Spasticity, Muscle, Muscular Diseases, Musculoskeletal Disease, Muscle Hypertonia, Muscle Spasticity, Neuromuscular Manifestations, Signs and Symptoms, Nervous System Diseases, Neurologic Manifestations
Conditions
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.
Interventions
DIAGNOSTIC_TESTNeurological Examination
The subject will undergo elements of the neurological examination during which the movement disorders neurologist will look specifically for the presence of spasticity. If spasticity is found to be present during the examination, the neurologist will rate the severity of the spasticity in all affected limbs and record whether they would recommend treatment for spasticity, and if so, which treatment(s) they believe would be beneficial for the subject.
Sponsors
Allergan
Vanderbilt University Medical Center
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of comorbid spasticity and urinary incontinence in a long-term care facility | Up to three months after consent is obtained | Prevalence of spasticity will be determined by recording the presence/absence of spasticity based on the neurological examination performed on all consenting residents of the long-term care facility. Prevalence of urinary incontinence will be determined by medical record review of all consenting residents of the long-term care facility. The research coordinator will report prevalence of comorbid spasticity and incontinence as a descriptive statistic. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life in residents of a long-term care facility | Up to three months after consent is obtained | Subjects (if able) will be asked to complete the EQ-5D-5L questionnaire assessing their perceived health-related quality of life. If the subject is unable to complete the EQ-5D-5L questionnaire, the legal medical decision maker or a relative or friend will be asked to complete the EQ-5D-5L proxy to patient questionnaire, assessing the proxy's view of how the subject perceives their health-related quality of life. |
| Physical and mental well-being in residents of a long-term care facility | Up to three months after consent is obtained | Subjects (if able) will be asked to complete the EQ-5D-5L questionnaire assessing their physical and mental well-being. If the subject is unable to complete the EQ-5D-5L questionnaire, the legal medical decision maker or a relative or friend will be asked to complete the EQ-5D-5L proxy to patient questionnaire, assessing the proxy's view of how the subject perceives their physical and mental well-being. |
| Perceived disability in residents of a long-term care facility | Up to three months after consent is obtained | Subjects (if able) will be asked to complete the EQ-5D-5L questionnaire assessing their perceived disability. If the subject is unable to complete the EQ-5D-5L questionnaire, the legal medical decision maker or a relative or friend will be asked to complete the EQ-5D-5L proxy to patient questionnaire, assessing the proxy's view of how the subject perceives their disability. |
Countries
United States
Outcome results
None listed