Reliability of an Algorithm to Diagnose Spasticity

This study is currently recruiting participants.
Verified June 2013 by Vanderbilt University
Sponsor:
Collaborator:
Merz Pharmaceuticals, LLC
Information provided by (Responsible Party):
David Charles, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01644123
First received: July 16, 2012
Last updated: June 11, 2013
Last verified: June 2013
  Purpose

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
Spasticity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Inter-Rater Reliability of a Spasticity Diagnosis Algorithm

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Inter-rater reliability of a spasticity diagnosis algorithm when used by two movement disorder specialists. [ Time Frame: One year ] [ Designated as safety issue: No ]
    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:
  • To compare the prevalence of spasticity between three nursing homes in Davidson County, Tennessee. [ Time Frame: One year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    We will survey enrolled subjects to determine if they are aware of available treatments for spasticity.


Estimated Enrollment: 100
Study Start Date: April 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Nursing home residents

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Nursing home residents

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01644123

Contacts
Contact: Anna Molinari, B.A. 615-343-6446 anna.l.molinari@vanderbilt.edu
Contact: Odessa Lankford 615-343-2961 odessa.lankford@vanderbilt.edu

Locations
United States, Tennessee
Tennessee State Veterans Home Recruiting
Murfreesboro, Tennessee, United States, 37130
Contact: Tyler Masden    615-895-8850      
Bethany Health & Rehabilitation Center Not yet recruiting
Nashville, Tennessee, United States, 37211
Contact: Ralf Habermann, MD         
Trevecca Health & Rehab Not yet recruiting
Nashville, Tennessee, United States, 37210
Contact: Ralf Habermann, MD         
Sponsors and Collaborators
Vanderbilt University
Merz Pharmaceuticals, LLC
Investigators
Principal Investigator: David Charles, M.D. Vanderbilt University
Principal Investigator: Thomas Davis, M.D. Vanderbilt University
  More Information

Publications:
Responsible Party: David Charles, Vice-Chairman, Department of Neurology; Chief Medical Officer, Vanderbilt Neuroscience Institute, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01644123     History of Changes
Other Study ID Numbers: 090361, 090361
Study First Received: July 16, 2012
Last Updated: June 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Spasticity
Diagnostic Algorithm

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

ClinicalTrials.gov processed this record on April 14, 2014