Reliability of an Algorithm to Diagnose Spasticity

Study Description

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Brief Summary:

Spasticity is a condition that results from damage to the central nervous system and causes painful muscle contractures that drastically affect level of independence, activities of daily living, and quality of life. Although there are well-known and accepted treatments for spasticity, spasticity is often left undertreated; the specific reasons for this observation are unknown. Because there is no blood test or scan that indicates the presence of spasticity, diagnosis is based entirely on physician impression. Therefore, the investigators hypothesize that one reason that spasticity is undertreated is due to the lack of a standardized diagnostic procedure. This study attempts to test the reliability of a diagnostic flowchart that seeks to increase the accuracy of physician diagnosis of spasticity.

Condition or disease
Spasticity

Detailed Description:

Spasticity is defined as a velocity-dependent increase in stretch reflex with muscle overactivity, and is associated with involuntary limb movements or spasms which can often be painful. Active function (such as walking, driving, writing, or sexual activity) can be adversely affected by spasticity. For patients with significant disability requiring a caregiver, passive function (such as facilitation of bathing, dressing, and undergarment change) can also become very difficult, especially when spasticity is left untreated. Finally, persistent involuntary motion or spasms may negatively impact an individual's mood or self image, making social situations more difficult and sometimes overwhelming.

Spasticity is especially undertreated in vulnerable populations; population surveys in individuals with intellectual disability and nursing home residents have shown that less than 20% of affected individuals are treated. There are severe negative consequences of leaving spasticity untreated, like muscle shortening and tendon and soft tissue contractures. Once developed, contractures are very difficult to treat and can hinder personal hygiene and dressing, and well as the ability to sit or lie properly. Bad hygiene and immobility can lead, in turn, to urinary tract infections, pressure ulcers and skin breakdown. Furthermore, spasticity can stunt muscle growth and cause abnormal bone growth and formation, especially in children.

Spasticity is diagnosed based upon a physician's clinical impression; there is currently no biomarker to facilitate an objective diagnosis. The two instruments most commonly used to document severity are the Modified Ashworth Scale and Range of Motion Assessment. Both assessments are based upon a clinician's assessment of muscle tone, but there is no widely-accepted protocol to determine the presence of spasticity. We therefore hypothesize one reason spasticity is widely undertreated is the challenge faced by physicians when attempting to make a diagnosis. In the absence of a biomarker, a more standardized method of clinical diagnosis is necessary, both for future research and for advocacy efforts. The treatment of spasticity could increase quality of life by allowing an individual to participate more independently in activities of daily living, and by making assistance easier for caregivers.

Study Design

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Study Type :	Observational
Actual Enrollment :	72 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Inter-Rater Reliability of a Spasticity Diagnosis Algorithm
Study Start Date :	April 2013
Actual Primary Completion Date :	January 2016
Actual Study Completion Date :	January 2016

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Nursing home residents

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Inter-rater reliability of a spasticity diagnosis algorithm when used by two movement disorder specialists. [ Time Frame: One year ]
   Two movement disorders specialists will independently use the flowchart while performing physical and neurological examinations on enrolled patients to determine whether spasticity is present.

Secondary Outcome Measures :

1. To compare the prevalence of spasticity between three nursing homes in Davidson County, Tennessee. [ Time Frame: One year ]
   We will attempt to estimate the prevalence of spasticity in the nursing home setting based on the prevalence observed in 3 randomly selected nursing homes in Middle Tennessee.
2. Awareness of different spasticity treatments and treatment preferences (if treatment is applicable) based on a Treatment Preferences Survey. [ Time Frame: One year ]
   We will survey enrolled subjects to determine if they are aware of available treatments for spasticity.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 100 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Nursing home residents

Criteria

Inclusion Criteria:

• Male and female subjects of any race, aged 18 and above.
• Reside in one of the five selected long term care facilities.

Exclusion Criteria:

• Subjects for whom it is felt that participation in the study would cause medical harm.

Contacts and Locations

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Locations

United States, Tennessee
Tennessee State Veterans Home
Murfreesboro, Tennessee, United States, 37130
Trevecca Health & Rehab
Nashville, Tennessee, United States, 37210
Bethany Health & Rehabilitation Center
Nashville, Tennessee, United States, 37211

Sponsors and Collaborators

Vanderbilt University

Merz North America, Inc.

Investigators

Principal Investigator:	David Charles, M.D.	Vanderbilt University Medical Center
Principal Investigator:	Thomas Davis, M.D.	Vanderbilt University Medical Center

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Charles PD, Gill CE, Taylor HM, Putman MS, Blair CR, Roberts AG, Ayers GD, Konrad PE. Spasticity treatment facilitates direct care delivery for adults with profound intellectual disability. Mov Disord. 2010 Mar 15;25(4):466-73. doi: 10.1002/mds.22995.

Gill CE, Andrade EO, Blair CR, Taylor HM, Charles D. Combined treatment with BTX-A and ITB for spasticity: case report. Tenn Med. 2007 Oct;100(10):41-2, 44.

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.

Responsible Party:	David Charles, Vice-Chairman, Department of Neurology; Chief Medical Officer, Vanderbilt Neuroscience Institute, Vanderbilt University
ClinicalTrials.gov Identifier:	NCT01644123 History of Changes
Other Study ID Numbers:	090361; 090361 ( Other Identifier: Vanderbilt IRB )
First Posted:	July 18, 2012
Last Update Posted:	January 26, 2016
Last Verified:	January 2016

Keywords provided by David Charles, Vanderbilt University:

Spasticity; Diagnostic Algorithm

Additional relevant MeSH terms:

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