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Spasticity, MuscleNCT03250988

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

An observational study of Spasticity, Muscle and Muscular Diseases, run by Vanderbilt University Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Neurological Examination
How many people
60 participants
Where
1 siteUnited States
Study dates
30 Jan 2018to 1 Aug 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Nursing home residents

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Tennessee State Veterans' Homes

    Murfreesboro, Tennessee, 37130

Other trials in United States

About this study

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.

Read the 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.

Being tested
Neurological Examination
Medical subject headings
Muscle Spasticity, Muscular Diseases, Musculoskeletal Diseases, Muscle Hypertonia, Neuromuscular Manifestations, Signs and Symptoms, Nervous System Diseases, Neurologic Manifestations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neurological ExaminationDiagnostic 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to three months after consent is obtained

Secondary outcomes (3)

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

    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.

    Measured: Up to three months after consent is obtained

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

    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.

    Measured: Up to three months after consent is obtained

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

    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.

    Measured: Up to three months after consent is obtained

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2017
  2. Study start30 Jan 2018
  3. Primary completion1 Aug 2018
  4. Study completion1 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03250988
Sponsor's protocol ID
170963
Status last verified
Oct 2018
First submitted
8 Aug 2017
Last updated
9 Oct 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gracies JM. Pathophysiology of spastic paresis. II: Emergence of muscle overactivity. Muscle Nerve. 2005 May;31(5):552-71. doi: 10.1002/mus.20285.

    PubMed 15714511

  • 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.

    PubMed 15774425

  • 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.

    PubMed 14669188

  • 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.

    PubMed 14684785

  • 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.

    PubMed 16446538

  • 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.

    PubMed 7920673

  • 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.

    PubMed 23978464

  • 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.

    PubMed 12540342

  • 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.

    PubMed 26872572

  • 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.

    PubMed 12745703

  • 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.

    PubMed 19191259

  • 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.

    PubMed 21479777

  • 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.

    PubMed 23184421

  • 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.

    PubMed 11454108

Questions about this trial

What is this clinical trial studying?

An observational study of Spasticity, Muscle and Muscular Diseases, run by Vanderbilt University Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of comorbid spasticity and urinary incontinence in a long-term care facility (time frame: Up to three months after consent is obtained). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03250988, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2018.

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