Status:
COMPLETED
Use of Subtle Vibration to Improve Walking Ability by Lower Limb Amputees
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
University of Texas
Conditions:
Amputation
Diabetes Complications
Eligibility:
All Genders
18-70 years
Phase:
NA
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 sens...
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, ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2018
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00985881
Start Date
April 1 2007
End Date
June 25 2018
Last Update
June 29 2018
Active Locations (1)
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1
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States, 98108