NCT01879449

Brief Summary

The purpose of the study is to conduct a feasibility survey of the prevalence of spasticity at a single long-term care facility for veterans and their spouses in Murfreesboro, Tennessee. These data will be used to strengthen a future grant application to the Department of Defense in response to their ongoing Traumatic Brain Injury initiative.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 17, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

January 26, 2016

Status Verified

January 1, 2016

Enrollment Period

1.2 years

First QC Date

June 12, 2013

Last Update Submit

January 25, 2016

Conditions

Spasticity

Keywords

SpasticityVeteransPrevalence

Outcome Measures

Primary Outcomes (1)

  • 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 veteran's spasticity will be documented, including the following measures: presence of fixed contractures and presence of pain on movement.

    Up to three months after consent is obtained

Secondary Outcomes (1)

  • Spasticity treatment awareness and preferences survey

    Up to three months after consent is obtained

Eligibility Criteria

Age18 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 at the Tennessee State Veterans Home

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 (1)

Tennessee State Veterans Home

Murfreesboro, Tennessee, 37130, United States

Location

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

    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-Chair, Department of Neurology

Study Record Dates

First Submitted

June 12, 2013

First Posted

June 17, 2013

Study Start

February 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

January 26, 2016

Record last verified: 2016-01

Locations

US(1)