Using Telemedicine to Improve Spasticity Diagnosis Rates

Nervous System Diseases Clinical Trial

Official title:

Using Telemedicine to Improve Spasticity Diagnosis Rates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03211390
• Other study ID #: 170703
• Status: Completed
• Start date: January 30, 2018
• Est. completion date: August 1, 2018

Study information

• Verified date: October 2018
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 1, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• 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.
• Teleneurological 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.

Locations

Country	Name	City	State
United States	Tennessee State Veterans' Homes	Murfreesboro	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	Allergan

Country where clinical trial is conducted

United States, 

References & Publications (5)

Gracies JM. Pathophysiology of spastic paresis. II: Emergence of muscle overactivity. Muscle Nerve. 2005 May;31(5):552-71. Review. — View Citation

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. — View Citation

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. Epub 2003 Dec 18. — View Citation

Thompson AJ, Jarrett L, Lockley L, Marsden J, Stevenson VL. Clinical management of spasticity. J Neurol Neurosurg Psychiatry. 2005 Apr;76(4):459-63. — View Citation

Welmer AK, von Arbin M, Widén 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. Epub 2006 Jan 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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