NCT00985881

Use of Subtle Vibration to Improve Walking Ability by Lower Limb Amputees

Mechanically-induced Stochastic Resonance to Improve Amputee Gait

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if subthreshold vibration, when applied to the residual limb of a lower limb amputee through their prosthetic socket, can sufficiently enhance peripheral sensation to result in an improved ability to balance and walk.

Detailed description

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.

Conditions

• Amputation
• Diabetes Complications

Interventions

Type	Name	Description
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
DEVICE	Conventional prosthetic socket (current clinical practice)	No sub-threshold vibration applied to residual limb. Amputee wears conventional prosthetic socket.

Timeline

• Start date: 2007-04-01
• Primary completion: 2018-06-25
• Completion: 2018-06-25
• First posted: 2009-09-29
• Last updated: 2018-06-29

Locations

1 site across 1 country: United States