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

NCT03209960 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2018-10-09

No results posted yet for this study

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.

Conditions

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

Interventions

DIAGNOSTIC_TEST

Bedside Referral Tool

Two Vanderbilt primary care providers (a nurse practitioner and a primary care physician) will examine all consented residents. Each primary care provider will perform elements of a physical exam guided by the bedside referral tool to determine if a referral to a movement disorders neurologist is required for a spasticity consultation.

OTHER

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.

Sponsors & Collaborators

  • Ipsen

    collaborator INDUSTRY
  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • David Charles, M.D. · Professor and Vice-Chairman of Neurology

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-30
Primary Completion
2018-08-01
Completion
2018-08-01

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03209960 on ClinicalTrials.gov