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Using Telemedicine to Improve Spasticity Diagnosis Rates

Using Telemedicine to Improve Spasticity Diagnosis Rates

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03211390
Enrollment
60
Registered
2017-07-07
Start date
2018-01-30
Completion date
2018-08-01
Last updated
2018-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

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.

DIAGNOSTIC_TESTTeleneurological Examination

A Vanderbilt neurologist will examine all consented residents using a telemedicine platform, with the assistance of a nurse at the subject's bedside. The neurologist will guide the nurse to perform elements of a physical examination to determine if a referral to a movement disorders neurologist is required for a spasticity consultation.

Sponsors

Allergan
CollaboratorINDUSTRY
Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Sensitivity of TeleneurologyUp to three months after consent is obtainedA 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

MeasureTime frameDescription
Specificity of TeleneurologyUp to three months after consent is obtainedA 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.
Spasticity DiagnosisUp to three months after consent is obtainedThere 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026