Reliability of an Algorithm to Diagnose Spasticity



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 100
Updated:4/21/2016
Start Date:April 2013
End Date:January 2016

Use our guide to learn which trials are right for you!

Inter-Rater Reliability of a Spasticity Diagnosis Algorithm

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.

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.

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.
We found this trial at
3
sites
Murfreesboro, Tennessee 37130
?
mi
from
Murfreesboro, TN
Click here to add this to my saved trials
Nashville, Tennessee 37210
?
mi
from
Nashville, TN
Click here to add this to my saved trials
Nashville, Tennessee 37211
?
mi
from
Nashville, TN
Click here to add this to my saved trials