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Fall Risk Assessment in People With Diabetic Neuropathy

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ClinicalTrials.gov Identifier: NCT01040962
Recruitment Status : Completed
First Posted : December 30, 2009
Last Update Posted : June 19, 2012
Sponsor:
Information provided by (Responsible Party):
Stephen D. Jernigan, PT, PhD, University of Kansas Medical Center

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.

Condition or disease
Diabetic Peripheral Neuropathy

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 Type : Observational
Actual Enrollment : 37 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Fall Risk Assessment in People With Diabetic Neuropathy
Study Start Date : August 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


Group/Cohort
Falls Risk Assessment, Diabetic Peripheral Neuropathy Patients




Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Persons that have diabetic peripheral neuropathy
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01040962


Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Missouri
North Kansas City Hospital
Kansas City, Missouri, United States, 64116
Sponsors and Collaborators
Stephen D. Jernigan, PT, PhD
Investigators
Principal Investigator: Steve Jernigan University of Kansas Medical Center

Responsible Party: Stephen D. Jernigan, PT, PhD, Clinical Assistant Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT01040962     History of Changes
Other Study ID Numbers: 11481
GCRC Protocol #0122 ( Other Identifier: University of Kansas Medical Center )
First Posted: December 30, 2009    Key Record Dates
Last Update Posted: June 19, 2012
Last Verified: June 2012

Keywords provided by Stephen D. Jernigan, PT, PhD, University of Kansas Medical Center:
neuropathy
diabetes

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases