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Clinical Trials/NCT03209960
NCT03209960
Completed
N/A

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

Vanderbilt University Medical Center1 site in 1 country60 target enrollmentJanuary 30, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Spasticity, Muscle
Sponsor
Vanderbilt University Medical Center
Enrollment
60
Locations
1
Primary Endpoint
Sensitivity of Bedside Referral Tool
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 30, 2018
End Date
August 1, 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

David Charles

Professor and Vice-Chairman of Neurology; Chief Medical Officer, Vanderbilt Neuroscience Institute

Vanderbilt University Medical Center

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

  • Spasticity Diagnosis(Up to three months after consent is obtained)
  • Inter-rater Reliability(Up to three months after consent is obtained)
  • Specificity of Bedside Referral Tool(Up to three months after consent is obtained)

Study Sites (1)

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