Clinical trial NCT03250988: Prevalence of Comorbid Spasticity and Urinary Incontinence in Residents of a Long-Term Care Facility
Official title: Prevalence of Comorbid Spasticity and Urinary Incontinence in Residents of a Long-Term Care Facility
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spasticity, Muscle
Muscular Diseases
Musculoskeletal Disease
Muscle Hypertonia
Muscle Spasticity
Neuromuscular Manifestations
Signs and Symptoms
Nervous System Diseases
Neurologic Manifestations
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2017-08-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nursing home residents

Brief summary: The purpose of this study is to improve spasticity diagnosis through exploration of potential new diagnostic markers for spasticity that can assist in diagnosis and referral.

Detailed description: The aim of this study is to improve spasticity (a form of muscle rigidity) diagnosis through exploration of potential new diagnostic markers for spasticity that can assist in diagnosis and referral. This will be done by assessing the relatedness of comorbid conditions in patients with spasticity. Emphasis will be placed on urinary incontinence, as previous work has suggested a link between the two conditions. An additional aim of this study is to assess health-related quality of life measures in this population. A medical record review will be performed for all consenting participants residing in Tennessee State Veterans' Homes, which is a long-term care facility in Murfreesboro, TN. Participants will also be asked to complete a brief questionnaire assessing their perceived health-related quality of life, physical wellbeing, and mental wellbeing.

Eligibility criteria: Inclusion Criteria:

* Male or female subjects of any race, aged 18 and above
* Resident of the selected long-term care facility
* The subject, or if appropriate their medical decision maker, is willing and able to provide written informed consent.

Exclusion Criteria:

* Subjects for whom participation in the study may cause medical harm

Primary outcomes:
measure: Prevalence of comorbid spasticity and urinary incontinence in a long-term care facility
timeFrame: Up to three months after consent is obtained
Secondary outcomes:
measure: Quality of life in residents of a long-term care facility
timeFrame: Up to three months after consent is obtained
measure: Physical and mental well-being in residents of a long-term care facility
timeFrame: Up to three months after consent is obtained
measure: Perceived disability in residents of a long-term care facility
timeFrame: Up to three months after consent is obtained
Other outcomes:
Locations:
city: Murfreesboro
country: United States
facility: Tennessee State Veterans' Homes
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: David Charles, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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