Motor Learning in Gait in Subjects With Diabetic Peripheral Neuropathy

Diabetes Clinical Trial

Official title:

Motor Learning in Gait in Subjects With Diabetic Peripheral Neuropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00223782
• Other study ID #: A3117R
• Status: Completed
• Phase: N/A
• First received: September 14, 2005
• Last updated: March 21, 2008
• Start date: May 2004
• Est. completion date: September 2006

Study information

• Verified date: March 2008
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes
• Diabetic Neuropathies
• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Intervention

Behavioral:
• Gait Training with Feedback

• Gait Training with no feedback

Locations

Country	Name	City	State
United States	VA Greater Los Angeles Healthcare System, West LA	West Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plantar Pressure			No