Clinical trial NCT01040962: Fall Risk Assessment in People With Diabetic Neuropathy
Official title: Fall Risk Assessment in People With Diabetic Neuropathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Peripheral Neuropathy
Keywords: neuropathy
diabetes
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2009-12-30
Enrollment: 37
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Persons that have diabetic peripheral neuropathy

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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Kansas City
country: United States
facility: North Kansas City Hospital
state: Missouri
Study officials:
affiliation: University of Kansas Medical Center
name: Steve Jernigan
role: PRINCIPAL_INVESTIGATOR
References: