Motor Learning in Gait in Subjects With Diabetic Peripheral Neuropathy
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.
Behavioral: Gait Training with Feedback
Behavioral: Gait Training with no feedback
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Motor Learning in Gait in Subjects With Diabetic Peripheral Neuropathy|
- Plantar Pressure [ Designated as safety issue: No ]
|Study Start Date:||May 2004|
|Study Completion Date:||September 2006|
|Primary Completion Date:||September 2006 (Final data collection date for primary outcome measure)|
|1||Behavioral: Gait Training with Feedback Behavioral: Gait Training with no feedback|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00223782
|United States, California|
|VA Greater Los Angeles Healthcare System, West LA|
|West Los Angeles, California, United States, 90073|
|Principal Investigator:||Karen Perell, PhD RKT||VA Greater Los Angeles Healthcare System, West LA|