Motor Learning in Gait in Subjects With Diabetic Peripheral Neuropathy

March 21, 2008 updated by: US Department of Veterans Affairs
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.

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • West Los Angeles, California, United States, 90073
        • VA Greater Los Angeles Healthcare System, West LA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Diagnosis of diabetes for at least one year.
  2. 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)
  3. Age 50-80 years old
  4. Able to ambulate independently without assistive devices (e.g. walker or crutches) (8) for 30 feet.
  5. No evidence of neurological (other than peripheral neuropathy) or orthopedic conditions

Exclusion Criteria:

  1. Other non-diabetic causes of neuropathy by history
  2. Symptomatic peripheral vascular disease
  3. Joint pain, swelling and/or limited of range of motion in the lower extremities that interfere with walking or exercise
  4. Visual problems not correctable with glasses or contact lens
  5. Passive range of motion limitations are described as:

    1. Hip flexion < 1000;
    2. Hip extension < 200;
    3. Knee flexion < 1250;
    4. Knee extension < 00 (unable to obtain full extension);
    5. Ankle plantar flexion < 250;
    6. Ankle dorsiflexion < 150
  6. Other systemic or local diseases that could interfere with walking assessment
  7. Severe systemic diseases other than diabetes or its complications, especially those interfering with exercise tolerance
  8. Amputation in the lower extremities
  9. Terminal illness
  10. Severe obesity: BMI>30 kg/m2 (33)
  11. Severe foot deformities (e.g. flexion contracture of the toes, pes cavus, Charcot disease)
  12. Mini-mental status of <27 or diagnosis of dementia
  13. History of alcohol or drug abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Plantar Pressure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Karen Perell, PhD RKT, VA Greater Los Angeles Healthcare System, West LA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

March 24, 2008

Last Update Submitted That Met QC Criteria

March 21, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Other Study ID Numbers

  • A3117R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes

Clinical Trials on Gait Training with Feedback

3
Subscribe