Reliability of an Algorithm to Diagnose Spasticity
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|ClinicalTrials.gov Identifier: NCT01644123|
Recruitment Status : Completed
First Posted : July 18, 2012
Last Update Posted : January 26, 2016
|Condition or disease|
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|
|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|
- 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.
- 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.
- 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.
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 ClinicalTrials.gov 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|
|Principal Investigator:||David Charles, M.D.||Vanderbilt University Medical Center|
|Principal Investigator:||Thomas Davis, M.D.||Vanderbilt University Medical Center|