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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 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: July 29, 2014
Last verified: July 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Mechanically-induced Stochastic Resonance to Improve Amputee Gait

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: April 2007
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
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
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Recruiting
Seattle, Washington, United States, 98108
Contact: Wesley D Edmundson    206-764-2991    wesley.edmundson@va.gov   
Contact: Janice A Pecoraro, RN    (206) 764-2962    janice.pecoraro@va.gov   
Principal Investigator: Glenn K. Klute, PhD         
Sponsors and Collaborators
University of Texas
Investigators
Principal Investigator: Glenn K. Klute, PhD VA Puget Sound Health Care System, Seattle
  More Information

Additional Information:
No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00985881     History of Changes
Other Study ID Numbers: A4376-R
Study First Received: March 25, 2008
Last Updated: July 29, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Artificial limbs
Gait
Posture
Prosthesis
Vibration

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

ClinicalTrials.gov processed this record on September 22, 2014