Motor Learning in Gait in Subjects With Diabetic Peripheral Neuropathy

NCT00223782 | Completed

• 1 other identifier: A3117R
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Peripheral Neuropathy

Keywords

Diabetes; Peripheral Neuropathy; Walking

Outcome Measures

Primary Outcomes (1)

• Plantar Pressure

Study Arms (1)

1

OTHER

Behavioral: Gait Training with Feedback; Behavioral: Gait Training with no feedback

Interventions

Gait Training with Feedback BEHAVIORAL

1

Gait Training with no feedback BEHAVIORAL

1

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA Greater Los Angeles Healthcare System, West LA

West Los Angeles, California, 90073, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Karen Perell, PhD RKT

  VA Greater Los Angeles Healthcare System, West LA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 22, 2005
• Study Start: May 1, 2004
• Primary Completion: September 1, 2006
• Study Completion: September 1, 2006
• Last Updated: March 24, 2008

Record last verified: 2008-03

Locations

US (1)