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Fall Risk Assessment in People With Diabetic Neuropathy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stephen D. Jernigan, PT, PhD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01040962
First received: December 28, 2009
Last updated: June 15, 2012
Last verified: June 2012
History of Changes
  Purpose

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
Diabetic Peripheral Neuropathy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Fall Risk Assessment in People With Diabetic Neuropathy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Kansas:

Enrollment: 37
Study Start Date: August 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Falls Risk Assessment, Diabetic Peripheral Neuropathy Patients

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

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Stephen D. Jernigan, PT, PhD, Clinical Assistant Professor, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT01040962     History of Changes
Other Study ID Numbers: 11481, GCRC Protocol #0122
Study First Received: December 28, 2009
Last Updated: June 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
neuropathy
diabetes

Additional relevant MeSH terms:
Diabetic Neuropathies
Peripheral Nervous System Diseases
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Neuromuscular Diseases
 Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on May 19, 2013