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Motor Learning in Gait in Subjects With Diabetic Peripheral Neuropathy

Primary Purpose

Diabetes, Peripheral Neuropathy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gait Training with Feedback
Gait Training with no feedback
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes focused on measuring Diabetes, Peripheral Neuropathy, Walking

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Criteria: 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

Sites / Locations

  • VA Greater Los Angeles Healthcare System, West LA

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Plantar Pressure

Secondary Outcome Measures

Full Information

First Posted
September 14, 2005
Last Updated
March 21, 2008
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00223782
Brief Title
Motor Learning in Gait in Subjects With Diabetic Peripheral Neuropathy
Official Title
Motor Learning in Gait in Subjects With Diabetic Peripheral Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Peripheral Neuropathy
Keywords
Diabetes, Peripheral Neuropathy, Walking

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Gait Training with Feedback
Intervention Type
Behavioral
Intervention Name(s)
Gait Training with no feedback
Primary Outcome Measure Information:
Title
Plantar Pressure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Perell, PhD RKT
Organizational Affiliation
VA Greater Los Angeles Healthcare System, West LA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Greater Los Angeles Healthcare System, West LA
City
West Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States

12. IPD Sharing Statement

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Motor Learning in Gait in Subjects With Diabetic Peripheral Neuropathy

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