Fall Risk Assessment in People With Diabetic Neuropathy

NCT ID: NCT01040962

Last Updated: 2012-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

37 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-12-31

Brief Summary

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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

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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.

Conditions

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Diabetic Peripheral Neuropathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Falls Risk Assessment, Diabetic Peripheral Neuropathy Patients

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stephen D. Jernigan, PT, PhD

OTHER

Sponsor Role lead

Responsible Party

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Stephen D. Jernigan, PT, PhD

Clinical Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Steve Jernigan

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

North Kansas City Hospital

Kansas City, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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GCRC Protocol #0122

Identifier Type: OTHER

Identifier Source: secondary_id

11481

Identifier Type: -

Identifier Source: org_study_id

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