Use of Subtle Vibration to Improve Walking Ability by Lower Limb Amputees
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00985881|
Recruitment Status : Completed
First Posted : September 29, 2009
Last Update Posted : June 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Amputation Diabetes Complications||Device: Custom prosthetic socket with mechanical vibrators (stochastic resonance) Device: Conventional prosthetic socket (current clinical practice)||Not Applicable|
One of the many complications of diabetes is the loss of sensation in the feet. This sensory deficit can negatively impact the postural stability and mobility of non-amputees, since without feedback, it is simply more difficult to stand and walk. For lower limb amputees, the problem is compounded. These patients often have difficulty with prosthetic limb placement during maneuvering tasks, exhibit dramatic increases in the movement of their center of pressure during quiet standing, and both clinical and observational gait analysis reveal significant changes in their gait pattern relative to non-amputees.
The investigators' work proposes to explore the use of a novel prosthetic intervention for diabetic lower limb amputees. The investigators hypothesize that the intervention will sufficiently enhance proprioception to result in measurably improved postural stability and locomotor function for these patients. The intervention is based on a phenomenon known as stochastic resonance, whereby the application of sub-threshold vibration enables mechano-receptors previously unable to respond to stimuli to become more susceptible to depolarization. For Veterans with neuropathic proprioceptive losses, stochastic resonance may facilitate a functional response from subtle stimuli where gross inputs were formerly required.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Factorial Assignment|
|Official Title:||Mechanically-induced Stochastic Resonance to Improve Amputee Gait|
|Actual Study Start Date :||April 1, 2007|
|Actual Primary Completion Date :||June 25, 2018|
|Actual Study Completion Date :||June 25, 2018|
Experimental: Arm 1: stochastic resonance
Mechanical stochastic resonance
Device: Custom prosthetic socket with mechanical vibrators (stochastic resonance)
Application of mechanically-induced sub-threshold vibration applied to the amputee's residual limb using a custom prosthetic limb system
Arm 2: current clinical practice
Current clinical practice
Device: Conventional prosthetic socket (current clinical practice)
No sub-threshold vibration applied to residual limb. Amputee wears conventional prosthetic socket.
- Gait variability [ Time Frame: Testing with and without stochastic resonance will occur within a single laboratory visit on one day ]Self-selected walking speed (mean and standard deviation) in meters/second
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00985881
|United States, Washington|
|VA Puget Sound Health Care System Seattle Division, Seattle, WA|
|Seattle, Washington, United States, 98108|
|Principal Investigator:||Glenn K Klute, PhD||VA Puget Sound Health Care System Seattle Division, Seattle, WA|