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OpenTrials
Completed

NCT Number: NCT00985881

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Amputee subjects:

  • unilateral transtibial amputee of diabetic etiology,
  • have been fit with a prosthesis and have used a prosthesis for at least one year,
  • wear the prosthesis at least 4 hours per day,
  • ambulate without upper extremity aids,
  • have no history of injurious falls within the previous six months, and
  • touch sensation measured by a 10 gauge Semmes-Weinstein Monofilament in the dermatomes of their residual limb.

Exclusion criteria

Subjects will be excluded if:

  • they have a significant lower extremity pain condition, musculoskeletal disorder, or neurological deficit that interferes with their ability to pursue typical daily activities or alters their gait characteristics,
  • their residual limb is ulcerated, or
  • are currently using anticonvulsant medications for the treatment of neuropathic pain.

Treatment and study plan

Custom prosthetic socket with mechanical vibrators (stochastic resonance)

Device

Application of mechanically-induced sub-threshold vibration applied to the amputee's residual limb using a custom prosthetic limb system

Conventional prosthetic socket (current clinical practice)

Device

No sub-threshold vibration applied to residual limb. Amputee wears conventional prosthetic socket.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • University of Texas

Registry information

Official study title

Mechanically-induced Stochastic Resonance to Improve Amputee Gait

Important dates

Study start
2007
Primary completion
2018
Study completion
2018
First posted
Sep 29, 2009
Registry last updated
Jun 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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