Spasticity, MuscleNCT03209960
Validity and Inter-Rater Reliability of a Novel Bedside Referral Tool for Spasticity
An observational study of Spasticity, Muscle and Muscular Diseases, run by Vanderbilt University Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spasticity, Muscle, Muscular Diseases, Musculoskeletal Disease
- What is being tested?
- Bedside Referral Tool and Neurological Examination
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2018to 1 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Nursing home residents
Who may be able to join
- 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.
Who cannot join
- Subjects for whom participation in the study may cause medical harm
Trial locations and contacts
1 site in 1 country.
United States1 site
Tennessee State Veterans' Homes
Murfreesboro, Tennessee, 37130
About this study
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.
Read the 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.
- Conditions
- Spasticity, Muscle, Muscular Diseases, Musculoskeletal Disease, Muscle Hypertonia, Muscle Spasticity, Neuromuscular Manifestations
- Being tested
- Bedside Referral Tool, Neurological Examination
- Medical subject headings
- Muscle Spasticity, Muscular Diseases, Musculoskeletal Diseases, Muscle Hypertonia, Neuromuscular Manifestations, Signs and Symptoms, Nervous System Diseases, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bedside Referral ToolDiagnostic 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 ExaminationOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to three months after consent is obtained
Secondary outcomes (3)
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.
Measured: Up to three months after consent is obtained
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.
Measured: Up to three months after consent is obtained
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.
Measured: Up to three months after consent is obtained
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start30 Jan 2018
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Spasticity, MuscleStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ipsen
- Responsible party
- Principal investigator, David Charles, Vanderbilt University Medical Center
- Investigators
- David Charles, M.D., Principal investigator, Professor and Vice-Chairman of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03209960
- Sponsor's protocol ID
- 162074
- Status last verified
- Oct 2018
- First submitted
- 29 Jun 2017
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gracies JM. Pathophysiology of spastic paresis. II: Emergence of muscle overactivity. Muscle Nerve. 2005 May;31(5):552-71. doi: 10.1002/mus.20285.
PubMed 15714511Thompson 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.
PubMed 15774425Pfister 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.
PubMed 14669188Sommerfeld 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.
PubMed 14684785Welmer 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.
PubMed 16446538Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977 Mar;33(1):159-74.
PubMed 843571
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Inter-Rater Reliability of a Novel Bedside Referral Tool for Spasticity
- ClinicalTrials.gov ID
- NCT03209960
- Acronym / sponsor ID
- 162074
- Conditions
- Spasticity, Muscle, Muscular Diseases, Musculoskeletal Disease, Muscle Hypertonia, Muscle Spasticity, Neuromuscular Manifestations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Ipsen
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 6 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Nursing home residents
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Subjects for whom participation in the study may cause medical harm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bedside Referral ToolTwo 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. | Diagnostic test | – |
| Neurological ExaminationThe 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. | Other | – |
Primary outcome
Sensitivity of Bedside Referral Tool
Time frame: Up to three months after consent is obtained
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.
3 secondary outcomes
Specificity of Bedside Referral Tool
Time frame: Up to three months after consent is obtained
Spasticity Diagnosis
Time frame: Up to three months after consent is obtained
Inter-rater Reliability
Time frame: Up to three months after consent is obtained
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Background: PubMed 15714511Gracies JM. Pathophysiology of spastic paresis. II: Emergence of muscle overactivity. Muscle Nerve. 2005 May;31(5):552-71. doi: 10.1002/mus.20285.
- Background: PubMed 15774425Thompson 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.
- Background: PubMed 14669188Pfister 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.
- Background: PubMed 14684785Sommerfeld 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.
- Background: PubMed 16446538Welmer 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.
- Background: PubMed 843571Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977 Mar;33(1):159-74.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Charles, M.D. principal investigator
Professor and Vice-Chairman of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spasticity, Muscle and Muscular Diseases, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of Bedside Referral Tool (time frame: Up to three months after consent is obtained). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03209960, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2018.