Use of Subtle Vibration to Improve Walking Ability by Lower Limb Amputees
Primary Purpose
Amputation, Diabetes Complications
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Custom prosthetic socket with mechanical vibrators (stochastic resonance)
Conventional prosthetic socket (current clinical practice)
Sponsored by
About this trial
This is an interventional treatment trial for Amputation focused on measuring Artificial limbs, Gait, Posture, Prosthesis, Vibration
Eligibility 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.
Sites / Locations
- VA Puget Sound Health Care System Seattle Division, Seattle, WA
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Arm 1: stochastic resonance
Arm 2: current clinical practice
Arm Description
Mechanical stochastic resonance
Current clinical practice
Outcomes
Primary Outcome Measures
Gait variability
Self-selected walking speed (mean and standard deviation) in meters/second
Secondary Outcome Measures
Full Information
NCT ID
NCT00985881
First Posted
March 25, 2008
Last Updated
June 28, 2018
Sponsor
VA Office of Research and Development
Collaborators
University of Texas
1. Study Identification
Unique Protocol Identification Number
NCT00985881
Brief Title
Use of Subtle Vibration to Improve Walking Ability by Lower Limb Amputees
Official Title
Mechanically-induced Stochastic Resonance to Improve Amputee Gait
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
April 1, 2007 (Actual)
Primary Completion Date
June 25, 2018 (Actual)
Study Completion Date
June 25, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
University of Texas
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amputation, Diabetes Complications
Keywords
Artificial limbs, Gait, Posture, Prosthesis, Vibration
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: stochastic resonance
Arm Type
Experimental
Arm Description
Mechanical stochastic resonance
Arm Title
Arm 2: current clinical practice
Arm Type
Other
Arm Description
Current clinical practice
Intervention Type
Device
Intervention Name(s)
Custom prosthetic socket with mechanical vibrators (stochastic resonance)
Intervention Description
Application of mechanically-induced sub-threshold vibration applied to the amputee's residual limb using a custom prosthetic limb system
Intervention Type
Device
Intervention Name(s)
Conventional prosthetic socket (current clinical practice)
Intervention Description
No sub-threshold vibration applied to residual limb. Amputee wears conventional prosthetic socket.
Primary Outcome Measure Information:
Title
Gait variability
Description
Self-selected walking speed (mean and standard deviation) in meters/second
Time Frame
Testing with and without stochastic resonance will occur within a single laboratory visit on one day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glenn K Klute, PhD
Organizational Affiliation
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Puget Sound Health Care System Seattle Division, Seattle, WA
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.amputation.research.va.gov/
Description
Click here for more information about this study: Mechanically-induced Stochastic Resonance to Improve Amputee Gait
Learn more about this trial
Use of Subtle Vibration to Improve Walking Ability by Lower Limb Amputees
We'll reach out to this number within 24 hrs