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

This study is currently recruiting participants.
Verified February 2014 by Department of Veterans Affairs
Sponsor:
Collaborator:
University of Texas
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00985881
First received: March 25, 2008
Last updated: March 3, 2014
Last verified: February 2014

March 25, 2008
March 3, 2014
April 2007
June 2015   (final data collection date for primary outcome measure)
Gait variability [ Time Frame: Testing with and without stochastic resonance will occur within a single laboratory visit on one day ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00985881 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Use of Subtle Vibration to Improve Walking Ability by Lower Limb Amputees
Mechanically-induced Stochastic Resonance to Improve Amputee Gait

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.

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.

Our work proposes to explore the use of a novel prosthetic intervention for diabetic lower limb amputees. We hypothesize that our 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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Amputation
  • Diabetes Complications
  • 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.
  • Experimental: Arm 1
    Mechanical stochastic resonance
    Intervention: Device: Custom prosthetic socket with mechanical vibrators (stochastic resonance)
  • Arm 2
    Current clinical practice
    Intervention: Device: Conventional prosthetic socket (current clinical practice)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
September 2015
June 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact: Janice A Pecoraro, RN (206) 764-2962 janice.pecoraro@va.gov
United States
 
NCT00985881
A4376-R
No
Department of Veterans Affairs
Department of Veterans Affairs
University of Texas
Principal Investigator: Glenn K. Klute, PhD VA Puget Sound Health Care System, Seattle
Department of Veterans Affairs
February 2014

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