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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. Identifier: NCT00985881
Recruitment Status : Completed
First Posted : September 29, 2009
Last Update Posted : June 29, 2018
University of Texas
Information provided by (Responsible Party):
VA Office of Research and Development

Brief 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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Limb Loss

Arm Intervention/treatment
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.

Primary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00985881

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United States, Washington
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States, 98108
Sponsors and Collaborators
VA Office of Research and Development
University of Texas
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Principal Investigator: Glenn K Klute, PhD VA Puget Sound Health Care System Seattle Division, Seattle, WA
Additional Information:
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Responsible Party: VA Office of Research and Development Identifier: NCT00985881    
Other Study ID Numbers: A4376-R
First Posted: September 29, 2009    Key Record Dates
Last Update Posted: June 29, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Artificial limbs
Additional relevant MeSH terms:
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Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases