Use of Subtle Vibration to Improve Walking Ability by Lower Limb Amputees
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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 |
- 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 2014 |
| Estimated Primary Completion Date: | June 2014 (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 |
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| Contact: Janice A Pecoraro, RN | (206) 764-2962 | janice.pecoraro@va.gov |
| United States, Washington | |
| VA Puget Sound Health Care System, Seattle | Recruiting |
| Seattle, Washington, United States, 98108 | |
| Contact: Wesley 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 | |
| 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: | April 16, 2013 |
| 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 May 19, 2013