facility for veterans and their spouses in Murfreesboro, Tennessee. In order to accomplish this goal, each of the 140 residents will be examined by the principal investigator and a medical record review will be performed; also, each patient and their medical decision-maker (if applicable), direct caregiver, and treating physician will be surveyed in order to further elucidate the barriers to treatment in this population. All consenting residents of the TSVH will be examined, but the data will be separated prior to analysis based on whether the resident is a veteran or a veteran's relative.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Nursing home residents

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01879449

United States, Tennessee
Tennessee State Veterans Home
Murfreesboro, Tennessee, United States, 37130
Sponsors and Collaborators
Vanderbilt University
Merz Pharmaceuticals, LLC
Principal Investigator: David Charles, M.D. Vanderbilt University
  More Information

Responsible Party: David Charles, Professor and Vice-Chair, Department of Neurology, Vanderbilt University Identifier: NCT01879449     History of Changes
Other Study ID Numbers: 110470VU
VUMC38674-R ( Other Grant/Funding Number: Merz Pharma )
VUMC35131-R ( Other Grant/Funding Number: Allergan, Inc. )
Study First Received: June 12, 2013
Last Updated: January 25, 2016

Keywords provided by Vanderbilt University:

Additional relevant MeSH terms:
Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms processed this record on May 24, 2017