- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01644123
Reliability of an Algorithm to Diagnose Spasticity
Inter-Rater Reliability of a Spasticity Diagnosis Algorithm
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Tennessee
-
Murfreesboro, Tennessee, United States, 37130
- Tennessee State Veterans Home
-
Nashville, Tennessee, United States, 37210
- Trevecca Health & Rehab
-
Nashville, Tennessee, United States, 37211
- Bethany Health & Rehabilitation Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Nursing home residents
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
One year
|
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.
|
One year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Thomas Davis, M.D., Vanderbilt University Medical Center
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 090361 (Other Identifier: Vanderbilt IRB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Spasticity
-
Vancouver Island Health AuthorityRecruiting
-
Universitatea de Medicina si Farmacie Iuliu HatieganuRecruiting
-
Nantes University HospitalCompiègne University of TechnologyCompleted
-
Fondation Ophtalmologique Adolphe de RothschildNot yet recruitingSpasticity, Muscle
-
Piramal Critical Care, Ltd.CompletedSevere SpasticityUnited States
-
University of AlbertaRecruiting
-
Ospedale Generale Di Zona Moriggia-PelasciniSuspended
-
IpsenRecruitingUpper Limb SpasticityUnited States, France, Canada, Puerto Rico
-
IRCCS Sacro Cuore Don Calabria di NegrarRecruiting
-
Pacira Pharmaceuticals, IncCompletedUpper Limb SpasticityUnited States