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Validity and Inter-Rater Reliability of a Novel Bedside Referral Tool for Spasticity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03209960
Recruitment Status : Completed
First Posted : July 6, 2017
Last Update Posted : October 9, 2018
Sponsor:
Collaborator:
Ipsen
Information provided by (Responsible Party):
David Charles, Vanderbilt University Medical Center

Brief Summary:
The purpose of this study is to improve spasticity diagnosis through development of a simple physical examination guide for primary care providers to identify patients who would benefit from being referred to a movement disorders neurologist for a spasticity evaluation.

Condition or disease Intervention/treatment
Spasticity, Muscle Muscular Diseases Musculoskeletal Disease Muscle Hypertonia Muscle Spasticity Neuromuscular Manifestations Signs and Symptoms Nervous System Diseases Neurologic Manifestations Diagnostic Test: Bedside Referral Tool Other: Neurological Examination

Detailed Description:
The aim of this study is to improve spasticity (a form of muscle rigidity) diagnosis through development of a simple physical examination guide for primary care providers/clinicians. This guide will assist in the identification of patients who would benefit from being referred to a movement disorders neurologist for spasticity evaluation and subsequent treatment. The examination tool will be tested for bedside implementation in all consenting participants residing in Tennessee State Veteran's Home, which is a long-term care facility in Murfreesboro, TN. Each of the 140 residents will receive one neurological examination and two physical examinations guided by the referral tool. A medical record review will also be performed.

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Validity and Inter-Rater Reliability of a Novel Bedside Referral Tool for Spasticity
Actual Study Start Date : January 30, 2018
Actual Primary Completion Date : August 1, 2018
Actual Study Completion Date : August 1, 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Bedside Referral Tool
    Two Vanderbilt primary care providers (a nurse practitioner and a primary care physician) will examine all consented residents. Each primary care provider will perform elements of a physical exam guided by the bedside referral tool to determine if a referral to a movement disorders neurologist is required for a spasticity consultation.
  • Other: Neurological Examination
    The subject will undergo elements of the neurological examination during which the movement disorders neurologist will look specifically for the presence of spasticity. If spasticity is found to be present during the examination, the neurologist will rate the severity of the spasticity in all affected limbs and record whether they would recommend treatment for spasticity, and if so, which treatment(s) they believe would be beneficial for the subject.


Primary Outcome Measures :
  1. Sensitivity of Bedside Referral Tool [ Time Frame: Up to three months after consent is obtained ]
    Two Vanderbilt primary care providers (a nurse practitioner and a primary care physician) will examine all consented residents, guided by the bedside referral tool, to determine if a referral to a movement disorders neurologist is requires for a spasticity consultation. The findings of each exam will be recorded by the research coordinator, who will keep the results blinded from the other raters. Each rater's referral decision will be compared to the diagnosis made by the movement disorders neurologist.


Secondary Outcome Measures :
  1. Specificity of Bedside Referral Tool [ Time Frame: Up to three months after consent is obtained ]
    Two Vanderbilt primary care providers (a nurse practitioner and a primary care physician) will examine all consented residents, guided by the bedside referral tool, to determine if a referral to a movement disorders neurologist is requires for a spasticity consultation. The findings of each exam will be recorded by the research coordinator, who will keep the results blinded from the other raters. Each rater's referral decision will be compared to the diagnosis made by the movement disorders neurologist.

  2. Spasticity Diagnosis [ Time Frame: Up to three months after consent is obtained ]
    There is no biomarker for spasticity. Therefore, the diagnosis will be made on physician impression. A neurologist trained in movement disorders will examine each consented patient to determine if they have spasticity. The severity of the subject's spasticity will be documented, including the following measures: presence of fixed contractures and presence of pain on movement.

  3. Inter-rater Reliability [ Time Frame: Up to three months after consent is obtained ]
    Two Vanderbilt primary care providers (a nurse practitioner and a primary care physician) will examine all consented residents, guided by the bedside referral tool, to determine if a referral to a movement disorders neurologist is requires for a spasticity consultation. The findings of each exam will be recorded by the research coordinator, who will keep the results blinded from the other raters. Agreement on spasticity referral between the two Vanderbilt primary care providers who performed the bedside examination will be determined.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Nursing home residents
Criteria

Inclusion Criteria:

  • Males or female subjects of any race, aged 18 and above
  • Resident of the selected long-term care facility
  • The subject, or if appropriate their medical decision maker, is willing and able to provide written informed consent.

Exclusion Criteria:

  • Subjects for whom participation in the study may cause medical harm

Information from the National Library of Medicine

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): NCT03209960


Locations
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United States, Tennessee
Tennessee State Veterans' Homes
Murfreesboro, Tennessee, United States, 37130
Sponsors and Collaborators
Vanderbilt University Medical Center
Ipsen
Investigators
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Principal Investigator: David Charles, M.D. Professor and Vice-Chairman of Neurology
Publications:
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Responsible Party: David Charles, Professor and Vice-Chairman of Neurology; Chief Medical Officer, Vanderbilt Neuroscience Institute, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03209960    
Other Study ID Numbers: 162074
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Muscle Spasticity
Musculoskeletal Diseases
Muscular Diseases
Nervous System Diseases
Neurologic Manifestations
Muscle Hypertonia
Neuromuscular Manifestations
Neuromuscular Diseases