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

Spasticity Clinical Trial

Official title:

Prevalence of Spasticity in Adults With Mental Retardation Residing in a Community Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00282191
• Other study ID #: 051220
• Status: Completed
• Phase: Phase 1
• First received: January 23, 2006
• Last updated: March 26, 2008
• Start date: August 2006
• Est. completion date: August 2007

Study information

• Verified date: March 2008
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult (18 and over) with mental retardation

• Living in a community home in Davidson County, Tennessee.

Exclusion Criteria:

Study Design

Observational Model: Ecologic or Community, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Intellectual Disability
• Mental Retardation
• Muscle Spasticity
• Spasticity

Locations

Country	Name	City	State
United States	Homes	Davidson County	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States,