Clinical trial NCT03209960: Validity and Inter-Rater Reliability of a Novel Bedside Referral Tool for Spasticity
Official title: Validity and Inter-Rater Reliability of a Novel Bedside Referral Tool for Spasticity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spasticity, Muscle
Muscular Diseases
Musculoskeletal Disease
Muscle Hypertonia
Muscle Spasticity
Neuromuscular Manifestations
Signs and Symptoms
Nervous System Diseases
Neurologic Manifestations
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Ipsen
First posted: 2017-07-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nursing home residents

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity of Bedside Referral Tool
timeFrame: Up to three months after consent is obtained
Secondary outcomes:
measure: Specificity of Bedside Referral Tool
timeFrame: Up to three months after consent is obtained
measure: Spasticity Diagnosis
timeFrame: Up to three months after consent is obtained
measure: Inter-rater Reliability
timeFrame: Up to three months after consent is obtained
Other outcomes:
Locations:
city: Murfreesboro
country: United States
facility: Tennessee State Veterans' Homes
state: Tennessee
Study officials:
affiliation: Professor and Vice-Chairman of Neurology
name: David Charles, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gracies JM. Pathophysiology of spastic paresis. II: Emergence of muscle overactivity. Muscle Nerve. 2005 May;31(5):552-71. doi: 10.1002/mus.20285.
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. doi: 10.1136/jnnp.2004.035972. No abstract available.
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. doi: 10.1016/s0003-9993(03)00368-x.
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. doi: 10.1161/01.STR.0000105386.05173.5E. Epub 2003 Dec 18.
citation: 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.
citation: Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977 Mar;33(1):159-74.