Fall Risk Assessment in People With Diabetic Neuropathy

Diabetic Peripheral Neuropathy Clinical Trial

Official title:

Fall Risk Assessment in People With Diabetic Neuropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01040962
• Other study ID #: 11481
• Secondary ID: GCRC Protocol #0
• Status: Completed
• Phase: N/A
• First received: December 28, 2009
• Last updated: June 15, 2012
• Start date: August 2008
• Est. completion date: December 2010

Study information

• Verified date: June 2012
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Fall risk is increased in people with diabetic peripheral neuropathy (DPN) and yet, minimal research has been conducted to identify appropriate fall risk assessment tools and improve our understanding of falls in these individuals. Purpose: The primary purpose of this study is to establish a foundation of knowledge needed to address falls in people with DPN. This will be accomplished through 1) comparing the validity of 4 fall risk assessment tools, 2) identifying risk factors for falls and 3) determining how quality of life is influenced by factors related to falls in people with DPN.

Description:

All subjects participate in testing that involves questionnaires, cognitive testing, fall risk assessment, and other testing related to physical parameters including body mass index, glycosylated hemoglobin, lower extremity nerve conduction study, and ankle range of motion, proprioception and strength. After testing, subjects are interviewed to determine fall status (faller or non-faller). A "faller" is defined as someone that has fallen at least 2 times in the past year. Data Analysis: The validity of the fall risk assessment tools will be compared using sensitivity and specificity analyses. Variables related to ankle function, neuropathy, glycemic control and general activity will be analyzed for association with recent fall history through multivariable logistic regression. Variables related to falls, neuropathy and activity level will be analyzed for association with health-related quality of life through multivariable linear regression.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

• diagnosed with diabetic peripheral neuropathy

Exclusion Criteria:

• major medical depression

• non-diabetes related musculoskeletal problems that limit ambulation

• open wounds on the weight bearing surfaces of the feet

• requires another person's assistance to walk

• uncorrected visual deficits that influence gait and/or balance

• history of stroke or other CNS pathology that impairs gait and/or balance

• diagnosed untreated vestibular disorder that results in gait and/or balance disturbances

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Peripheral Neuropathy
• Peripheral Nervous System Diseases

Locations

Country	Name	City	State
United States	North Kansas City Hospital	Kansas City	Missouri
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Stephen D. Jernigan, PT, PhD

Country where clinical trial is conducted

United States,