DiabetesNCT00223782
Motor Learning in Gait in Subjects With Diabetic Peripheral Neuropathy
A study testing Gait Training with Feedback and Gait Training with no feedback in people with Diabetes and Peripheral Neuropathy, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The purpose of this study is to determine whether individuals with diabetic peripheral neuropathy can learn to change the way they walk in order to reduce the pressures underneath the feet, which may lead to a reduced risk of foot ulceration. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Diabetes, Peripheral Neuropathy
- What is being tested?
- Gait Training with Feedback and Gait Training with no feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to Sep 2006
- Phase
- Interventional
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of diabetes for at least one year.
- Diabetic peripheral neuropathy as defined by failure to sense the 5.07 (10g) monofilament test in one or more of the six sites tested (31;32)
- Age 50-80 years old
- Able to ambulate independently without assistive devices (e.g. walker or crutches) (8) for 30 feet.
- No evidence of neurological (other than peripheral neuropathy) or orthopedic conditions
Who cannot join
- Other non-diabetic causes of neuropathy by history
- Symptomatic peripheral vascular disease
- Joint pain, swelling and/or limited of range of motion in the lower extremities that interfere with walking or exercise
- Visual problems not correctable with glasses or contact lens
- Passive range of motion limitations are described as:
- Hip flexion < 1000;
Show all 19Show fewer
- Hip extension < 200;
- Knee flexion < 1250;
- Knee extension < 00 (unable to obtain full extension);
- Ankle plantar flexion < 250;
- Ankle dorsiflexion < 150
- Other systemic or local diseases that could interfere with walking assessment
- Severe systemic diseases other than diabetes or its complications, especially those interfering with exercise tolerance
- Amputation in the lower extremities
- Terminal illness
- Severe obesity: BMI>30 kg/m2 (33)
- Severe foot deformities (e.g. flexion contracture of the toes, pes cavus, Charcot disease)
- Mini-mental status of <27 or diagnosis of dementia
- History of alcohol or drug abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, 90073
About this study
The purpose of this study is to determine whether individuals with diabetic peripheral neuropathy can learn to change the way they walk in order to reduce the pressures underneath the feet, which may lead to a reduced risk of foot ulceration.
Read the detailed description
This study suggests that teaching a new strategy is beneficial to decrease the forefoot peak plantar pressure in individuals who are susceptible to plantar ulcerations. It has not, however, been studied whether these changes would be maintained long-term or if they had any effect on the ulceration rate. Additionally, no analysis of the amount of visual feedback necessary to elicit the desired motor pattern was discussed. It has been suggested that proprioception plays an integral role in the use of feedback to develop error-detection mechanisms by integrating visual feedback and kinesthetic variables. In the diabetic peripheral neuropathy subject population, proprioception and kinesthesia may be compromised. This may have effects on the ability of this population to maintain changes in inappropriate movement patterns. A significant portion of patients continue to develop plantar ulcers even with prescriptive footwear compliance, so gait training to change inappropriate patterns which result in the high plantar pressures may be critical to prevent ulceration.
Comparisons: Two groups of subjects will receive gait training, one group will receive feedback of performance while the other will only receive training, and one control group. Comparisons will include whether plantar pressures are decreased in the training groups, and if those changes are maintained long-term.
- Conditions
- Diabetes, Peripheral Neuropathy
- Being tested
- Gait Training with Feedback, Gait Training with no feedback
- Keywords
- Diabetes, Peripheral Neuropathy, Walking
- Medical subject headings
- Diabetes Mellitus, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait Training with FeedbackBehavioural
Gait Training with no feedbackBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Not described Receives: Behavioral: Gait Training with Feedback; Behavioral: Gait Training with no feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plantar Pressure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startMay 2004
- Primary completionSep 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- Karen Perell, PhD RKT, Principal investigator, VA Greater Los Angeles Healthcare System, West LA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00223782
- Sponsor's protocol ID
- A3117R
- Status last verified
- Mar 2008
- First submitted
- 14 Sep 2005
- Last updated
- 24 Mar 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Learning in Gait in Subjects With Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT00223782
- Acronym / sponsor ID
- A3117R
- Conditions
- Diabetes, Peripheral Neuropathy
- Keywords
- Diabetes, Peripheral Neuropathy, Walking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- May 2004
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 22 Sep 2005 (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.
The purpose of this study is to determine whether individuals with diabetic peripheral neuropathy can learn to change the way they walk in order to reduce the pressures underneath the feet, which may lead to a reduced risk of foot ulceration.
Detailed description
This study suggests that teaching a new strategy is beneficial to decrease the forefoot peak plantar pressure in individuals who are susceptible to plantar ulcerations. It has not, however, been studied whether these changes would be maintained long-term or if they had any effect on the ulceration rate. Additionally, no analysis of the amount of visual feedback necessary to elicit the desired motor pattern was discussed. It has been suggested that proprioception plays an integral role in the use of feedback to develop error-detection mechanisms by integrating visual feedback and kinesthetic variables. In the diabetic peripheral neuropathy subject population, proprioception and kinesthesia may be compromised. This may have effects on the ability of this population to maintain changes in inappropriate movement patterns. A significant portion of patients continue to develop plantar ulcers even with prescriptive footwear compliance, so gait training to change inappropriate patterns which result in the high plantar pressures may be critical to prevent ulceration.
Comparisons: Two groups of subjects will receive gait training, one group will receive feedback of performance while the other will only receive training, and one control group. Comparisons will include whether plantar pressures are decreased in the training groups, and if those changes are maintained long-term.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Behavioral: Gait Training with Feedback, Behavioral: Gait Training with no feedback |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of diabetes for at least one year.
- Diabetic peripheral neuropathy as defined by failure to sense the 5.07 (10g) monofilament test in one or more of the six sites tested (31;32)
- Age 50-80 years old
- Able to ambulate independently without assistive devices (e.g. walker or crutches) (8) for 30 feet.
- No evidence of neurological (other than peripheral neuropathy) or orthopedic conditions
Key exclusion criteria (19 listed)
- Other non-diabetic causes of neuropathy by history
- Symptomatic peripheral vascular disease
- Joint pain, swelling and/or limited of range of motion in the lower extremities that interfere with walking or exercise
- Visual problems not correctable with glasses or contact lens
- Passive range of motion limitations are described as:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gait Training with Feedback | Behavioural | 1 |
| Gait Training with no feedback | Behavioural | 1 |
Primary outcome
Plantar Pressure
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 24 Mar 2008.
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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.
Karen Perell, PhD RKT principal investigator
VA Greater Los Angeles Healthcare System, West LA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait Training with Feedback and Gait Training with no feedback in people with Diabetes and Peripheral Neuropathy, run by US Department of Veterans Affairs at 1 site 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 5 inclusion and 19 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 24 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does the primary outcome measure?
Plantar Pressure. It is what the study was designed to measure, not a finding.
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 24 Mar 2008.