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

Nervous System Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03209960
• Other study ID #: 162074
• 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 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.

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.

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:

• 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

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:
• 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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	Ipsen

Country where clinical trial is conducted

United States, 

References & Publications (6)

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

Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977 Mar;33(1):159-74. — 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 Bedside Referral Tool	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.	Up to three months after consent is obtained
Secondary	Specificity of Bedside Referral Tool	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.	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
Secondary	Inter-rater Reliability	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. Agreement on spasticity referral between the two Vanderbilt primary care providers who performed the bedside examination will be determined.	Up to three months after consent is obtained