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

NCT03250988 | Completed

• 1 other identifier: 170963
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  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.

  Up to three months after consent is obtained

Secondary Outcomes (3)

• Quality of life in residents of a long-term care facility

  Up to three months after consent is obtained

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

  Up to three months after consent is obtained

• Perceived disability in residents of a long-term care facility

  Up to three months after consent is obtained

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Nursing home residents

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Allergan: collaborator

Study Sites (1)

Tennessee State Veterans' Homes

Murfreesboro, Tennessee, 37130, United States

Location

Related Publications (14)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 23978464 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Muscle Spasticity; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Signs and Symptoms; Nervous System Diseases; Neurologic Manifestations

Interventions

Neurologic Examination

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Physical Examination

Study Officials

• David Charles, M.D.

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Vice-Chairman of Neurology

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: August 16, 2017
• Study Start: January 30, 2018
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: October 9, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)