Fall Risk Assessment in People With Diabetic Neuropathy

Completed

• Conditions: Diabetic Peripheral Neuropathy

• Registration Number: NCT01040962
• Lead Sponsor: Stephen D. Jernigan, PT, PhD

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2009-12-28
• Study First Submitted QC: 2009-12-29
• Study First Posted: 2009-12-30
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-15
• Last Update Posted: 2012-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (2)

North Kansas City Hospital; 🇺🇸 Kansas City, Missouri, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States