Using Telemedicine to Improve Spasticity Diagnosis Rates

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.

Study Overview

• Status: Completed
• Conditions: Nervous System Diseases; Neurologic Manifestations; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Spasticity, Muscle; Muscle Spasticity; Musculoskeletal Disease; Signs and Symptoms
• Intervention / Treatment: Diagnostic test: Neurological Examination; Diagnostic test: Teleneurological Examination

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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Murfreesboro, Tennessee, United States, 37130
      • Tennessee State Veterans' Homes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Nursing home residents

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of Teleneurology	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.	Up to three months after consent is obtained

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specificity of Teleneurology	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.	Up to three months after consent is obtained
Spasticity Diagnosis	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.	Up to three months after consent is obtained

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: Allergan

Publications and helpful links

General Publications

• Gracies JM. Pathophysiology of spastic paresis. II: Emergence of muscle overactivity. Muscle Nerve. 2005 May;31(5):552-71. doi: 10.1002/mus.20285.
• Thompson AJ, Jarrett L, Lockley L, Marsden J, Stevenson VL. Clinical management of spasticity. J Neurol Neurosurg Psychiatry. 2005 Apr;76(4):459-63. doi: 10.1136/jnnp.2004.035972. No abstract available.
• Pfister AA, Roberts AG, Taylor HM, Noel-Spaudling S, Damian MM, Charles PD. Spasticity in adults living in a developmental center. Arch Phys Med Rehabil. 2003 Dec;84(12):1808-12. doi: 10.1016/s0003-9993(03)00368-x.
• Sommerfeld DK, Eek EU, Svensson AK, Holmqvist LW, von Arbin MH. Spasticity after stroke: its occurrence and association with motor impairments and activity limitations. Stroke. 2004 Jan;35(1):134-9. doi: 10.1161/01.STR.0000105386.05173.5E. Epub 2003 Dec 18.
• Welmer AK, von Arbin M, Widen Holmqvist L, Sommerfeld DK. Spasticity and its association with functioning and health-related quality of life 18 months after stroke. Cerebrovasc Dis. 2006;21(4):247-53. doi: 10.1159/000091222. Epub 2006 Jan 27.

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2018
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: July 4, 2017
• First Submitted That Met QC Criteria: July 4, 2017
• First Posted (Actual): July 7, 2017

Study Record Updates

• Last Update Posted (Actual): October 9, 2018
• Last Update Submitted That Met QC Criteria: October 6, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Diseases; Muscular Diseases; Muscle Hypertonia; Muscle Spasticity; Neurologic Manifestations; Neuromuscular Manifestations
• Other Study ID Numbers: 170703

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No