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Using Telemedicine to Improve Spasticity Diagnosis Rates

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified July 2017 by David Charles, Vanderbilt University Medical Center
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
David Charles, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:
NCT03211390
First received: July 4, 2017
Last updated: NA
Last verified: July 2017
History: No changes posted
  Purpose
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 Intervention
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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Using Telemedicine to Improve Spasticity Diagnosis Rates

Further study details as provided by David Charles, Vanderbilt University Medical Center:

Primary Outcome Measures:
  • 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:
  • 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.

  • 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.


Estimated Enrollment: 140
Anticipated Study Start Date: August 1, 2017
Estimated Study Completion Date: August 1, 2018
Estimated Primary Completion Date: August 1, 2018 (Final data collection date for primary outcome measure)
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.
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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03211390

Contacts
Contact: David Charles, M.D. 615-322-2538 david.charles@vanderbilt.edu

Locations
United States, Tennessee
Tennessee State Veterans' Homes Not yet recruiting
Murfreesboro, Tennessee, United States, 37130
Contact: Tyler Masden    615-895-8850    tmasden@tsvh.org   
Principal Investigator: David Charles, M.D.         
Sponsors and Collaborators
Vanderbilt University Medical Center
Allergan
Investigators
Principal Investigator: David Charles, M.D. Vanderbilt University Medical Center
  More Information

Publications:
Responsible Party: David Charles, Professor and Vice-Chairman of Neurology, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03211390     History of Changes
Other Study ID Numbers: 170703
Study First Received: July 4, 2017
Last Updated: July 4, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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

ClinicalTrials.gov processed this record on July 11, 2017