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

Tracking Information
First Submitted Date  ICMJE March 25, 2008
First Posted Date  ICMJE September 29, 2009
Last Update Posted Date June 29, 2018
Actual Study Start Date  ICMJE April 1, 2007
Actual Primary Completion Date June 25, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2017)
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
Original Primary Outcome Measures  ICMJE
 (submitted: September 28, 2009)
Gait variability [ Time Frame: Testing with and without stochastic resonance will occur within a single laboratory visit on one day ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of Subtle Vibration to Improve Walking Ability by Lower Limb Amputees
Official Title  ICMJE Mechanically-induced Stochastic Resonance to Improve Amputee Gait
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Amputation
  • Diabetes Complications
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Arm 1: stochastic resonance
    Mechanical stochastic resonance
    Intervention: Device: Custom prosthetic socket with mechanical vibrators (stochastic resonance)
  • Arm 2: current clinical practice
    Current clinical practice
    Intervention: Device: Conventional prosthetic socket (current clinical practice)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 28, 2018)
17
Original Estimated Enrollment  ICMJE
 (submitted: September 28, 2009)
40
Actual Study Completion Date  ICMJE June 25, 2018
Actual Primary Completion Date June 25, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00985881
Other Study ID Numbers  ICMJE A4376-R
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE University of Texas
Investigators  ICMJE
Principal Investigator: Glenn K Klute, PhD VA Puget Sound Health Care System Seattle Division, Seattle, WA
PRS Account VA Office of Research and Development
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP