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Prevalence of Spasticity in Adults With Mental Retardation Living in the Community
This study has been completed.
Sponsored by: Vanderbilt University
Information provided by: Vanderbilt University
ClinicalTrials.gov Identifier: NCT00282191
  Purpose

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.


Condition Phase
Mental Retardation
Spasticity
Phase I

U.S. FDA Resources
Study Type: Observational
Study Design: Ecologic or Community, Cross-Sectional
Official Title: Prevalence of Spasticity in Adults With Mental Retardation Residing in a Community Setting

Further study details as provided by Vanderbilt University:

Biospecimen Retention:   None Retained

Biospecimen Description:

Enrollment: 7
Study Start Date: August 2006
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Adults with mental retardation living in community homes in Davidson County, TN.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

None.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00282191

Locations
United States, Tennessee
Homes
Davidson County, Tennessee, United States
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: David Charles, MD Vanderbilt University Department of Neurology
  More Information

Responsible Party: Vanderbilt University Medical Center Department of Neurology ( David Charles, M.D. )
Study ID Numbers: 051220
Study First Received: January 23, 2006
Last Updated: March 26, 2008
ClinicalTrials.gov Identifier: NCT00282191  
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
spasticity
mental retardation

Study placed in the following topic categories:
Mental Retardation
Signs and Symptoms
Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Mental Disorders
Mental Disorders Diagnosed in Childhood
Neurologic Manifestations
Neurobehavioral Manifestations

Additional relevant MeSH terms:
Neuromuscular Manifestations
Nervous System Diseases

ClinicalTrials.gov processed this record on January 30, 2009