Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-06-18 @ 4:05 PM
Study NCT ID:
NCT03209960
Status:
COMPLETED
Last Update Posted:
2018-10-09
First Post:
2017-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validity and Inter-Rater Reliability of a Novel Bedside Referral Tool for Spasticity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009128', 'term': 'Muscle Spasticity'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009122', 'term': 'Muscle Hypertonia'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}], 'ancestors': [{'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-06', 'studyFirstSubmitDate': '2017-06-29', 'studyFirstSubmitQcDate': '2017-07-03', 'lastUpdatePostDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity of Bedside Referral Tool', 'timeFrame': 'Up to three months after consent is obtained', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Specificity of Bedside Referral Tool', 'timeFrame': 'Up to three months after consent is obtained', 'description': "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."}, {'measure': 'Spasticity Diagnosis', 'timeFrame': 'Up to three months after consent is obtained', 'description': "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."}, {'measure': 'Inter-rater Reliability', 'timeFrame': 'Up to three months after consent is obtained', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spasticity, Muscle', 'Muscular Diseases', 'Musculoskeletal Disease', 'Muscle Hypertonia', 'Muscle Spasticity', 'Neuromuscular Manifestations', 'Signs and Symptoms', 'Nervous System Diseases', 'Neurologic Manifestations']}, 'referencesModule': {'references': [{'pmid': '15714511', 'type': 'BACKGROUND', '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.'}, {'pmid': '15774425', 'type': 'BACKGROUND', '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.'}, {'pmid': '14669188', 'type': 'BACKGROUND', '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.'}, {'pmid': '14684785', 'type': 'BACKGROUND', '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.'}, {'pmid': '16446538', 'type': 'BACKGROUND', '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.'}, {'pmid': '843571', 'type': 'BACKGROUND', 'citation': 'Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977 Mar;33(1):159-74.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Nursing home residents', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or female subjects of any race, aged 18 and above\n* Resident of the selected long-term care facility\n* The subject, or if appropriate their medical decision maker, is willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Subjects for whom participation in the study may cause medical harm'}, 'identificationModule': {'nctId': 'NCT03209960', 'briefTitle': 'Validity and Inter-Rater Reliability of a Novel Bedside Referral Tool for Spasticity', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Validity and Inter-Rater Reliability of a Novel Bedside Referral Tool for Spasticity', 'orgStudyIdInfo': {'id': '162074'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Bedside Referral Tool', 'type': 'DIAGNOSTIC_TEST', 'description': '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.'}, {'name': 'Neurological Examination', 'type': 'OTHER', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '37130', 'city': 'Murfreesboro', 'state': 'Tennessee', 'country': 'United States', 'facility': "Tennessee State Veterans' Homes", 'geoPoint': {'lat': 35.84562, 'lon': -86.39027}}], 'overallOfficials': [{'name': 'David Charles, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor and Vice-Chairman of Neurology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ipsen', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Vice-Chairman of Neurology; Chief Medical Officer, Vanderbilt Neuroscience Institute', 'investigatorFullName': 'David Charles', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}