Clinical trial NCT00223782: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Peripheral Neuropathy
Keywords: Diabetes
Peripheral Neuropathy
Walking
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-09-22
Enrollment: 150
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Plantar Pressure
Secondary outcomes:
Other outcomes:
Locations:
city: West Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System, West LA
state: California
Study officials:
affiliation: VA Greater Los Angeles Healthcare System, West LA
name: Karen Perell, PhD RKT
role: PRINCIPAL_INVESTIGATOR
References: