<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03250988</url>
  </required_header>
  <id_info>
    <org_study_id>170963</org_study_id>
    <nct_id>NCT03250988</nct_id>
  </id_info>
  <brief_title>Prevalence of Comorbid Spasticity and Urinary Incontinence in Residents of a Long-Term Care Facility</brief_title>
  <official_title>Prevalence of Comorbid Spasticity and Urinary Incontinence in Residents of a Long-Term Care Facility</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Allergan</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Vanderbilt University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to improve spasticity diagnosis through exploration of potential&#xD;
      new diagnostic markers for spasticity that can assist in diagnosis and referral.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to improve spasticity (a form of muscle rigidity) diagnosis through&#xD;
      exploration of potential new diagnostic markers for spasticity that can assist in diagnosis&#xD;
      and referral. This will be done by assessing the relatedness of comorbid conditions in&#xD;
      patients with spasticity. Emphasis will be placed on urinary incontinence, as previous work&#xD;
      has suggested a link between the two conditions. An additional aim of this study is to assess&#xD;
      health-related quality of life measures in this population. A medical record review will be&#xD;
      performed for all consenting participants residing in Tennessee State Veterans' Homes, which&#xD;
      is a long-term care facility in Murfreesboro, TN. Participants will also be asked to complete&#xD;
      a brief questionnaire assessing their perceived health-related quality of life, physical&#xD;
      wellbeing, and mental wellbeing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 30, 2018</start_date>
  <completion_date type="Actual">August 1, 2018</completion_date>
  <primary_completion_date type="Actual">August 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of comorbid spasticity and urinary incontinence in a long-term care facility</measure>
    <time_frame>Up to three months after consent is obtained</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life in residents of a long-term care facility</measure>
    <time_frame>Up to three months after consent is obtained</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical and mental well-being in residents of a long-term care facility</measure>
    <time_frame>Up to three months after consent is obtained</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived disability in residents of a long-term care facility</measure>
    <time_frame>Up to three months after consent is obtained</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <enrollment type="Actual">60</enrollment>
  <condition>Spasticity, Muscle</condition>
  <condition>Muscular Diseases</condition>
  <condition>Musculoskeletal Disease</condition>
  <condition>Muscle Hypertonia</condition>
  <condition>Muscle Spasticity</condition>
  <condition>Neuromuscular Manifestations</condition>
  <condition>Signs and Symptoms</condition>
  <condition>Nervous System Diseases</condition>
  <condition>Neurologic Manifestations</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Neurological Examination</intervention_name>
    <description>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.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Nursing home residents&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female subjects of any race, aged 18 and above&#xD;
&#xD;
          -  Resident of the selected long-term care facility&#xD;
&#xD;
          -  The subject, or if appropriate their medical decision maker, is willing and able to&#xD;
             provide written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects for whom participation in the study may cause medical harm&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Charles, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tennessee State Veterans' Homes</name>
      <address>
        <city>Murfreesboro</city>
        <state>Tennessee</state>
        <zip>37130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Gracies JM. Pathophysiology of spastic paresis. II: Emergence of muscle overactivity. Muscle Nerve. 2005 May;31(5):552-71. doi: 10.1002/mus.20285.</citation>
    <PMID>15714511</PMID>
  </reference>
  <reference>
    <citation>Thompson AJ, Jarrett L, Lockley L, Marsden J, Stevenson VL. Clinical management of spasticity. J Neurol Neurosurg Psychiatry. 2005 Apr;76(4):459-63. doi: 10.1136/jnnp.2004.035972. No abstract available.</citation>
    <PMID>15774425</PMID>
  </reference>
  <reference>
    <citation>Pfister AA, Roberts AG, Taylor HM, Noel-Spaudling S, Damian MM, Charles PD. Spasticity in adults living in a developmental center. Arch Phys Med Rehabil. 2003 Dec;84(12):1808-12. doi: 10.1016/s0003-9993(03)00368-x.</citation>
    <PMID>14669188</PMID>
  </reference>
  <reference>
    <citation>Sommerfeld DK, Eek EU, Svensson AK, Holmqvist LW, von Arbin MH. Spasticity after stroke: its occurrence and association with motor impairments and activity limitations. Stroke. 2004 Jan;35(1):134-9. doi: 10.1161/01.STR.0000105386.05173.5E. Epub 2003 Dec 18.</citation>
    <PMID>14684785</PMID>
  </reference>
  <reference>
    <citation>Welmer AK, von Arbin M, Widen Holmqvist L, Sommerfeld DK. Spasticity and its association with functioning and health-related quality of life 18 months after stroke. Cerebrovasc Dis. 2006;21(4):247-53. doi: 10.1159/000091222. Epub 2006 Jan 27.</citation>
    <PMID>16446538</PMID>
  </reference>
  <reference>
    <citation>Bushman W, Steers WD, Meythaler JM. Voiding dysfunction in patients with spastic paraplegia: urodynamic evaluation and response to continuous intrathecal baclofen. Neurourol Urodyn. 1993;12(2):163-70. doi: 10.1002/nau.1930120210.</citation>
    <PMID>7920673</PMID>
  </reference>
  <reference>
    <citation>Marciniak C, O'Shea SA, Lee J, Jesselson M, Dudas-Sheehan D, Beltran E, Gaebler-Spira D. Urinary incontinence in adults with cerebral palsy: prevalence, type, and effects on participation. PM R. 2014 Feb;6(2):110-20; quiz 120. doi: 10.1016/j.pmrj.2013.07.012. Epub 2013 Aug 23. Erratum In: PM R. 2014 Nov;6(11):1066.</citation>
    <PMID>23978464</PMID>
  </reference>
  <reference>
    <citation>Durrant J, Snape J. Urinary incontinence in nursing homes for older people. Age Ageing. 2003 Jan;32(1):12-8. doi: 10.1093/ageing/32.1.12.</citation>
    <PMID>12540342</PMID>
  </reference>
  <reference>
    <citation>von Gontard A, de Jong TP, Rantell A, Nieuwhof-Leppink A, Badawi JK, Cardozo L. Do we manage incontinence in children and adults with special needs adequately? ICI-RS 2014. Neurourol Urodyn. 2016 Feb;35(2):304-6. doi: 10.1002/nau.22823.</citation>
    <PMID>26872572</PMID>
  </reference>
  <reference>
    <citation>Chua K, Chuo A, Kong KH. Urinary incontinence after traumatic brain injury: incidence, outcomes and correlates. Brain Inj. 2003 Jun;17(6):469-78. doi: 10.1080/02699050210154268.</citation>
    <PMID>12745703</PMID>
  </reference>
  <reference>
    <citation>Offermans MP, Du Moulin MF, Hamers JP, Dassen T, Halfens RJ. Prevalence of urinary incontinence and associated risk factors in nursing home residents: a systematic review. Neurourol Urodyn. 2009;28(4):288-94. doi: 10.1002/nau.20668.</citation>
    <PMID>19191259</PMID>
  </reference>
  <reference>
    <citation>Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.</citation>
    <PMID>21479777</PMID>
  </reference>
  <reference>
    <citation>Janssen MF, Pickard AS, Golicki D, Gudex C, Niewada M, Scalone L, Swinburn P, Busschbach J. Measurement properties of the EQ-5D-5L compared to the EQ-5D-3L across eight patient groups: a multi-country study. Qual Life Res. 2013 Sep;22(7):1717-27. doi: 10.1007/s11136-012-0322-4. Epub 2012 Nov 25.</citation>
    <PMID>23184421</PMID>
  </reference>
  <reference>
    <citation>Johnson TM, Ouslander JG, Uman GC, Schnelle JF. Urinary incontinence treatment preferences in long-term care. J Am Geriatr Soc. 2001 Jun;49(6):710-8. doi: 10.1046/j.1532-5415.2001.49146.x.</citation>
    <PMID>11454108</PMID>
  </reference>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>October 6, 2018</last_update_submitted>
  <last_update_submitted_qc>October 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University Medical Center</investigator_affiliation>
    <investigator_full_name>David Charles</investigator_full_name>
    <investigator_title>Professor and Vice-Chairman of Neurology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Spasticity</mesh_term>
    <mesh_term>Musculoskeletal Diseases</mesh_term>
    <mesh_term>Muscular Diseases</mesh_term>
    <mesh_term>Nervous System Diseases</mesh_term>
    <mesh_term>Neurologic Manifestations</mesh_term>
    <mesh_term>Muscle Hypertonia</mesh_term>
    <mesh_term>Neuromuscular Manifestations</mesh_term>
    <mesh_term>Urinary Incontinence</mesh_term>
    <mesh_term>Enuresis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03250988
org study id: 170963
nct id: NCT03250988
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Cross-Sectional
measure: Prevalence of comorbid spasticity and urinary incontinence in a long-term care facility
time frame: Up to three months after consent is obtained
description: 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.
measure: Quality of life in residents of a long-term care facility
time frame: Up to three months after consent is obtained
description: 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.
measure: Physical and mental well-being in residents of a long-term care facility
time frame: Up to three months after consent is obtained
description: 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.
measure: Perceived disability in residents of a long-term care facility
time frame: Up to three months after consent is obtained
description: 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.
intervention type: Diagnostic Test
intervention name: Neurological Examination
description: 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.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: David Charles, M.D.
role: Principal Investigator
affiliation: Vanderbilt University Medical Center
facility: 
country: United States
citation: Gracies JM. Pathophysiology of spastic paresis. II: Emergence of muscle overactivity. Muscle Nerve. 2005 May;31(5):552-71. doi: 10.1002/mus.20285.
PMID: 15714511
citation: Thompson AJ, Jarrett L, Lockley L, Marsden J, Stevenson VL. Clinical management of spasticity. J Neurol Neurosurg Psychiatry. 2005 Apr;76(4):459-63. doi: 10.1136/jnnp.2004.035972. No abstract available.
PMID: 15774425
citation: Pfister AA, Roberts AG, Taylor HM, Noel-Spaudling S, Damian MM, Charles PD. Spasticity in adults living in a developmental center. Arch Phys Med Rehabil. 2003 Dec;84(12):1808-12. doi: 10.1016/s0003-9993(03)00368-x.
PMID: 14669188
citation: Sommerfeld DK, Eek EU, Svensson AK, Holmqvist LW, von Arbin MH. Spasticity after stroke: its occurrence and association with motor impairments and activity limitations. Stroke. 2004 Jan;35(1):134-9. doi: 10.1161/01.STR.0000105386.05173.5E. Epub 2003 Dec 18.
PMID: 14684785
citation: Welmer AK, von Arbin M, Widen Holmqvist L, Sommerfeld DK. Spasticity and its association with functioning and health-related quality of life 18 months after stroke. Cerebrovasc Dis. 2006;21(4):247-53. doi: 10.1159/000091222. Epub 2006 Jan 27.
PMID: 16446538
citation: Bushman W, Steers WD, Meythaler JM. Voiding dysfunction in patients with spastic paraplegia: urodynamic evaluation and response to continuous intrathecal baclofen. Neurourol Urodyn. 1993;12(2):163-70. doi: 10.1002/nau.1930120210.
PMID: 7920673
citation: Marciniak C, O'Shea SA, Lee J, Jesselson M, Dudas-Sheehan D, Beltran E, Gaebler-Spira D. Urinary incontinence in adults with cerebral palsy: prevalence, type, and effects on participation. PM R. 2014 Feb;6(2):110-20; quiz 120. doi: 10.1016/j.pmrj.2013.07.012. Epub 2013 Aug 23. Erratum In: PM R. 2014 Nov;6(11):1066.
PMID: 23978464
citation: Durrant J, Snape J. Urinary incontinence in nursing homes for older people. Age Ageing. 2003 Jan;32(1):12-8. doi: 10.1093/ageing/32.1.12.
PMID: 12540342
citation: von Gontard A, de Jong TP, Rantell A, Nieuwhof-Leppink A, Badawi JK, Cardozo L. Do we manage incontinence in children and adults with special needs adequately? ICI-RS 2014. Neurourol Urodyn. 2016 Feb;35(2):304-6. doi: 10.1002/nau.22823.
PMID: 26872572
citation: Chua K, Chuo A, Kong KH. Urinary incontinence after traumatic brain injury: incidence, outcomes and correlates. Brain Inj. 2003 Jun;17(6):469-78. doi: 10.1080/02699050210154268.
PMID: 12745703
citation: Offermans MP, Du Moulin MF, Hamers JP, Dassen T, Halfens RJ. Prevalence of urinary incontinence and associated risk factors in nursing home residents: a systematic review. Neurourol Urodyn. 2009;28(4):288-94. doi: 10.1002/nau.20668.
PMID: 19191259
citation: Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
PMID: 21479777
citation: Janssen MF, Pickard AS, Golicki D, Gudex C, Niewada M, Scalone L, Swinburn P, Busschbach J. Measurement properties of the EQ-5D-5L compared to the EQ-5D-3L across eight patient groups: a multi-country study. Qual Life Res. 2013 Sep;22(7):1717-27. doi: 10.1007/s11136-012-0322-4. Epub 2012 Nov 25.
PMID: 23184421
citation: Johnson TM, Ouslander JG, Uman GC, Schnelle JF. Urinary incontinence treatment preferences in long-term care. J Am Geriatr Soc. 2001 Jun;49(6):710-8. doi: 10.1046/j.1532-5415.2001.49146.x.
PMID: 11454108
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University Medical Center
investigator full name: David Charles
investigator title: Professor and Vice-Chairman of Neurology
mesh term: Muscle Spasticity
mesh term: Musculoskeletal Diseases
mesh term: Muscular Diseases
mesh term: Nervous System Diseases
mesh term: Neurologic Manifestations
mesh term: Muscle Hypertonia
mesh term: Neuromuscular Manifestations
mesh term: Urinary Incontinence
mesh term: Enuresis
sharing ipd: No