Motor Learning in Gait in Subjects With Diabetic Peripheral Neuropathy

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00223782
First received: September 14, 2005
Last updated: March 21, 2008
Last verified: March 2008
  Purpose

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.


Condition Intervention
Diabetes
Peripheral Neuropathy
Behavioral: Gait Training with Feedback
Behavioral: Gait Training with no feedback

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Motor Learning in Gait in Subjects With Diabetic Peripheral Neuropathy

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Plantar Pressure [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: May 2004
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Behavioral: Gait Training with Feedback Behavioral: Gait Training with no feedback

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.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00223782

Locations
United States, California
VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, United States, 90073
Sponsors and Collaborators
Investigators
Principal Investigator: Karen Perell, PhD RKT VA Greater Los Angeles Healthcare System, West LA
  More Information

No publications provided

Responsible Party: Perell, Karen - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00223782     History of Changes
Other Study ID Numbers: A3117R
Study First Received: September 14, 2005
Last Updated: March 21, 2008
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Diabetes
Peripheral Neuropathy
Walking

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

ClinicalTrials.gov processed this record on August 28, 2014