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

NCT03209960 | Completed

• 1 other identifier: 162074
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Specificity of Bedside Referral Tool

  Up to three months after consent is obtained

• Spasticity Diagnosis

  Up to three months after consent is obtained

• Inter-rater Reliability

  Up to three months after consent is obtained

Interventions

Bedside Referral Tool DIAGNOSTIC_TEST

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.

Neurological Examination OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Nursing home residents

You may qualify if:

• 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.

You may not qualify if:

• Subjects for whom participation in the study may cause medical harm

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Ipsen: collaborator

Study Sites (1)

Tennessee State Veterans' Homes

Murfreesboro, Tennessee, 37130, United States

Location

Related Publications (6)

• Gracies JM. Pathophysiology of spastic paresis. II: Emergence of muscle overactivity. Muscle Nerve. 2005 May;31(5):552-71. doi: 10.1002/mus.20285.

  PMID: 15714511 BACKGROUND

• 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.

  PMID: 15774425 BACKGROUND

• 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.

  PMID: 14669188 BACKGROUND

• 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.

  PMID: 14684785 BACKGROUND

• 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.

  PMID: 16446538 BACKGROUND

• Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977 Mar;33(1):159-74.

  PMID: 843571 BACKGROUND

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms; Neuromuscular Diseases

Study Officials

• David Charles, M.D.

  Professor and Vice-Chairman of Neurology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Vice-Chairman of Neurology; Chief Medical Officer, Vanderbilt Neuroscience Institute

Study Record Dates

• First Submitted: June 29, 2017
• First Posted: July 6, 2017
• Study Start: January 30, 2018
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: October 9, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)