Motor Learning in Gait in Subjects With Diabetic Peripheral Neuropathy

Sponsor
US Department of Veterans Affairs (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT00223782
Collaborator
(none)
150
1
1
28
5.4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Gait Training with Feedback
  • Behavioral: Gait Training with no feedback
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Motor Learning in Gait in Subjects With Diabetic Peripheral Neuropathy
Study Start Date :
May 1, 2004
Actual Primary Completion Date :
Sep 1, 2006
Actual Study Completion Date :
Sep 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Other: 1

Behavioral: Gait Training with Feedback

Behavioral: Gait Training with no feedback

Outcome Measures

Primary Outcome Measures

  1. Plantar Pressure []

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:

  6. Hip flexion < 1000;

  7. Hip extension < 200;

  8. Knee flexion < 1250;

  9. Knee extension < 00 (unable to obtain full extension);

  10. Ankle plantar flexion < 250;

  11. Ankle dorsiflexion < 150

  12. Other systemic or local diseases that could interfere with walking assessment

  13. Severe systemic diseases other than diabetes or its complications, especially those interfering with exercise tolerance

  14. Amputation in the lower extremities

  15. Terminal illness

  16. Severe obesity: BMI>30 kg/m2 (33)

  17. Severe foot deformities (e.g. flexion contracture of the toes, pes cavus, Charcot disease)

  18. Mini-mental status of <27 or diagnosis of dementia

  19. History of alcohol or drug abuse

Contacts and Locations

Locations

Site City State Country Postal Code
1 VA Greater Los Angeles Healthcare System, West LA West Los Angeles California United States 90073

Sponsors and Collaborators

  • US Department of Veterans Affairs

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00223782
Other Study ID Numbers:
  • A3117R
First Posted:
Sep 22, 2005
Last Update Posted:
Mar 24, 2008
Last Verified:
Mar 1, 2008
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 24, 2008