Diabetic Peripheral NeuropathyNCT01040962
Fall Risk Assessment in People With Diabetic Neuropathy
An observational study of Diabetic Peripheral Neuropathy, run by Stephen D. Jernigan, PT, PhD at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- How many people
- 37 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2008to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Persons that have diabetic peripheral neuropathy
Who may be able to join
- diagnosed with diabetic peripheral neuropathy
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Kansas Medical Center
Kansas City, Kansas, 66160
North Kansas City Hospital
Kansas City, Missouri, 64116
About this study
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.
Read the 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.
- Conditions
- Diabetic Peripheral Neuropathy
- Keywords
- neuropathy, diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Falls Risk Assessment, Diabetic Peripheral Neuropathy Patients | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2009 (estimated)
- Study startAug 2008
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stephen D. Jernigan, PT, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stephen D. Jernigan, PT, PhD, University of Kansas Medical Center
- Investigators
- Steve Jernigan, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01040962
- Sponsor's protocol ID
- 11481
- Other IDs
- GCRC Protocol #0122
- Status last verified
- Jun 2012
- First submitted
- 28 Dec 2009
- Last updated
- 19 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fall Risk Assessment in People With Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT01040962
- Acronym / sponsor ID
- 11481
- Conditions
- Diabetic Peripheral Neuropathy
- Keywords
- neuropathy, diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Stephen D. Jernigan, PT, PhDUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 30 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Falls Risk Assessment, Diabetic Peripheral Neuropathy Patients | – | – |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Persons that have diabetic peripheral neuropathy
Key inclusion criteria (1 listed)
- diagnosed with diabetic peripheral neuropathy
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steve Jernigan principal investigator
University of Kansas Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Peripheral Neuropathy, run by Stephen D. Jernigan, PT, PhD at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2012.