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Prevalence of Spasticity in Adults With Mental Retardation Living in the Community

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00282191
Recruitment Status : Completed
First Posted : January 25, 2006
Last Update Posted : March 28, 2008
Sponsor:
Information provided by:
Vanderbilt University

Tracking Information
First Submitted Date January 23, 2006
First Posted Date January 25, 2006
Last Update Posted Date March 28, 2008
Study Start Date August 2006
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prevalence of Spasticity in Adults With Mental Retardation Living in the Community
Official Title Prevalence of Spasticity in Adults With Mental Retardation Residing in a Community Setting
Brief Summary This survey aims to investigate the prevalence of spasticity among adults who live in community settings in Davidson County, Tennessee. The treatment of spasticity in those who live in community homes could significantly increase a person's quality of life by allowing them to participate more independently in activities of daily living, or by making assistance easier for caregivers.
Detailed Description

The process of deinstitutionalization has transitioned a large majority of persons with developmental disabilities into the community over the past several decades, and that number will only increase going forward. There are 926 people in this region who are provided assistance through the Division of Mental Retardation Services (DMRS). People with developmental disabilities frequently have comorbidities such as spasticity that hinder their ability to participate in activities of daily living. Spasticity results from brain or spinal cord injury and can produce increased muscle tone, causing joint stiffness, contractures and pain that can interfere with recommended treatment. A previous survey conducted at Clover Bottom Developmental Center investigated care areas typically affected by spasticity, including splinting, hygiene, dressing, transfers, positioning, ambulation, and engaging in other functional activities. Pfister et al. reported the prevalence of spasticity in the developmental center to be 35% (72/205); of those people, the Survey Physician felt that 75% (54/72) would achieve a functional benefit from treatment.

Primary endpoints will assess the prevalence of spasticity in adults who reside in the community, and whether or not spasticity impacts activities of daily living. When appropriate, potential care area goals will be identified, and treatment options will be recorded. Secondary endpoints will examine whether or not participants currently receive treatment for spasticity; if so, what treatment is being used; and which care areas are most impacted by spasticity.

Study Type Observational
Study Design Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Adults with mental retardation living in community homes in Davidson County, TN.
Condition
  • Mental Retardation
  • Spasticity
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 26, 2008)
7
Original Enrollment
 (submitted: January 23, 2006)
88
Actual Study Completion Date August 2007
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Adult (18 and over) with mental retardation
  • Living in a community home in Davidson County, Tennessee.

Exclusion Criteria:

None.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00282191
Other Study ID Numbers 051220
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party David Charles, M.D., Vanderbilt University Medical Center Department of Neurology
Study Sponsor Vanderbilt University
Collaborators Not Provided
Investigators
Principal Investigator: David Charles, MD Vanderbilt University Department of Neurology
PRS Account Vanderbilt University
Verification Date March 2008