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

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ClinicalTrials.gov Identifier: NCT00282191
Recruitment Status : Completed
First Posted : January 25, 2006
Last Update Posted : March 28, 2008
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Phase
Mental Retardation Spasticity Phase 1

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 Design

Study Type : Observational
Actual Enrollment : 7 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: Prevalence of Spasticity in Adults With Mental Retardation Residing in a Community Setting
Study Start Date : August 2006
Primary Completion Date : August 2007
Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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: David Charles, M.D., Vanderbilt University Medical Center Department of Neurology
ClinicalTrials.gov Identifier: NCT00282191     History of Changes
Other Study ID Numbers: 051220
First Posted: January 25, 2006    Key Record Dates
Last Update Posted: March 28, 2008
Last Verified: March 2008

Keywords provided by Vanderbilt University:
spasticity
mental retardation

Additional relevant MeSH terms:
Muscle Spasticity
Intellectual Disability
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurobehavioral Manifestations
Neurodevelopmental Disorders
Mental Disorders