Reliability of an Algorithm to Diagnose Spasticity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01644123
Recruitment Status : Completed
First Posted : July 18, 2012
Last Update Posted : January 26, 2016
Merz North America, Inc.
Information provided by (Responsible Party):
David Charles, Vanderbilt University

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

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 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

Nursing home residents

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.

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01644123

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

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

Keywords provided by David Charles, Vanderbilt University:
Diagnostic Algorithm

Additional relevant MeSH terms:
Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms