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

This study is currently recruiting participants.
Verified June 2017 by VA Office of Research and Development
Sponsor:
ClinicalTrials.gov Identifier:
NCT00985881
First Posted: September 29, 2009
Last Update Posted: July 2, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
University of Texas
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose
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 Intervention
Amputation Diabetes Complications Device: Custom prosthetic socket with mechanical vibrators (stochastic resonance) Device: Conventional prosthetic socket (current clinical practice)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Mechanically-induced Stochastic Resonance to Improve Amputee Gait

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 40
Actual Study Start Date: April 1, 2007
Estimated Study Completion Date: August 30, 2019
Estimated Primary Completion Date: February 28, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Information from the National Library of Medicine

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

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00985881


Contacts
Contact: Janice A Pecoraro, RN (206) 764-2962 janice.pecoraro@va.gov

Locations
United States, Washington
VA Puget Sound Health Care System Seattle Division, Seattle, WA Recruiting
Seattle, Washington, United States, 98108
Contact: Charles G Keelin    206-764-2028    charles.keelin2@va.gov   
Contact: Janice A Pecoraro, RN    (206) 764-2962    janice.pecoraro@va.gov   
Principal Investigator: Glenn K Klute, PhD         
Sponsors and Collaborators
VA Office of Research and Development
University of Texas
Investigators
Principal Investigator: Glenn K Klute, PhD VA Puget Sound Health Care System Seattle Division, Seattle, WA
  More Information

Additional Information:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00985881     History of Changes
Other Study ID Numbers: A4376-R
First Submitted: March 25, 2008
First Posted: September 29, 2009
Last Update Posted: July 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
Gait
Posture
Prosthesis
Vibration

Additional relevant MeSH terms:
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases


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