NCT01644123

Brief Summary

Spasticity is a condition that results from damage to the central nervous system and causes painful muscle contractures that drastically affect level of independence, activities of daily living, and quality of life. Although there are well-known and accepted treatments for spasticity, spasticity is often left undertreated; the specific reasons for this observation are unknown. Because there is no blood test or scan that indicates the presence of spasticity, diagnosis is based entirely on physician impression. Therefore, the investigators hypothesize that one reason that spasticity is undertreated is due to the lack of a standardized diagnostic procedure. This study attempts to test the reliability of a diagnostic flowchart that seeks to increase the accuracy of physician diagnosis of spasticity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2013

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2012

Completed
9 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 26, 2016

Status Verified

January 1, 2016

Enrollment Period

2.8 years

First QC Date

July 16, 2012

Last Update Submit

January 25, 2016

Conditions

Spasticity

Keywords

SpasticityDiagnostic Algorithm

Outcome Measures

Primary Outcomes (1)

  • Inter-rater reliability of a spasticity diagnosis algorithm when used by two movement disorder specialists.

    Two movement disorders specialists will independently use the flowchart while performing physical and neurological examinations on enrolled patients to determine whether spasticity is present.

    One year

Secondary Outcomes (2)

  • To compare the prevalence of spasticity between three nursing homes in Davidson County, Tennessee.

    One year

  • Awareness of different spasticity treatments and treatment preferences (if treatment is applicable) based on a Treatment Preferences Survey.

    One year

Study Arms (1)

Nursing home residents

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Nursing home residents

You may qualify if:

  • Male and female subjects of any race, aged 18 and above.
  • Reside in one of the five selected long term care facilities.

You may not qualify if:

  • Subjects for whom it is felt that participation in the study would cause medical harm.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Tennessee State Veterans Home

Murfreesboro, Tennessee, 37130, United States

Location

Trevecca Health & Rehab

Nashville, Tennessee, 37210, United States

Location

Bethany Health & Rehabilitation Center

Nashville, Tennessee, 37211, United States

Location

Related Publications (3)

  • Charles PD, Gill CE, Taylor HM, Putman MS, Blair CR, Roberts AG, Ayers GD, Konrad PE. Spasticity treatment facilitates direct care delivery for adults with profound intellectual disability. Mov Disord. 2010 Mar 15;25(4):466-73. doi: 10.1002/mds.22995.

    PMID: 20131401BACKGROUND

  • Gill CE, Andrade EO, Blair CR, Taylor HM, Charles D. Combined treatment with BTX-A and ITB for spasticity: case report. Tenn Med. 2007 Oct;100(10):41-2, 44.

    PMID: 17966716BACKGROUND

  • 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: 14669188BACKGROUND

MeSH Terms

Conditions

Muscle Spasticity

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • David Charles, M.D.

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

  • Thomas Davis, M.D.

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice-Chairman, Department of Neurology; Chief Medical Officer, Vanderbilt Neuroscience Institute

Study Record Dates

First Submitted

July 16, 2012

First Posted

July 18, 2012

Study Start

April 1, 2013

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

January 26, 2016

Record last verified: 2016-01

Locations

US(3)