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Completed

NCT Number: NCT03250988

Prevalence of Comorbid Spasticity and Urinary Incontinence in Residents of a Long-Term Care Facility

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.

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Key information

Conditions

Spasticity, Muscle Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Disease Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tennessee State Veterans' Homes

Murfreesboro, Tennessee, 37130, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neurological Examination

Diagnostic Test

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.

Primary outcomes

  1. Prevalence of comorbid spasticity and urinary incontinence in a long-term care facility

    Time frame: 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 outcomes

  1. Quality of life in residents of a long-term care facility

    Time frame: 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.

  2. Physical and mental well-being in residents of a long-term care facility

    Time frame: 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.

  3. Perceived disability in residents of a long-term care facility

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • Allergan

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 16, 2017
Registry last updated
Oct 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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