Clinical trial NCT01644123: Reliability of an Algorithm to Diagnose Spasticity
Official title: Inter-Rater Reliability of a Spasticity Diagnosis Algorithm
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spasticity
Keywords: Spasticity
Diagnostic Algorithm
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: Merz North America, Inc.
First posted: 2012-07-18
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nursing home residents

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.

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.

Eligibility 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.

Primary outcomes:
measure: Inter-rater reliability of a spasticity diagnosis algorithm when used by two movement disorder specialists.
timeFrame: One year
Secondary outcomes:
measure: To compare the prevalence of spasticity between three nursing homes in Davidson County, Tennessee.
timeFrame: One year
measure: Awareness of different spasticity treatments and treatment preferences (if treatment is applicable) based on a Treatment Preferences Survey.
timeFrame: One year
Other outcomes:
Locations:
city: Murfreesboro
country: United States
facility: Tennessee State Veterans Home
state: Tennessee
city: Nashville
country: United States
facility: Trevecca Health & Rehab
state: Tennessee
city: Nashville
country: United States
facility: Bethany Health & Rehabilitation Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: David Charles, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University Medical Center
name: Thomas Davis, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.