Status:

COMPLETED

Motor Learning in Gait in Subjects With Diabetic Peripheral Neuropathy

Lead Sponsor:

US Department of Veterans Affairs

Conditions:

Diabetes

Peripheral Neuropathy

Eligibility:

All Genders

50-80 years

Phase:

NA

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 ...

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 studi...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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;
  • 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

Key Trial Info

Start Date :

May 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 1 2006

Estimated Enrollment :

150 Patients enrolled

Trial Details

Trial ID

NCT00223782

Start Date

May 1 2004

End Date

September 1 2006

Last Update

March 24 2008

Active Locations (1)

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1

VA Greater Los Angeles Healthcare System, West LA

West Los Angeles, California, United States, 90073