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Using Telemedicine to Improve Spasticity Diagnosis Rates

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: NCT03211390
Recruitment Status : Completed
First Posted : July 7, 2017
Last Update Posted : October 9, 2018
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
David Charles, Vanderbilt University Medical Center

Brief Summary:
The purpose of this study is to test the reliability of using telemedicine so a neurologist can remotely identify residents of a long-term care facility who should be referred to a neurologist for an in-person spasticity consultation.

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: Neurological Examination Diagnostic Test: Teleneurological Examination

Detailed Description:
The aim of this study is to improve spasticity (a form of muscle rigidity) diagnosis through validation of telemedicine as a tool for spasticity evaluation or referral. This study will test the reliability of using telemedicine so a neurologist can remotely identify residents of a long-term care facility who should be referred to a neurologist for an in-person spasticity consultation. The telemedicine referral 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 one physical examination guided by the teleneurologist. 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: Using Telemedicine to Improve Spasticity Diagnosis Rates
Actual Study Start Date : January 30, 2018
Actual Primary Completion Date : August 1, 2018
Actual Study Completion Date : August 1, 2018

Intervention Details:
  • Diagnostic Test: 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.
  • Diagnostic Test: Teleneurological Examination
    A Vanderbilt neurologist will examine all consented residents using a telemedicine platform, with the assistance of a nurse at the subject's bedside. The neurologist will guide the nurse to perform elements of a physical examination to determine if a referral to a movement disorders neurologist is required for a spasticity consultation.


Primary Outcome Measures :
  1. Sensitivity of Teleneurology [ Time Frame: Up to three months after consent is obtained ]
    A Vanderbilt neurologist will examine all consented residents for spasticity using a telemedicine platform, with the assistance of a nurse at the subject's bedside. The findings of the exam will be recorded by the research coordinator. Agreement on spasticity referral between the Vanderbilt neurologist who performed the teleneurological examination and the neurologist who performed the "gold standard" examination will be determined.


Secondary Outcome Measures :
  1. Specificity of Teleneurology [ Time Frame: Up to three months after consent is obtained ]
    A Vanderbilt neurologist will examine all consented residents for spasticity using a telemedicine platform, with the assistance of a nurse at the subject's bedside. The findings of the exam will be recorded by the research coordinator. Agreement on spasticity referral between the Vanderbilt neurologist who performed the teleneurological examination and the neurologist who performed the "gold standard" examination will be determined.

  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.



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:

  • Male 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): NCT03211390


Locations
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United States, Tennessee
Tennessee State Veterans' Homes
Murfreesboro, Tennessee, United States, 37130
Sponsors and Collaborators
Vanderbilt University Medical Center
Allergan
Investigators
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Principal Investigator: David Charles, M.D. Vanderbilt University Medical Center
Publications:
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Responsible Party: David Charles, Professor and Vice-Chairman of Neurology, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03211390    
Other Study ID Numbers: 170703
First Posted: July 7, 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
Muscular Diseases
Neurologic Manifestations
Muscle Hypertonia
Neuromuscular Manifestations
Nervous System Diseases
Signs and Symptoms
Musculoskeletal Diseases
Neuromuscular Diseases