Using Telemedicine to Improve Spasticity Diagnosis Rates

Completed

• Conditions: Spasticity, Muscle; Muscular Diseases; Nervous System Diseases; Neurologic Manifestations; Muscle Hypertonia; Signs and Symptoms; Musculoskeletal Disease; Muscle Spasticity; Neuromuscular Manifestations

• Registration Number: NCT03211390
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-07-04
• Study First Submitted QC: 2017-07-04
• Study First Posted: 2017-07-07
• Study Start: 2018-01-30
• Primary Completion: 2018-08-01
• Study Completion: 2018-08-01
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-06
• Last Update Posted: 2018-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity of Teleneurology	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

Name	Time	Method
Spasticity Diagnosis	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.
Specificity of Teleneurology	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.

Trial Locations

Locations (1)

Tennessee State Veterans' Homes; 🇺🇸 Murfreesboro, Tennessee, United States