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

Completed

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

• Registration Number: NCT03209960
• Lead Sponsor: 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.

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.

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: 2017-06-29
• Study First Submitted QC: 2017-07-03
• Study First Posted: 2017-07-06
• 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

• 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.

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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 Bedside Referral Tool	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

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.
Inter-rater Reliability	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.
Specificity of Bedside Referral Tool	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.

Trial Locations

Locations (1)

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